Exponential Technology Report 2026: Genomics and Gene Editing

S.1Abstract

S.2Key messages

Six readings that frame the genomics baseline, and the eight questions this edition answers, each with its status and source.

1. In two phase 3 studies most evaluable patients met the primary end point at short follow-up.²³

   Do editing therapies work?Reported

2. The FDA approved Casgevy on 8 December 2023 for patients 12 and older.¹

   Is the approval real?Reported

3. One infant received a patient-specific base editor in 2025; one case is not a trend.⁴

   Can a therapy be made for one patient?Reported

4. No. A 2023 death after high-dose viral vector therapy and a 2025 liver event show open risks.⁹¹⁰

   Is the safety record settled?Reported

5. A complete genome of 3.055 billion base pairs and genome releases of 245,388 and 490,640 people.¹¹¹⁶¹⁷

   How large are the data resources?Reported

6. Vendor pages claim list prices; independent cost data were not read.¹⁴¹⁵

   What does a genome cost?Reported

7. The Third Summit judged it unacceptable at this time; national rules differ.²⁷²⁸

   What are the rules on heritable editing?Reported

8. Whether delivery, payment and oversight can keep pace with individualised editing. SCN-XT05-DLV-01

   What will 2027 test first?Expert input

S.3Headline finding

ReportedEQL 4NRF-XTECH-GENOMICS-GLOBAL-2026-BASELINE-HLT-001

In a phase 3 study of exa-cel in severe sickle cell disease, 29 of 30 evaluable patients (97%) were free of severe vaso-occlusive crises for at least 12 consecutive months.

The result supports reading ex vivo editing of blood stem cells as a working therapy for one disease. Median follow-up was 19.3 months, patients needed myeloablative conditioning, and no cancers occurred in the period reported. The FDA approved the product on 8 December 2023 for patients 12 and older¹².

S.4At a glance

S.5What each steward reads in it

S.6What this edition is, and is not

Notes

Numbers are the edition’s reference numbers, so a note reads the same in every chapter. The full list, with every source and its licence, is in Annex C. Annex C, references

1. 2Frangoul, H. et al., Exagamglogene Autotemcel for Severe Sickle Cell Disease, New England Journal of Medicine 2024 (abstract read through the Europe PMC record; 44 treated, 30 evaluable, 29 free of crises for 12 months or more). Massachusetts Medical Society, Waltham. Observation year 2024. Accessed 2026-11-03.back
2. 3Locatelli, F. et al., Exagamglogene Autotemcel for Transfusion-Dependent beta-Thalassemia, New England Journal of Medicine 2024 (abstract read through the Europe PMC record; 52 treated, 35 evaluable, 32 transfusion independent). Massachusetts Medical Society, Waltham. Observation year 2024. Accessed 2026-11-03.back
3. 1US Food and Drug Administration (ed.), FDA approves first gene therapies to treat patients with sickle cell disease (press announcement, 8 December 2023; Casgevy uses CRISPR/Cas9, Lyfgenia a lentiviral vector; patients 12 years and older). FDA, Silver Spring. Observation year 2023. Accessed 2026-11-03.back
4. 4Musunuru, K. et al., Patient-Specific In Vivo Gene Editing to Treat a Rare Genetic Disease, New England Journal of Medicine 2025 (abstract read through the Europe PMC record; one infant, two infusions at about 7 and 8 months of age). Massachusetts Medical Society, Waltham. Observation year 2025. Accessed 2026-11-03.back
5. 11Nurk, S. et al., The complete sequence of a human genome, Science 2022 (abstract read through the Europe PMC record; 3.055 billion base pairs; nearly 200 million base pairs of new sequence). American Association for the Advancement of Science, Washington. Observation year 2022. Accessed 2026-11-03.back
6. 16UK Biobank Whole-Genome Sequencing Consortium, Whole-genome sequencing of 490,640 UK Biobank participants, Nature 2025 (abstract read through the Europe PMC record). Springer Nature, London. Observation year 2025. Accessed 2026-11-03.back
7. 17All of Us Research Program Genomics Investigators, Genomic data in the All of Us Research Program, Nature 2024 (abstract read through the Europe PMC record; 245,388 genomes; 77% from communities under-represented in research). Springer Nature, London. Observation year 2024. Accessed 2026-11-03.back
8. 15Ultima Genomics (ed.), germline genetics product page (vendor claim of a USD 60 genome at list price over 4 wafers on the UG200 series; the browser title reads USD 80; vendor evidence, weak). Ultima Genomics, Newark. Observation year 2026. Accessed 2026-11-03.back
9. 21Grealey, J. et al., The Carbon Footprint of Bioinformatics, Molecular Biology and Evolution 2022 (abstract read through the Europe PMC record; a software upgrade cut one tool footprint by 73%). Oxford University Press, Oxford. Observation year 2022. Accessed 2026-11-03.back
10. 30Latham and Watkins (ed.), BIOSECURE Act becomes law, limiting grants with biotechnology companies of concern (law-firm summary; enacted 18 December 2025 in the FY2026 NDAA; OMB list due by 18 December 2026; secondary source of a statute). Latham and Watkins, Los Angeles. Observation year 2025. Accessed 2026-11-03.back
11. 31MedTech Dive (ed.), China to lift Illumina export ban (trade press, November 2025; listing in February 2025, import ban in March 2025, lift on 10 November 2025, instrument sales in China down 54% in the third quarter; secondary report, weak evidence). Industry Dive, Washington. Observation year 2025. Accessed 2026-11-03.back
12. 28Royal Society (ed.), Statement from the Organising Committee of the Third International Summit on Human Genome Editing (8 March 2023; convened by the Royal Society, the Academy of Medical Sciences, the US National Academies and The World Academy of Sciences). Royal Society, London. Observation year 2023. Accessed 2026-11-03.back
13. 9BioSpace (ed.), Life-threatening liver toxicity triggers FDA freeze on two Intellia gene therapy studies (trade press, 30 October 2025; relays company disclosures; secondary report, weak evidence). BioSpace, Boston. Observation year 2025. Accessed 2026-11-03.back
14. 10Lek, A. et al., Death after High-Dose rAAV9 Gene Therapy in a Patient with Duchenne Muscular Dystrophy, New England Journal of Medicine 2023 (abstract read through the Europe PMC record). Massachusetts Medical Society, Waltham. Observation year 2023. Accessed 2026-11-03.back
15. 14Illumina (ed.), NovaSeq X Series product page (vendor claims: 16 to 21 Tb per run for NovaSeq X Plus, more than 128 genomes per run, run time about 14 to 48 hours; vendor evidence, weak). Illumina, San Diego. Observation year 2026. Accessed 2026-11-03.back
16. 27World Health Organization (ed.), Human genome editing: a framework for governance (technical document, 12 July 2021; companion recommendations published separately and not read). WHO, Geneva. Observation year 2021. Accessed 2026-11-03.back
17. 6Vertex Pharmaceuticals (ed.), Vertex Reports First Quarter 2026 Financial Results (company press release read through a wire page; Casgevy revenue USD 42.9 million against USD 14.2 million; pediatric submission completed; company statement, weak evidence). Vertex, Boston. Observation year 2026. Accessed 2026-11-03.back

1.1The questions this part answers

Key questions

• Where is genomics risk concentrated?
• Which couplings carry genomics shocks into other systems?
• Which genomics capabilities hold under compound stress?
• What must 2027 evidence measure first?

In this part

• Narrative
• Headline finding
• Lead figure
• Five footprint and governance chapters
• Twelve-domain reading
• Sector screens
• Dependency matrix
• Risk objects
• Capability ladder
• Scenario
• Three lenses
• Portfolio

1.2The argument

1.3Twenty couplings between five systems

The genomics-centred matrix types the twenty couplings between the five core systems, read for their genomics content. Strengths are Nexus estimates (ESTIMATED) from the cited evidence and analogue events; they set the graph that 2027 evidence will test.

Transmission paths

1. 01

   DAT → HLT

   Reference genomes and biobanks inform diagnosis and therapy targets.

   Inferred T2T, UK Biobank and All of Us¹¹¹⁶¹⁷

2. 02

   TRD → INF

   Trade rules change sequencer supply.

   Reported Illumina China bans and BIOSECURE³⁰³¹

3. 03

   FIN → HLT

   Payment and manufacturing capacity limit therapy access.

   Reported cost-effectiveness analysis and company report⁶⁷

4. 04

   ENE → INF

   Compute and cold chain power shape the cost of scale.

   Inferred carbon footprint studies²¹²²

5. 05

   GOV → HLT

   Approval pathways and heritable-editing limits set what reaches patients.

   Reported FDA and Third Summit¹⁵²⁸

Notes

Numbers are the edition’s reference numbers, so a note reads the same in every chapter. The full list, with every source and its licence, is in Annex C. Annex C, references

1. 11Nurk, S. et al., The complete sequence of a human genome, Science 2022 (abstract read through the Europe PMC record; 3.055 billion base pairs; nearly 200 million base pairs of new sequence). American Association for the Advancement of Science, Washington. Observation year 2022. Accessed 2026-11-03.back
2. 16UK Biobank Whole-Genome Sequencing Consortium, Whole-genome sequencing of 490,640 UK Biobank participants, Nature 2025 (abstract read through the Europe PMC record). Springer Nature, London. Observation year 2025. Accessed 2026-11-03.back
3. 1US Food and Drug Administration (ed.), FDA approves first gene therapies to treat patients with sickle cell disease (press announcement, 8 December 2023; Casgevy uses CRISPR/Cas9, Lyfgenia a lentiviral vector; patients 12 years and older). FDA, Silver Spring. Observation year 2023. Accessed 2026-11-03.back
4. 2Frangoul, H. et al., Exagamglogene Autotemcel for Severe Sickle Cell Disease, New England Journal of Medicine 2024 (abstract read through the Europe PMC record; 44 treated, 30 evaluable, 29 free of crises for 12 months or more). Massachusetts Medical Society, Waltham. Observation year 2024. Accessed 2026-11-03.back
5. 3Locatelli, F. et al., Exagamglogene Autotemcel for Transfusion-Dependent beta-Thalassemia, New England Journal of Medicine 2024 (abstract read through the Europe PMC record; 52 treated, 35 evaluable, 32 transfusion independent). Massachusetts Medical Society, Waltham. Observation year 2024. Accessed 2026-11-03.back
6. 4Musunuru, K. et al., Patient-Specific In Vivo Gene Editing to Treat a Rare Genetic Disease, New England Journal of Medicine 2025 (abstract read through the Europe PMC record; one infant, two infusions at about 7 and 8 months of age). Massachusetts Medical Society, Waltham. Observation year 2025. Accessed 2026-11-03.back
7. 9BioSpace (ed.), Life-threatening liver toxicity triggers FDA freeze on two Intellia gene therapy studies (trade press, 30 October 2025; relays company disclosures; secondary report, weak evidence). BioSpace, Boston. Observation year 2025. Accessed 2026-11-03.back
8. 10Lek, A. et al., Death after High-Dose rAAV9 Gene Therapy in a Patient with Duchenne Muscular Dystrophy, New England Journal of Medicine 2023 (abstract read through the Europe PMC record). Massachusetts Medical Society, Waltham. Observation year 2023. Accessed 2026-11-03.back
9. 12Liao, W.-W. et al. (Human Pangenome Reference Consortium), A draft human pangenome reference, Nature 2023 (abstract read through the Europe PMC record; 47 phased diploid assemblies; 119 million base pairs added). Springer Nature, London. Observation year 2023. Accessed 2026-11-03.back
10. 17All of Us Research Program Genomics Investigators, Genomic data in the All of Us Research Program, Nature 2024 (abstract read through the Europe PMC record; 245,388 genomes; 77% from communities under-represented in research). Springer Nature, London. Observation year 2024. Accessed 2026-11-03.back
11. 18Fatumo, S. et al., A roadmap to increase diversity in genomic studies, Nature Medicine 2022 (abstract read through the Europe PMC record). Springer Nature, London. Observation year 2022. Accessed 2026-11-03.back
12. 19Sirugo, G., Williams, S.M. and Tishkoff, S.A., The Missing Diversity in Human Genetic Studies, Cell 2019 (abstract read through the Europe PMC record). Cell Press, Cambridge. Observation year 2019. Accessed 2026-11-03.back
13. 14Illumina (ed.), NovaSeq X Series product page (vendor claims: 16 to 21 Tb per run for NovaSeq X Plus, more than 128 genomes per run, run time about 14 to 48 hours; vendor evidence, weak). Illumina, San Diego. Observation year 2026. Accessed 2026-11-03.back
14. 15Ultima Genomics (ed.), germline genetics product page (vendor claim of a USD 60 genome at list price over 4 wafers on the UG200 series; the browser title reads USD 80; vendor evidence, weak). Ultima Genomics, Newark. Observation year 2026. Accessed 2026-11-03.back
15. 21Grealey, J. et al., The Carbon Footprint of Bioinformatics, Molecular Biology and Evolution 2022 (abstract read through the Europe PMC record; a software upgrade cut one tool footprint by 73%). Oxford University Press, Oxford. Observation year 2022. Accessed 2026-11-03.back
16. 30Latham and Watkins (ed.), BIOSECURE Act becomes law, limiting grants with biotechnology companies of concern (law-firm summary; enacted 18 December 2025 in the FY2026 NDAA; OMB list due by 18 December 2026; secondary source of a statute). Latham and Watkins, Los Angeles. Observation year 2025. Accessed 2026-11-03.back
17. 31MedTech Dive (ed.), China to lift Illumina export ban (trade press, November 2025; listing in February 2025, import ban in March 2025, lift on 10 November 2025, instrument sales in China down 54% in the third quarter; secondary report, weak evidence). Industry Dive, Washington. Observation year 2025. Accessed 2026-11-03.back
18. 6Vertex Pharmaceuticals (ed.), Vertex Reports First Quarter 2026 Financial Results (company press release read through a wire page; Casgevy revenue USD 42.9 million against USD 14.2 million; pediatric submission completed; company statement, weak evidence). Vertex, Boston. Observation year 2026. Accessed 2026-11-03.back
19. 7Chetlapalli, K. et al., Haploidentical transplant, gene therapy, and standard care in sickle cell disease: a cost-effectiveness analysis, Blood 2026 (abstract read through the Europe PMC record; gene therapy access limited by cost and manufacturing capacity). American Society of Hematology, Washington. Observation year 2026. Accessed 2026-11-03.back
20. 22Lannelongue, L., Grealey, J. and Inouye, M., Green Algorithms: Quantifying the Carbon Footprint of Computation, Advanced Science 2021 (abstract read through the Europe PMC record). Wiley, Weinheim. Observation year 2021. Accessed 2026-11-03.back
21. 5Clinical Trials Arena (ed.), FDA unveils new pathway to usher bespoke therapies to market (trade press, 13 November 2025; describes the plausible mechanism pathway announced in a journal article by the FDA Commissioner and the CBER Director; secondary report, weak evidence). Clinical Trials Arena, London. Observation year 2025. Accessed 2026-11-03.back
22. 28Royal Society (ed.), Statement from the Organising Committee of the Third International Summit on Human Genome Editing (8 March 2023; convened by the Royal Society, the Academy of Medical Sciences, the US National Academies and The World Academy of Sciences). Royal Society, London. Observation year 2023. Accessed 2026-11-03.back

2.1Headline finding

ReportedEQL 4NRF-XTECH-GENOMICS-GLOBAL-2026-BASELINE-HLT-001

In a phase 3 study of exa-cel in severe sickle cell disease, 29 of 30 evaluable patients (97%) were free of severe vaso-occlusive crises for at least 12 consecutive months.

Implication

The result supports reading ex vivo editing of blood stem cells as a working therapy for one disease. Median follow-up was 19.3 months, patients needed myeloablative conditioning, and no cancers occurred in the period reported. The FDA approved the product on 8 December 2023 for patients 12 and older¹².

What would move it

Longer follow-up, treatment counts, price negotiations and cost-effectiveness studies would each move this finding⁶⁷.

2.2Health

1. ReportedEQL 4NRF-XTECH-GENOMICS-GLOBAL-2026-BASELINE-HLT-001

   In a phase 3 study of exa-cel in severe sickle cell disease, 29 of 30 evaluable patients (97%) were free of severe vaso-occlusive crises for 12 months or more, and all 30 were free of related hospitalisation.²

2. ReportedEQL 4NRF-XTECH-GENOMICS-GLOBAL-2026-BASELINE-HLT-002

   In a phase 3 study of exa-cel in transfusion-dependent beta-thalassaemia, 32 of 35 evaluable patients (91%) reached transfusion independence for 12 months or more.³

3. ReportedEQL 3NRF-XTECH-GENOMICS-GLOBAL-2026-BASELINE-HLT-003

   A 2025 report describes one infant with carbamoyl-phosphate synthetase 1 deficiency who received a patient-specific base-editing therapy in two infusions; follow-up was 7 weeks after the first infusion and no serious adverse events occurred.⁴⁵

4. ReportedEQL 2NRF-XTECH-GENOMICS-GLOBAL-2026-BASELINE-HLT-004

   In October 2025 a patient in a phase 3 trial of an in vivo editing therapy had a life-threatening liver event, and the FDA placed two trials on hold, according to trade press reporting company disclosures.⁹³⁹

2.3Finance

1. ReportedEQL 3NRF-XTECH-GENOMICS-GLOBAL-2026-BASELINE-FIN-005

   Casgevy revenue was USD 42.9 million in the first quarter of 2026 against USD 14.2 million a year earlier, and a cost-effectiveness analysis states that gene therapy access is limited by cost and manufacturing capacity.⁶⁷

2.4Data and digital

1. ReportedEQL 4NRF-XTECH-GENOMICS-GLOBAL-2026-BASELINE-DAT-006

   The T2T-CHM13 sequence has 3.055 billion base pairs with nearly 200 million new, and the draft pangenome holds 47 phased diploid assemblies and adds 119 million base pairs of polymorphic sequence.¹¹¹²

2. ReportedEQL 4NRF-XTECH-GENOMICS-GLOBAL-2026-BASELINE-DAT-007

   UK Biobank released whole genomes for 490,640 participants and All of Us released 245,388 genomes, of which 77% are from communities under-represented in research; literature finds most studies still rest on European ancestry.^16171819

2.5Infrastructure

1. ReportedEQL 2NRF-XTECH-GENOMICS-GLOBAL-2026-BASELINE-INF-008

   Vendor pages claim more than 128 genomes per run on one sequencer and a USD 60 genome at list price on another; neither claim is independent evidence.¹⁴¹⁵⁴⁰

2.6Energy

1. ReportedEQL 3NRF-XTECH-GENOMICS-GLOBAL-2026-BASELINE-ENE-009

   A study of common analyses found biobank-scale association studies emit substantial carbon, and a software upgrade cut one tool footprint by 73%.²¹²²

2.7Trade

1. ReportedEQL 3NRF-XTECH-GENOMICS-GLOBAL-2026-BASELINE-TRD-010

   China listed Illumina as an unreliable entity in February 2025, banned its sequencer imports in March 2025 and lifted the ban on 10 November 2025; the BIOSECURE Act was enacted on 18 December 2025.³⁰³¹

2.8Governance

1. ReportedEQL 5NRF-XTECH-GENOMICS-GLOBAL-2026-BASELINE-GOV-011

   The FDA approved Casgevy and Lyfgenia on 8 December 2023, and the Third Summit organising committee judged heritable genome editing unacceptable at this time on 8 March 2023.¹²⁷²⁸

2.9Systemic

1. Expert inputEQL 2NRF-XTECH-GENOMICS-GLOBAL-2026-BASELINE-SYS-012

   The leading compound pathway for 2027 testing is individualised editing moving faster than the payment, manufacturing and oversight systems around it. § scenario

Notes

Numbers are the edition’s reference numbers, so a note reads the same in every chapter. The full list, with every source and its licence, is in Annex C. Annex C, references

1. 2Frangoul, H. et al., Exagamglogene Autotemcel for Severe Sickle Cell Disease, New England Journal of Medicine 2024 (abstract read through the Europe PMC record; 44 treated, 30 evaluable, 29 free of crises for 12 months or more). Massachusetts Medical Society, Waltham. Observation year 2024. Accessed 2026-11-03.back
2. 1US Food and Drug Administration (ed.), FDA approves first gene therapies to treat patients with sickle cell disease (press announcement, 8 December 2023; Casgevy uses CRISPR/Cas9, Lyfgenia a lentiviral vector; patients 12 years and older). FDA, Silver Spring. Observation year 2023. Accessed 2026-11-03.back
3. 6Vertex Pharmaceuticals (ed.), Vertex Reports First Quarter 2026 Financial Results (company press release read through a wire page; Casgevy revenue USD 42.9 million against USD 14.2 million; pediatric submission completed; company statement, weak evidence). Vertex, Boston. Observation year 2026. Accessed 2026-11-03.back
4. 7Chetlapalli, K. et al., Haploidentical transplant, gene therapy, and standard care in sickle cell disease: a cost-effectiveness analysis, Blood 2026 (abstract read through the Europe PMC record; gene therapy access limited by cost and manufacturing capacity). American Society of Hematology, Washington. Observation year 2026. Accessed 2026-11-03.back
5. 3Locatelli, F. et al., Exagamglogene Autotemcel for Transfusion-Dependent beta-Thalassemia, New England Journal of Medicine 2024 (abstract read through the Europe PMC record; 52 treated, 35 evaluable, 32 transfusion independent). Massachusetts Medical Society, Waltham. Observation year 2024. Accessed 2026-11-03.back
6. 4Musunuru, K. et al., Patient-Specific In Vivo Gene Editing to Treat a Rare Genetic Disease, New England Journal of Medicine 2025 (abstract read through the Europe PMC record; one infant, two infusions at about 7 and 8 months of age). Massachusetts Medical Society, Waltham. Observation year 2025. Accessed 2026-11-03.back
7. 5Clinical Trials Arena (ed.), FDA unveils new pathway to usher bespoke therapies to market (trade press, 13 November 2025; describes the plausible mechanism pathway announced in a journal article by the FDA Commissioner and the CBER Director; secondary report, weak evidence). Clinical Trials Arena, London. Observation year 2025. Accessed 2026-11-03.back
8. 9BioSpace (ed.), Life-threatening liver toxicity triggers FDA freeze on two Intellia gene therapy studies (trade press, 30 October 2025; relays company disclosures; secondary report, weak evidence). BioSpace, Boston. Observation year 2025. Accessed 2026-11-03.back
9. 39UNVERIFIED, not opened: Intellia Therapeutics and trade press on the lifting of the 2025 clinical holds on the MAGNITUDE trials, taken from search-result summaries that differ on dates. Observation year 2026. Accessed 2026-11-03.back
10. 11Nurk, S. et al., The complete sequence of a human genome, Science 2022 (abstract read through the Europe PMC record; 3.055 billion base pairs; nearly 200 million base pairs of new sequence). American Association for the Advancement of Science, Washington. Observation year 2022. Accessed 2026-11-03.back
11. 12Liao, W.-W. et al. (Human Pangenome Reference Consortium), A draft human pangenome reference, Nature 2023 (abstract read through the Europe PMC record; 47 phased diploid assemblies; 119 million base pairs added). Springer Nature, London. Observation year 2023. Accessed 2026-11-03.back
12. 16UK Biobank Whole-Genome Sequencing Consortium, Whole-genome sequencing of 490,640 UK Biobank participants, Nature 2025 (abstract read through the Europe PMC record). Springer Nature, London. Observation year 2025. Accessed 2026-11-03.back
13. 17All of Us Research Program Genomics Investigators, Genomic data in the All of Us Research Program, Nature 2024 (abstract read through the Europe PMC record; 245,388 genomes; 77% from communities under-represented in research). Springer Nature, London. Observation year 2024. Accessed 2026-11-03.back
14. 18Fatumo, S. et al., A roadmap to increase diversity in genomic studies, Nature Medicine 2022 (abstract read through the Europe PMC record). Springer Nature, London. Observation year 2022. Accessed 2026-11-03.back
15. 19Sirugo, G., Williams, S.M. and Tishkoff, S.A., The Missing Diversity in Human Genetic Studies, Cell 2019 (abstract read through the Europe PMC record). Cell Press, Cambridge. Observation year 2019. Accessed 2026-11-03.back
16. 14Illumina (ed.), NovaSeq X Series product page (vendor claims: 16 to 21 Tb per run for NovaSeq X Plus, more than 128 genomes per run, run time about 14 to 48 hours; vendor evidence, weak). Illumina, San Diego. Observation year 2026. Accessed 2026-11-03.back
17. 15Ultima Genomics (ed.), germline genetics product page (vendor claim of a USD 60 genome at list price over 4 wafers on the UG200 series; the browser title reads USD 80; vendor evidence, weak). Ultima Genomics, Newark. Observation year 2026. Accessed 2026-11-03.back
18. 40UNVERIFIED, not opened: Ultima Genomics (ed.), UG 100 Solaris launch announcement of 24 February 2025 (USD 80 genome at list price), taken from search-result summaries; vendor evidence, weak. Ultima Genomics, Newark. Observation year 2025. Accessed 2026-11-03.back
19. 21Grealey, J. et al., The Carbon Footprint of Bioinformatics, Molecular Biology and Evolution 2022 (abstract read through the Europe PMC record; a software upgrade cut one tool footprint by 73%). Oxford University Press, Oxford. Observation year 2022. Accessed 2026-11-03.back
20. 22Lannelongue, L., Grealey, J. and Inouye, M., Green Algorithms: Quantifying the Carbon Footprint of Computation, Advanced Science 2021 (abstract read through the Europe PMC record). Wiley, Weinheim. Observation year 2021. Accessed 2026-11-03.back
21. 30Latham and Watkins (ed.), BIOSECURE Act becomes law, limiting grants with biotechnology companies of concern (law-firm summary; enacted 18 December 2025 in the FY2026 NDAA; OMB list due by 18 December 2026; secondary source of a statute). Latham and Watkins, Los Angeles. Observation year 2025. Accessed 2026-11-03.back
22. 31MedTech Dive (ed.), China to lift Illumina export ban (trade press, November 2025; listing in February 2025, import ban in March 2025, lift on 10 November 2025, instrument sales in China down 54% in the third quarter; secondary report, weak evidence). Industry Dive, Washington. Observation year 2025. Accessed 2026-11-03.back
23. 27World Health Organization (ed.), Human genome editing: a framework for governance (technical document, 12 July 2021; companion recommendations published separately and not read). WHO, Geneva. Observation year 2021. Accessed 2026-11-03.back
24. 28Royal Society (ed.), Statement from the Organising Committee of the Third International Summit on Human Genome Editing (8 March 2023; convened by the Royal Society, the Academy of Medical Sciences, the US National Academies and The World Academy of Sciences). Royal Society, London. Observation year 2023. Accessed 2026-11-03.back

3.1Where each system stood at evidence close

3.2Domain posture

Each of the twelve coupled domains is read through genomics, in words, not scored. The coupling column names the dependency that carries genomics risk into each domain.

3.3Sector screens

All sixteen sectors are screened for their dependence on genomics, on the same grammar as every national edition. The evidence column describes coverage of the baseline evidence, not the performance of the sector.

Notes

Numbers are the edition’s reference numbers, so a note reads the same in every chapter. The full list, with every source and its licence, is in Annex C. Annex C, references

1. 2Frangoul, H. et al., Exagamglogene Autotemcel for Severe Sickle Cell Disease, New England Journal of Medicine 2024 (abstract read through the Europe PMC record; 44 treated, 30 evaluable, 29 free of crises for 12 months or more). Massachusetts Medical Society, Waltham. Observation year 2024. Accessed 2026-11-03.back
2. 11Nurk, S. et al., The complete sequence of a human genome, Science 2022 (abstract read through the Europe PMC record; 3.055 billion base pairs; nearly 200 million base pairs of new sequence). American Association for the Advancement of Science, Washington. Observation year 2022. Accessed 2026-11-03.back
3. 16UK Biobank Whole-Genome Sequencing Consortium, Whole-genome sequencing of 490,640 UK Biobank participants, Nature 2025 (abstract read through the Europe PMC record). Springer Nature, London. Observation year 2025. Accessed 2026-11-03.back
4. 6Vertex Pharmaceuticals (ed.), Vertex Reports First Quarter 2026 Financial Results (company press release read through a wire page; Casgevy revenue USD 42.9 million against USD 14.2 million; pediatric submission completed; company statement, weak evidence). Vertex, Boston. Observation year 2026. Accessed 2026-11-03.back
5. 14Illumina (ed.), NovaSeq X Series product page (vendor claims: 16 to 21 Tb per run for NovaSeq X Plus, more than 128 genomes per run, run time about 14 to 48 hours; vendor evidence, weak). Illumina, San Diego. Observation year 2026. Accessed 2026-11-03.back
6. 31MedTech Dive (ed.), China to lift Illumina export ban (trade press, November 2025; listing in February 2025, import ban in March 2025, lift on 10 November 2025, instrument sales in China down 54% in the third quarter; secondary report, weak evidence). Industry Dive, Washington. Observation year 2025. Accessed 2026-11-03.back
7. 21Grealey, J. et al., The Carbon Footprint of Bioinformatics, Molecular Biology and Evolution 2022 (abstract read through the Europe PMC record; a software upgrade cut one tool footprint by 73%). Oxford University Press, Oxford. Observation year 2022. Accessed 2026-11-03.back
8. 29UK Parliament (ed.), Genetic Technology (Precision Breeding) Act 2023, 2023 c. 6 (contents page read; section texts not read). UK Parliament, London. Observation year 2023. Accessed 2026-11-03.back
9. 36UNVERIFIED, not opened: European Parliament and Council, Regulation (EU) 2026/1388 on plants obtained by certain new genomic techniques (adopted 17 June 2026, published 26 June 2026, applies from 17 July 2028), taken from search-result summaries that differ on some dates. Official Journal of the European Union, Luxembourg. Observation year 2026. Accessed 2026-11-03.back
10. 1US Food and Drug Administration (ed.), FDA approves first gene therapies to treat patients with sickle cell disease (press announcement, 8 December 2023; Casgevy uses CRISPR/Cas9, Lyfgenia a lentiviral vector; patients 12 years and older). FDA, Silver Spring. Observation year 2023. Accessed 2026-11-03.back
11. 3Locatelli, F. et al., Exagamglogene Autotemcel for Transfusion-Dependent beta-Thalassemia, New England Journal of Medicine 2024 (abstract read through the Europe PMC record; 52 treated, 35 evaluable, 32 transfusion independent). Massachusetts Medical Society, Waltham. Observation year 2024. Accessed 2026-11-03.back
12. 8Montano-Campos, J.F. et al., Cost-effectiveness of gene therapy for sickle cell disease in Uganda: tailoring high-income evidence to Uganda context, Gene Therapy 2026 (abstract read through the Europe PMC record). Springer Nature, London. Observation year 2026. Accessed 2026-11-03.back
13. 32MedTech Dive (ed.), Anne Wojcicki bid to buy 23andMe in bankruptcy (trade press, 17 June 2025; USD 305 million bid against a USD 256 million bid; state objections; secondary report, weak evidence). Industry Dive, Washington. Observation year 2025. Accessed 2026-11-03.back
14. 38UNVERIFIED, not opened: NPR (ed.), Judge approves sale of 23andMe to a nonprofit led by its founder (30 June 2025), taken from a search-result summary; the page returned a service error. NPR, Washington. Observation year 2025. Accessed 2026-11-03.back
15. 27World Health Organization (ed.), Human genome editing: a framework for governance (technical document, 12 July 2021; companion recommendations published separately and not read). WHO, Geneva. Observation year 2021. Accessed 2026-11-03.back
16. 12Liao, W.-W. et al. (Human Pangenome Reference Consortium), A draft human pangenome reference, Nature 2023 (abstract read through the Europe PMC record; 47 phased diploid assemblies; 119 million base pairs added). Springer Nature, London. Observation year 2023. Accessed 2026-11-03.back

4.1Risk objects

Each risk is read across the chain from hazard to consequence, with its status and evidence-quality level.

1. InferredEQL 3RSK-XT05-HLT-001

   Safety events in in vivo editing

   Driver

   high-dose delivery and new targets⁹¹⁰

   Exposure

   patients in early trials

   Vulnerability

   small trials; short follow-up

   Capacity

   clinical holds, monitoring and review⁹²⁷

   Cascade

   HLT → FIN, GOV

   Horizon

   1 to 5 years

2. InferredEQL 3RSK-XT05-DAT-002

   Genetic data ownership and privacy

   Driver

   sale of a large genetic database in bankruptcy³²³⁸

   Exposure

   millions of customers

   Vulnerability

   consent and state-by-state rules; weak federal limits

   Capacity

   state privacy laws and non-discrimination law⁴⁴

   Cascade

   DAT → FIN, HLT

   Horizon

   1 to 5 years

3. InferredEQL 3RSK-XT05-TRD-003

   Sequencer and consumable supply politics

   Driver

   trade controls and procurement law³⁰³¹

   Exposure

   laboratories relying on one instrument family

   Vulnerability

   few suppliers; reagent supply not assessed

   Capacity

   new entrants and alternative platforms¹⁵

   Cascade

   TRD → INF → DAT

   Horizon

   1 to 5 years

4. InferredEQL 3RSK-XT05-GOV-004

   Uneven oversight of editing

   Driver

   differing national rules and a fast-moving bespoke pathway⁵²⁹³⁶

   Exposure

   cross-border treatment and research

   Vulnerability

   heritable-editing rules differ; some rely on soft law²⁸⁴¹⁴²

   Capacity

   WHO framework and summit statements²⁷²⁸

   Cascade

   GOV → HLT, FIN

   Horizon

   1 to 10 years

4.2Capability ladder

Existence is not readiness. Each of the fifteen capability functions is placed on the ladder by the strongest public evidence for genomics at the global level.

Notes

Numbers are the edition’s reference numbers, so a note reads the same in every chapter. The full list, with every source and its licence, is in Annex C. Annex C, references

1. 9BioSpace (ed.), Life-threatening liver toxicity triggers FDA freeze on two Intellia gene therapy studies (trade press, 30 October 2025; relays company disclosures; secondary report, weak evidence). BioSpace, Boston. Observation year 2025. Accessed 2026-11-03.back
2. 10Lek, A. et al., Death after High-Dose rAAV9 Gene Therapy in a Patient with Duchenne Muscular Dystrophy, New England Journal of Medicine 2023 (abstract read through the Europe PMC record). Massachusetts Medical Society, Waltham. Observation year 2023. Accessed 2026-11-03.back
3. 27World Health Organization (ed.), Human genome editing: a framework for governance (technical document, 12 July 2021; companion recommendations published separately and not read). WHO, Geneva. Observation year 2021. Accessed 2026-11-03.back
4. 32MedTech Dive (ed.), Anne Wojcicki bid to buy 23andMe in bankruptcy (trade press, 17 June 2025; USD 305 million bid against a USD 256 million bid; state objections; secondary report, weak evidence). Industry Dive, Washington. Observation year 2025. Accessed 2026-11-03.back
5. 38UNVERIFIED, not opened: NPR (ed.), Judge approves sale of 23andMe to a nonprofit led by its founder (30 June 2025), taken from a search-result summary; the page returned a service error. NPR, Washington. Observation year 2025. Accessed 2026-11-03.back
6. 44UNVERIFIED, not opened: Genetic Information Nondiscrimination Act of 2008, Public Law 110-233, United States Congress, cited from memory. Observation year 2008. Accessed 2026-11-03.back
7. 30Latham and Watkins (ed.), BIOSECURE Act becomes law, limiting grants with biotechnology companies of concern (law-firm summary; enacted 18 December 2025 in the FY2026 NDAA; OMB list due by 18 December 2026; secondary source of a statute). Latham and Watkins, Los Angeles. Observation year 2025. Accessed 2026-11-03.back
8. 31MedTech Dive (ed.), China to lift Illumina export ban (trade press, November 2025; listing in February 2025, import ban in March 2025, lift on 10 November 2025, instrument sales in China down 54% in the third quarter; secondary report, weak evidence). Industry Dive, Washington. Observation year 2025. Accessed 2026-11-03.back
9. 15Ultima Genomics (ed.), germline genetics product page (vendor claim of a USD 60 genome at list price over 4 wafers on the UG200 series; the browser title reads USD 80; vendor evidence, weak). Ultima Genomics, Newark. Observation year 2026. Accessed 2026-11-03.back
10. 5Clinical Trials Arena (ed.), FDA unveils new pathway to usher bespoke therapies to market (trade press, 13 November 2025; describes the plausible mechanism pathway announced in a journal article by the FDA Commissioner and the CBER Director; secondary report, weak evidence). Clinical Trials Arena, London. Observation year 2025. Accessed 2026-11-03.back
11. 29UK Parliament (ed.), Genetic Technology (Precision Breeding) Act 2023, 2023 c. 6 (contents page read; section texts not read). UK Parliament, London. Observation year 2023. Accessed 2026-11-03.back
12. 36UNVERIFIED, not opened: European Parliament and Council, Regulation (EU) 2026/1388 on plants obtained by certain new genomic techniques (adopted 17 June 2026, published 26 June 2026, applies from 17 July 2028), taken from search-result summaries that differ on some dates. Official Journal of the European Union, Luxembourg. Observation year 2026. Accessed 2026-11-03.back
13. 28Royal Society (ed.), Statement from the Organising Committee of the Third International Summit on Human Genome Editing (8 March 2023; convened by the Royal Society, the Academy of Medical Sciences, the US National Academies and The World Academy of Sciences). Royal Society, London. Observation year 2023. Accessed 2026-11-03.back
14. 41UNVERIFIED, not opened: Council of Europe (ed.), Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine (Oviedo Convention), 1997, cited from memory; the page returned an access error. Council of Europe, Strasbourg. Observation year 1997. Accessed 2026-11-03.back
15. 42UNVERIFIED, not opened: Lander, E.S. et al., Adopt a moratorium on heritable genome editing, Nature 567, 165 to 168, 2019, cited from memory. Observation year 2019. Accessed 2026-11-03.back
16. 34Genomics England (ed.), Generation Study: newborn genome sequencing (initiative page; 100,000 babies; more than 200 conditions; recruitment progress not stated). Genomics England, London. Observation year 2026. Accessed 2026-11-03.back
17. 1US Food and Drug Administration (ed.), FDA approves first gene therapies to treat patients with sickle cell disease (press announcement, 8 December 2023; Casgevy uses CRISPR/Cas9, Lyfgenia a lentiviral vector; patients 12 years and older). FDA, Silver Spring. Observation year 2023. Accessed 2026-11-03.back
18. 37UNVERIFIED, not opened: US Food and Drug Administration (ed.), draft guidance on the plausible mechanism framework for individualised therapies, February 2026, taken from search-result summaries. FDA, Silver Spring. Observation year 2026. Accessed 2026-11-03.back
19. 8Montano-Campos, J.F. et al., Cost-effectiveness of gene therapy for sickle cell disease in Uganda: tailoring high-income evidence to Uganda context, Gene Therapy 2026 (abstract read through the Europe PMC record). Springer Nature, London. Observation year 2026. Accessed 2026-11-03.back
20. 7Chetlapalli, K. et al., Haploidentical transplant, gene therapy, and standard care in sickle cell disease: a cost-effectiveness analysis, Blood 2026 (abstract read through the Europe PMC record; gene therapy access limited by cost and manufacturing capacity). American Society of Hematology, Washington. Observation year 2026. Accessed 2026-11-03.back
21. 11Nurk, S. et al., The complete sequence of a human genome, Science 2022 (abstract read through the Europe PMC record; 3.055 billion base pairs; nearly 200 million base pairs of new sequence). American Association for the Advancement of Science, Washington. Observation year 2022. Accessed 2026-11-03.back
22. 16UK Biobank Whole-Genome Sequencing Consortium, Whole-genome sequencing of 490,640 UK Biobank participants, Nature 2025 (abstract read through the Europe PMC record). Springer Nature, London. Observation year 2025. Accessed 2026-11-03.back
23. 17All of Us Research Program Genomics Investigators, Genomic data in the All of Us Research Program, Nature 2024 (abstract read through the Europe PMC record; 245,388 genomes; 77% from communities under-represented in research). Springer Nature, London. Observation year 2024. Accessed 2026-11-03.back
24. 33US Bureau of Labor Statistics (ed.), Occupational Outlook Handbook: Genetic Counselors (about 4,200 jobs in 2025; median pay USD 100,040 in May 2025; 10% growth projected 2025 to 2035). BLS, Washington. Observation year 2025. Accessed 2026-11-03.back
25. 2Frangoul, H. et al., Exagamglogene Autotemcel for Severe Sickle Cell Disease, New England Journal of Medicine 2024 (abstract read through the Europe PMC record; 44 treated, 30 evaluable, 29 free of crises for 12 months or more). Massachusetts Medical Society, Waltham. Observation year 2024. Accessed 2026-11-03.back
26. 12Liao, W.-W. et al. (Human Pangenome Reference Consortium), A draft human pangenome reference, Nature 2023 (abstract read through the Europe PMC record; 47 phased diploid assemblies; 119 million base pairs added). Springer Nature, London. Observation year 2023. Accessed 2026-11-03.back
27. 24Jinek, M. et al., A programmable dual-RNA-guided DNA endonuclease in adaptive bacterial immunity, Science 2012 (abstract read through the Europe PMC record). American Association for the Advancement of Science, Washington. Observation year 2012. Accessed 2026-11-03.back

5.1Assumptions

Scenario SCN-XT05-DLV-01: what is assumed, and what is held constant.

Baseline

the 2026 reference state in this edition

Drivers

bespoke editing pathways open faster than payment, manufacturing and oversight capacity grow

Analogues

the 2025 patient-specific therapy and the 2025 trial holds⁴⁵⁹

Interventions

none modelled: the specification describes the unmitigated case

Run state

narrative specification; quantified run scheduled for 2027

5.2The cascade, step by step

1. 1

   GOV → HLT

   a plausible mechanism pathway lowers the evidence needed for bespoke therapies

   2025

2. 2

   HLT → FIN

   payers face one-time prices with thin outcome data

   2026

3. 3

   INF → HLT

   manufacturing and clinic capacity limit who is treated

   2026

4. 4

   HLT → GOV

   a safety event in a bespoke or in vivo therapy triggers holds

   2025

5. 5

   TRD → INF

   trade rules change instrument and reagent supply

   2025

6. 6

   DAT → FIN

   genetic data and biobanks become assets in disputes over ownership

   2025

5.3The scenario as a table of steps

How the shock in scenario SCN-XT05-DLV-01 would travel through Genomics and Gene Editing’s coupled systems, step by step, under the assumptions the edition states.

A teaching model of a conditional scenario under the edition’s stated assumptions: not a forecast, not a prediction and not a warning. Sources: Genomics and Gene Editing 2026, scenario SCN-XT05-DLV-01 (2026); Genomics and Gene Editing 2026, references (NR-CIT-1) (2026).

Notes

Numbers are the edition’s reference numbers, so a note reads the same in every chapter. The full list, with every source and its licence, is in Annex C. Annex C, references

1. 4Musunuru, K. et al., Patient-Specific In Vivo Gene Editing to Treat a Rare Genetic Disease, New England Journal of Medicine 2025 (abstract read through the Europe PMC record; one infant, two infusions at about 7 and 8 months of age). Massachusetts Medical Society, Waltham. Observation year 2025. Accessed 2026-11-03.back
2. 5Clinical Trials Arena (ed.), FDA unveils new pathway to usher bespoke therapies to market (trade press, 13 November 2025; describes the plausible mechanism pathway announced in a journal article by the FDA Commissioner and the CBER Director; secondary report, weak evidence). Clinical Trials Arena, London. Observation year 2025. Accessed 2026-11-03.back
3. 9BioSpace (ed.), Life-threatening liver toxicity triggers FDA freeze on two Intellia gene therapy studies (trade press, 30 October 2025; relays company disclosures; secondary report, weak evidence). BioSpace, Boston. Observation year 2025. Accessed 2026-11-03.back

6.1The other desks’ editions of this subject

Federation: each desk writes its own edition for the subjects in its remit. Until a desk releases, its edition shows its frame and the reading this edition printed for it.

6.2Three lenses

One edition, read by each steward. The lens of this site comes first.

6.3Standards, Academy and steward contributions

How the Nexus Standards drafts, the Risk Academy and the three stewards feed each quarterly edition for genomics. The standards are a preparatory working draft (2026) and are cited as drafts, never as adopted standards.

6.4GCRI reading: the model card

GCRI’s reading of this edition is its model card: what the national model is, what it computes and where it stops. It is printed in full in Annex A, with the methods it belongs to. Annex A, methodology

6.5Global Risks Forum reading: editorial essays

Four signed essays by the Reports editorial team set out the positions this edition takes. They are interpretation, labelled as such; the evidence they draw on is in the findings register.

6.6Global Risks Alliance reading: 2027 genomics readiness pack

The registers that open the 2027 global cycle. At baseline each is initialised from this edition.

Publication dispositions

• Publish
• Hold
• Needs evidence
• Restricted
• Superseded

6.7Nexus Standards reading: standards and regulatory watch

Instruments and published guidance that shape the systems in this edition, by status on the retrieval date. The edition assesses no one’s compliance.

• IN FORCE
• PUBLISHED
• DRAFT
• PUBLISHED · VOLUNTARY

6.8Risk Academy reading: literature and evidence review, science and assessments

The review behind this edition covers genomics assessments, peer-reviewed science and the institutional reports that bind its findings. Systematic reviews for each agenda item begin in 2027.

Review protocol

Question

What does the published evidence establish about genomics and gene editing as infrastructure and its couplings?

Sources searched

peer-reviewed journals and preprints; regulators and international bodies; statutes and statements; market, vendor and trade-press reports

Window

releases available at evidence close, 30 September 2026

Selection

sources that bind or contextualise a finding in this edition

Next step

systematic reviews for agenda items 01 to 05 in 2027

Notes

Numbers are the edition’s reference numbers, so a note reads the same in every chapter. The full list, with every source and its licence, is in Annex C. Annex C, references

1. 6Vertex Pharmaceuticals (ed.), Vertex Reports First Quarter 2026 Financial Results (company press release read through a wire page; Casgevy revenue USD 42.9 million against USD 14.2 million; pediatric submission completed; company statement, weak evidence). Vertex, Boston. Observation year 2026. Accessed 2026-11-03.back
2. 7Chetlapalli, K. et al., Haploidentical transplant, gene therapy, and standard care in sickle cell disease: a cost-effectiveness analysis, Blood 2026 (abstract read through the Europe PMC record; gene therapy access limited by cost and manufacturing capacity). American Society of Hematology, Washington. Observation year 2026. Accessed 2026-11-03.back
3. 1US Food and Drug Administration (ed.), FDA approves first gene therapies to treat patients with sickle cell disease (press announcement, 8 December 2023; Casgevy uses CRISPR/Cas9, Lyfgenia a lentiviral vector; patients 12 years and older). FDA, Silver Spring. Observation year 2023. Accessed 2026-11-03.back
4. 5Clinical Trials Arena (ed.), FDA unveils new pathway to usher bespoke therapies to market (trade press, 13 November 2025; describes the plausible mechanism pathway announced in a journal article by the FDA Commissioner and the CBER Director; secondary report, weak evidence). Clinical Trials Arena, London. Observation year 2025. Accessed 2026-11-03.back
5. 37UNVERIFIED, not opened: US Food and Drug Administration (ed.), draft guidance on the plausible mechanism framework for individualised therapies, February 2026, taken from search-result summaries. FDA, Silver Spring. Observation year 2026. Accessed 2026-11-03.back
6. 27World Health Organization (ed.), Human genome editing: a framework for governance (technical document, 12 July 2021; companion recommendations published separately and not read). WHO, Geneva. Observation year 2021. Accessed 2026-11-03.back
7. 28Royal Society (ed.), Statement from the Organising Committee of the Third International Summit on Human Genome Editing (8 March 2023; convened by the Royal Society, the Academy of Medical Sciences, the US National Academies and The World Academy of Sciences). Royal Society, London. Observation year 2023. Accessed 2026-11-03.back
8. 29UK Parliament (ed.), Genetic Technology (Precision Breeding) Act 2023, 2023 c. 6 (contents page read; section texts not read). UK Parliament, London. Observation year 2023. Accessed 2026-11-03.back
9. 36UNVERIFIED, not opened: European Parliament and Council, Regulation (EU) 2026/1388 on plants obtained by certain new genomic techniques (adopted 17 June 2026, published 26 June 2026, applies from 17 July 2028), taken from search-result summaries that differ on some dates. Official Journal of the European Union, Luxembourg. Observation year 2026. Accessed 2026-11-03.back
10. 30Latham and Watkins (ed.), BIOSECURE Act becomes law, limiting grants with biotechnology companies of concern (law-firm summary; enacted 18 December 2025 in the FY2026 NDAA; OMB list due by 18 December 2026; secondary source of a statute). Latham and Watkins, Los Angeles. Observation year 2025. Accessed 2026-11-03.back
11. 41UNVERIFIED, not opened: Council of Europe (ed.), Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine (Oviedo Convention), 1997, cited from memory; the page returned an access error. Council of Europe, Strasbourg. Observation year 1997. Accessed 2026-11-03.back
12. 44UNVERIFIED, not opened: Genetic Information Nondiscrimination Act of 2008, Public Law 110-233, United States Congress, cited from memory. Observation year 2008. Accessed 2026-11-03.back
13. 42UNVERIFIED, not opened: Lander, E.S. et al., Adopt a moratorium on heritable genome editing, Nature 567, 165 to 168, 2019, cited from memory. Observation year 2019. Accessed 2026-11-03.back
14. 2Frangoul, H. et al., Exagamglogene Autotemcel for Severe Sickle Cell Disease, New England Journal of Medicine 2024 (abstract read through the Europe PMC record; 44 treated, 30 evaluable, 29 free of crises for 12 months or more). Massachusetts Medical Society, Waltham. Observation year 2024. Accessed 2026-11-03.back
15. 3Locatelli, F. et al., Exagamglogene Autotemcel for Transfusion-Dependent beta-Thalassemia, New England Journal of Medicine 2024 (abstract read through the Europe PMC record; 52 treated, 35 evaluable, 32 transfusion independent). Massachusetts Medical Society, Waltham. Observation year 2024. Accessed 2026-11-03.back
16. 4Musunuru, K. et al., Patient-Specific In Vivo Gene Editing to Treat a Rare Genetic Disease, New England Journal of Medicine 2025 (abstract read through the Europe PMC record; one infant, two infusions at about 7 and 8 months of age). Massachusetts Medical Society, Waltham. Observation year 2025. Accessed 2026-11-03.back
17. 10Lek, A. et al., Death after High-Dose rAAV9 Gene Therapy in a Patient with Duchenne Muscular Dystrophy, New England Journal of Medicine 2023 (abstract read through the Europe PMC record). Massachusetts Medical Society, Waltham. Observation year 2023. Accessed 2026-11-03.back
18. 11Nurk, S. et al., The complete sequence of a human genome, Science 2022 (abstract read through the Europe PMC record; 3.055 billion base pairs; nearly 200 million base pairs of new sequence). American Association for the Advancement of Science, Washington. Observation year 2022. Accessed 2026-11-03.back
19. 12Liao, W.-W. et al. (Human Pangenome Reference Consortium), A draft human pangenome reference, Nature 2023 (abstract read through the Europe PMC record; 47 phased diploid assemblies; 119 million base pairs added). Springer Nature, London. Observation year 2023. Accessed 2026-11-03.back
20. 24Jinek, M. et al., A programmable dual-RNA-guided DNA endonuclease in adaptive bacterial immunity, Science 2012 (abstract read through the Europe PMC record). American Association for the Advancement of Science, Washington. Observation year 2012. Accessed 2026-11-03.back
21. 25Komor, A.C. et al., Programmable editing of a target base in genomic DNA without double-stranded DNA cleavage, Nature 2016 (abstract read through the Europe PMC record). Springer Nature, London. Observation year 2016. Accessed 2026-11-03.back
22. 26Anzalone, A.V. et al., Search-and-replace genome editing without double-strand breaks or donor DNA, Nature 2019 (abstract read through the Europe PMC record). Springer Nature, London. Observation year 2019. Accessed 2026-11-03.back
23. 16UK Biobank Whole-Genome Sequencing Consortium, Whole-genome sequencing of 490,640 UK Biobank participants, Nature 2025 (abstract read through the Europe PMC record). Springer Nature, London. Observation year 2025. Accessed 2026-11-03.back
24. 17All of Us Research Program Genomics Investigators, Genomic data in the All of Us Research Program, Nature 2024 (abstract read through the Europe PMC record; 245,388 genomes; 77% from communities under-represented in research). Springer Nature, London. Observation year 2024. Accessed 2026-11-03.back
25. 18Fatumo, S. et al., A roadmap to increase diversity in genomic studies, Nature Medicine 2022 (abstract read through the Europe PMC record). Springer Nature, London. Observation year 2022. Accessed 2026-11-03.back
26. 19Sirugo, G., Williams, S.M. and Tishkoff, S.A., The Missing Diversity in Human Genetic Studies, Cell 2019 (abstract read through the Europe PMC record). Cell Press, Cambridge. Observation year 2019. Accessed 2026-11-03.back
27. 20Stephens, Z.D. et al., Big Data: Astronomical or Genomical?, PLOS Biology 2015 (abstract read through the Europe PMC record). Public Library of Science, San Francisco. Observation year 2015. Accessed 2026-11-03.back
28. 43UNVERIFIED, not opened: International Human Genome Sequencing Consortium, Initial sequencing and analysis of the human genome, Nature 409, 860 to 921, 2001, cited from memory. Observation year 2001. Accessed 2026-11-03.back
29. 21Grealey, J. et al., The Carbon Footprint of Bioinformatics, Molecular Biology and Evolution 2022 (abstract read through the Europe PMC record; a software upgrade cut one tool footprint by 73%). Oxford University Press, Oxford. Observation year 2022. Accessed 2026-11-03.back
30. 14Illumina (ed.), NovaSeq X Series product page (vendor claims: 16 to 21 Tb per run for NovaSeq X Plus, more than 128 genomes per run, run time about 14 to 48 hours; vendor evidence, weak). Illumina, San Diego. Observation year 2026. Accessed 2026-11-03.back
31. 15Ultima Genomics (ed.), germline genetics product page (vendor claim of a USD 60 genome at list price over 4 wafers on the UG200 series; the browser title reads USD 80; vendor evidence, weak). Ultima Genomics, Newark. Observation year 2026. Accessed 2026-11-03.back
32. 33US Bureau of Labor Statistics (ed.), Occupational Outlook Handbook: Genetic Counselors (about 4,200 jobs in 2025; median pay USD 100,040 in May 2025; 10% growth projected 2025 to 2035). BLS, Washington. Observation year 2025. Accessed 2026-11-03.back
33. 34Genomics England (ed.), Generation Study: newborn genome sequencing (initiative page; 100,000 babies; more than 200 conditions; recruitment progress not stated). Genomics England, London. Observation year 2026. Accessed 2026-11-03.back
34. 23Brixi, G. et al., Genome modelling and design across all domains of life with Evo 2, bioRxiv preprint 2025 (abstract read through the Europe PMC record; trained on 9.3 trillion base pairs; not peer reviewed at the time of reading). Cold Spring Harbor Laboratory, New York. Observation year 2025. Accessed 2026-11-03.back
35. 9BioSpace (ed.), Life-threatening liver toxicity triggers FDA freeze on two Intellia gene therapy studies (trade press, 30 October 2025; relays company disclosures; secondary report, weak evidence). BioSpace, Boston. Observation year 2025. Accessed 2026-11-03.back
36. 22Lannelongue, L., Grealey, J. and Inouye, M., Green Algorithms: Quantifying the Carbon Footprint of Computation, Advanced Science 2021 (abstract read through the Europe PMC record). Wiley, Weinheim. Observation year 2021. Accessed 2026-11-03.back

7.1Questions for the operational series

1. Q-01

   How many patients are treated with editing therapies, at what price, and where are the access gaps?

   INI-XT05-DLV-01 · delivery and access; first output: treatment and price register.

2. Q-02

   What energy, cooling and cold-chain load do sequencing and cell therapies carry?

   INI-XT05-ENE-02 · footprint of genomics; first output: footprint estimates by activity.

3. Q-03

   What do sequencing and therapy costs look like on an independent basis?

   INI-XT05-CST-03 · cost on a common basis; first output: cost table.

4. Q-04

   Which instruments, consumables and reagents are single points of failure?

   INI-XT05-SUP-04 · sequencer supply; first output: dependence map.

5. Q-05

   How balanced are genome datasets by ancestry on a common basis?

   INI-XT05-DIV-05 · dataset balance; first output: ancestry table.

6. Q-06

   Which national rules cover genetic data, somatic editing and heritable editing?

   To be admitted in 2027; first output: rule overlay.

7. Q-07

   What workforce exists for genetic counselling, laboratory work and bioinformatics?

   To be admitted in 2027; first output: scoping note.

8. Q-08

   Which readiness capabilities have been tested, and which are only planned?

   Readiness capability register; first output: rung evidence for 15 functions.

7.2Portfolio proposed for the Q1 2027 alignment

Five initiatives and one Universe mission candidate are proposed for the 2027 genomics portfolio. They are programme objects: no partner, funder or member is attached to them in this edition.

7.3The pathway

The genomics edition reads national readiness chapters, the coupled sector reports on health and data, and the global edition through one governed evidence graph. At baseline the federation is designed; the global energy and lifeline editions are drafted. This page states what exists today and what comes next.

1. 01

   National readiness chapters

   genomic medicine and data-protection readiness in each national edition

   IN PREPARATION · national baselines

2. 02

   Sector couplings

   GS-04 health · XT-04 biotechnology · XT-10 cryptography

   GS-04 DRAFTED · sector baselines

3. 03

   Technology system model

   sequencing, data, therapies, trade, workforce, governance

   v0 SPECIFIED · v1 with federation evidence

4. 04

   Strategic links

   SR-02 lifeline systems · SR-13 strategic technology

   PLANNED · strategic baselines

5. 05

   Universe

   annual proving environment

   CANDIDATE MISSION · mandate in 2027

6. 06

   XT-05 report

   this series

   BASELINE DRAFT · 2027 annual edition

7. 07

   Evidence and correction

   one graph, many projections

   OPEN · first correction cycle in 2027

7.4Universe 2027: evidence pack for the genomics candidate mission

1. 01

   Mandate

2. 02

   Core Build · 1 month

3. 03

   Action · 1 week

4. 04

   Evidence seal

5. 05

   Portfolio correction

6. 06

   Next mandate

Mission

ID

MSN-XT05-2027-01 · Delivery pathway Universe mission

Role spine

Leadership sponsor · Institutional anchor · Mission lead: drawn from national pathways

Receiving actors

to be identified with the mandate

7.5Handoffs and routing

Where the baseline’s findings go next. A handoff routes a finding for awareness, review or work; it transfers no authority.

7.6Feeds and signal register

Escalation routes

• none · keep monitoring
• research question
• project
• risk object
• annual publication
• signal report

Notes

Numbers are the edition’s reference numbers, so a note reads the same in every chapter. The full list, with every source and its licence, is in Annex C. Annex C, references

1. 2Frangoul, H. et al., Exagamglogene Autotemcel for Severe Sickle Cell Disease, New England Journal of Medicine 2024 (abstract read through the Europe PMC record; 44 treated, 30 evaluable, 29 free of crises for 12 months or more). Massachusetts Medical Society, Waltham. Observation year 2024. Accessed 2026-11-03.back
2. 3Locatelli, F. et al., Exagamglogene Autotemcel for Transfusion-Dependent beta-Thalassemia, New England Journal of Medicine 2024 (abstract read through the Europe PMC record; 52 treated, 35 evaluable, 32 transfusion independent). Massachusetts Medical Society, Waltham. Observation year 2024. Accessed 2026-11-03.back
3. 9BioSpace (ed.), Life-threatening liver toxicity triggers FDA freeze on two Intellia gene therapy studies (trade press, 30 October 2025; relays company disclosures; secondary report, weak evidence). BioSpace, Boston. Observation year 2025. Accessed 2026-11-03.back
4. 14Illumina (ed.), NovaSeq X Series product page (vendor claims: 16 to 21 Tb per run for NovaSeq X Plus, more than 128 genomes per run, run time about 14 to 48 hours; vendor evidence, weak). Illumina, San Diego. Observation year 2026. Accessed 2026-11-03.back
5. 15Ultima Genomics (ed.), germline genetics product page (vendor claim of a USD 60 genome at list price over 4 wafers on the UG200 series; the browser title reads USD 80; vendor evidence, weak). Ultima Genomics, Newark. Observation year 2026. Accessed 2026-11-03.back

8.1Sequencing hardware, data and compute

Sequencers, reference genomes and biobanks carry the data base. Evidence is strongest where peer review exists, and weakest where claims rest on vendor pages.

Related editions

• GLB Global Systems
• GS-04 Health
• XT-04 Biotechnology
• XT-10 Cybersecurity and Advanced Cryptography
• SR-04 Critical Minerals and Strategic Materials
• XT-01 Artificial Intelligence and Agentic Systems

8.2Compute, energy and cold chains

Genomics is a big-data science, and compute has a carbon footprint. The energy and cooling use of sequencing and of cell-therapy cold chains is not published.

Related editions

• GLB Global Systems
• GS-04 Health
• XT-04 Biotechnology
• XT-10 Cybersecurity and Advanced Cryptography
• SR-04 Critical Minerals and Strategic Materials
• XT-01 Artificial Intelligence and Agentic Systems

8.3Instruments, consumables and supply chain

Sequencing depends on instruments and consumables from a few suppliers, and trade rules changed supply in 2025.

Related editions

• GLB Global Systems
• GS-04 Health
• XT-04 Biotechnology
• XT-10 Cybersecurity and Advanced Cryptography
• SR-04 Critical Minerals and Strategic Materials
• XT-01 Artificial Intelligence and Agentic Systems

8.4Economy, access and workforce

Therapy revenue is rising from a small base, and access is limited by cost and manufacturing capacity. Workforce figures are thin.

Related editions

• GLB Global Systems
• GS-04 Health
• XT-04 Biotechnology
• XT-10 Cybersecurity and Advanced Cryptography
• SR-04 Critical Minerals and Strategic Materials
• XT-01 Artificial Intelligence and Agentic Systems

8.5Security, data protection and governance watch

Rules decide what reaches patients and who holds genetic data. Heritable editing is judged unacceptable at this time, and approvals for bespoke therapies are being redrawn.

Related editions

• GLB Global Systems
• GS-04 Health
• XT-04 Biotechnology
• XT-10 Cybersecurity and Advanced Cryptography
• SR-04 Critical Minerals and Strategic Materials
• XT-01 Artificial Intelligence and Agentic Systems

Notes

Numbers are the edition’s reference numbers, so a note reads the same in every chapter. The full list, with every source and its licence, is in Annex C. Annex C, references

1. 11Nurk, S. et al., The complete sequence of a human genome, Science 2022 (abstract read through the Europe PMC record; 3.055 billion base pairs; nearly 200 million base pairs of new sequence). American Association for the Advancement of Science, Washington. Observation year 2022. Accessed 2026-11-03.back
2. 16UK Biobank Whole-Genome Sequencing Consortium, Whole-genome sequencing of 490,640 UK Biobank participants, Nature 2025 (abstract read through the Europe PMC record). Springer Nature, London. Observation year 2025. Accessed 2026-11-03.back
3. 14Illumina (ed.), NovaSeq X Series product page (vendor claims: 16 to 21 Tb per run for NovaSeq X Plus, more than 128 genomes per run, run time about 14 to 48 hours; vendor evidence, weak). Illumina, San Diego. Observation year 2026. Accessed 2026-11-03.back
4. 12Liao, W.-W. et al. (Human Pangenome Reference Consortium), A draft human pangenome reference, Nature 2023 (abstract read through the Europe PMC record; 47 phased diploid assemblies; 119 million base pairs added). Springer Nature, London. Observation year 2023. Accessed 2026-11-03.back
5. 17All of Us Research Program Genomics Investigators, Genomic data in the All of Us Research Program, Nature 2024 (abstract read through the Europe PMC record; 245,388 genomes; 77% from communities under-represented in research). Springer Nature, London. Observation year 2024. Accessed 2026-11-03.back
6. 15Ultima Genomics (ed.), germline genetics product page (vendor claim of a USD 60 genome at list price over 4 wafers on the UG200 series; the browser title reads USD 80; vendor evidence, weak). Ultima Genomics, Newark. Observation year 2026. Accessed 2026-11-03.back
7. 23Brixi, G. et al., Genome modelling and design across all domains of life with Evo 2, bioRxiv preprint 2025 (abstract read through the Europe PMC record; trained on 9.3 trillion base pairs; not peer reviewed at the time of reading). Cold Spring Harbor Laboratory, New York. Observation year 2025. Accessed 2026-11-03.back
8. 21Grealey, J. et al., The Carbon Footprint of Bioinformatics, Molecular Biology and Evolution 2022 (abstract read through the Europe PMC record; a software upgrade cut one tool footprint by 73%). Oxford University Press, Oxford. Observation year 2022. Accessed 2026-11-03.back
9. 20Stephens, Z.D. et al., Big Data: Astronomical or Genomical?, PLOS Biology 2015 (abstract read through the Europe PMC record). Public Library of Science, San Francisco. Observation year 2015. Accessed 2026-11-03.back
10. 22Lannelongue, L., Grealey, J. and Inouye, M., Green Algorithms: Quantifying the Carbon Footprint of Computation, Advanced Science 2021 (abstract read through the Europe PMC record). Wiley, Weinheim. Observation year 2021. Accessed 2026-11-03.back
11. 1US Food and Drug Administration (ed.), FDA approves first gene therapies to treat patients with sickle cell disease (press announcement, 8 December 2023; Casgevy uses CRISPR/Cas9, Lyfgenia a lentiviral vector; patients 12 years and older). FDA, Silver Spring. Observation year 2023. Accessed 2026-11-03.back
12. 6Vertex Pharmaceuticals (ed.), Vertex Reports First Quarter 2026 Financial Results (company press release read through a wire page; Casgevy revenue USD 42.9 million against USD 14.2 million; pediatric submission completed; company statement, weak evidence). Vertex, Boston. Observation year 2026. Accessed 2026-11-03.back
13. 31MedTech Dive (ed.), China to lift Illumina export ban (trade press, November 2025; listing in February 2025, import ban in March 2025, lift on 10 November 2025, instrument sales in China down 54% in the third quarter; secondary report, weak evidence). Industry Dive, Washington. Observation year 2025. Accessed 2026-11-03.back
14. 30Latham and Watkins (ed.), BIOSECURE Act becomes law, limiting grants with biotechnology companies of concern (law-firm summary; enacted 18 December 2025 in the FY2026 NDAA; OMB list due by 18 December 2026; secondary source of a statute). Latham and Watkins, Los Angeles. Observation year 2025. Accessed 2026-11-03.back
15. 33US Bureau of Labor Statistics (ed.), Occupational Outlook Handbook: Genetic Counselors (about 4,200 jobs in 2025; median pay USD 100,040 in May 2025; 10% growth projected 2025 to 2035). BLS, Washington. Observation year 2025. Accessed 2026-11-03.back
16. 7Chetlapalli, K. et al., Haploidentical transplant, gene therapy, and standard care in sickle cell disease: a cost-effectiveness analysis, Blood 2026 (abstract read through the Europe PMC record; gene therapy access limited by cost and manufacturing capacity). American Society of Hematology, Washington. Observation year 2026. Accessed 2026-11-03.back
17. 8Montano-Campos, J.F. et al., Cost-effectiveness of gene therapy for sickle cell disease in Uganda: tailoring high-income evidence to Uganda context, Gene Therapy 2026 (abstract read through the Europe PMC record). Springer Nature, London. Observation year 2026. Accessed 2026-11-03.back
18. 34Genomics England (ed.), Generation Study: newborn genome sequencing (initiative page; 100,000 babies; more than 200 conditions; recruitment progress not stated). Genomics England, London. Observation year 2026. Accessed 2026-11-03.back
19. 27World Health Organization (ed.), Human genome editing: a framework for governance (technical document, 12 July 2021; companion recommendations published separately and not read). WHO, Geneva. Observation year 2021. Accessed 2026-11-03.back
20. 36UNVERIFIED, not opened: European Parliament and Council, Regulation (EU) 2026/1388 on plants obtained by certain new genomic techniques (adopted 17 June 2026, published 26 June 2026, applies from 17 July 2028), taken from search-result summaries that differ on some dates. Official Journal of the European Union, Luxembourg. Observation year 2026. Accessed 2026-11-03.back
21. 5Clinical Trials Arena (ed.), FDA unveils new pathway to usher bespoke therapies to market (trade press, 13 November 2025; describes the plausible mechanism pathway announced in a journal article by the FDA Commissioner and the CBER Director; secondary report, weak evidence). Clinical Trials Arena, London. Observation year 2025. Accessed 2026-11-03.back
22. 28Royal Society (ed.), Statement from the Organising Committee of the Third International Summit on Human Genome Editing (8 March 2023; convened by the Royal Society, the Academy of Medical Sciences, the US National Academies and The World Academy of Sciences). Royal Society, London. Observation year 2023. Accessed 2026-11-03.back
23. 32MedTech Dive (ed.), Anne Wojcicki bid to buy 23andMe in bankruptcy (trade press, 17 June 2025; USD 305 million bid against a USD 256 million bid; state objections; secondary report, weak evidence). Industry Dive, Washington. Observation year 2025. Accessed 2026-11-03.back
24. 38UNVERIFIED, not opened: NPR (ed.), Judge approves sale of 23andMe to a nonprofit led by its founder (30 June 2025), taken from a search-result summary; the page returned a service error. NPR, Washington. Observation year 2025. Accessed 2026-11-03.back
25. 29UK Parliament (ed.), Genetic Technology (Precision Breeding) Act 2023, 2023 c. 6 (contents page read; section texts not read). UK Parliament, London. Observation year 2023. Accessed 2026-11-03.back

A.1Methods

The global baseline uses published values and four simple derivations. Each is shown in full so that any reader can reproduce it.

A.2Model card, Genomics System Model v0

Model ID

MDL-XT05-GENOMICS · v0.1

Purpose

represent genomics and gene editing as infrastructure coupled to health, compute and energy, trade and supply, finance, workforce and data protection

Family

graph-based system of systems

Inputs

the cited sources of this edition; no proprietary data

Method

expert-specified coupling strengths (STRONG · MODERATE · WEAK) from assessments and analogue events

Validation

none yet, first validation against federation evidence in 2027

Uncertainty

qualitative; strengths are hypotheses, not measurements

Domain of validity

global scale; not for asset-, site- or country-level use

Reproducibility

strength table and sources published in this edition

A.3The baseline evidence cut

Every Nexus edition is published from a frozen evidence cut. The global baseline cut is documentary: it pins the exact edition of every source cited. Federation cuts begin with the first national Foundry cuts in 2027.

Cut ID

DC-XTECH-GENOMICS-GLOBAL-2026-B0

Type

baseline documentary cut

Resolution policy

pinned · as of 30 September 2026

Sources pinned

44 cited sources, each at the edition and access date in the references

Model runs

none at baseline, analytical values are stated with their method

Digest

computed at freeze and recorded in the publication record

Supersedes

nothing, first cut of the series

Superseded by

the 2027 genomics annual cut

Lineage

1. 01

   source edition

2. 02

   pinned citation

3. 03

   finding

4. 04

   page

5. 05

   publication record

A.4Evidence age and coverage

A 2026 global edition rests on evidence observed in many different years. This page shows each time base, so that no single year label hides older evidence.

A.5Evidence cards, two anchor sources

Evidence cards to follow in 2027

• Frangoul²: follow-up beyond the median 19.3 months
• Vertex⁶: counts of patients treated
• FDA³⁷: draft guidance text
• Official Journal³⁶: regulation text

A.6Publication acceptance record

Editorial self-check at evidence close. Every applicable item carries a disposition; the remaining items are review, approval and deposit.

A.7Status words

A.8How the edition is made, released and corrected

Every edition is built from a sealed evidence cut, reviewed under three keys, signed and deposited before any site shows it as published; corrections go to Nexus Standards as change proposals and feed the next cut.

A teaching model of the process, not a forecast and not a record of any run; dates and counts on this page come from the programme record. Sources: Reports governance at GCRI Canada (2026); Zenodo, repository of record for Reports deposits (2026).

Lifecycle, one state at a time: Draft, Computed, Evidence bound, Reviewed, Approved for release, Published, Corrected, Superseded. This edition is a draft.

A.9Glossary and abbreviations

A.10Technical annex

A.1 · indicator definition: transfusion independence

Construct

a weighted average haemoglobin level of 9 g per decilitre or higher without red-cell transfusion for at least 12 consecutive months

Unit

patients meeting the definition among evaluable patients

Method

prespecified interim analysis of an open-label single-group study

Source

New England Journal of Medicine 2024³

Uncertainty

95% confidence interval 77 to 98 for the 91% result

Known limits

interim analysis; short follow-up; no comparison arm

Notes

Numbers are the edition’s reference numbers, so a note reads the same in every chapter. The full list, with every source and its licence, is in Annex C. Annex C, references

1. 21Grealey, J. et al., The Carbon Footprint of Bioinformatics, Molecular Biology and Evolution 2022 (abstract read through the Europe PMC record; a software upgrade cut one tool footprint by 73%). Oxford University Press, Oxford. Observation year 2022. Accessed 2026-11-03.back
2. 22Lannelongue, L., Grealey, J. and Inouye, M., Green Algorithms: Quantifying the Carbon Footprint of Computation, Advanced Science 2021 (abstract read through the Europe PMC record). Wiley, Weinheim. Observation year 2021. Accessed 2026-11-03.back
3. 13National Human Genome Research Institute (ed.), The Cost of Sequencing a Human Genome (fact sheet page; method notes read; the cost values sit in graphs and a linked table that were not read; page updated 16 May 2023). NHGRI, Bethesda. Observation year 2023. Accessed 2026-11-03.back
4. 15Ultima Genomics (ed.), germline genetics product page (vendor claim of a USD 60 genome at list price over 4 wafers on the UG200 series; the browser title reads USD 80; vendor evidence, weak). Ultima Genomics, Newark. Observation year 2026. Accessed 2026-11-03.back
5. 40UNVERIFIED, not opened: Ultima Genomics (ed.), UG 100 Solaris launch announcement of 24 February 2025 (USD 80 genome at list price), taken from search-result summaries; vendor evidence, weak. Ultima Genomics, Newark. Observation year 2025. Accessed 2026-11-03.back
6. 6Vertex Pharmaceuticals (ed.), Vertex Reports First Quarter 2026 Financial Results (company press release read through a wire page; Casgevy revenue USD 42.9 million against USD 14.2 million; pediatric submission completed; company statement, weak evidence). Vertex, Boston. Observation year 2026. Accessed 2026-11-03.back
7. 35UNVERIFIED, not opened: Vertex Pharmaceuticals (ed.), full-year 2025 results (Casgevy revenue USD 115.8 million in 2025 and USD 10 million in 2024), taken from search-result summaries. Vertex, Boston. Observation year 2025. Accessed 2026-11-03.back
8. 16UK Biobank Whole-Genome Sequencing Consortium, Whole-genome sequencing of 490,640 UK Biobank participants, Nature 2025 (abstract read through the Europe PMC record). Springer Nature, London. Observation year 2025. Accessed 2026-11-03.back
9. 17All of Us Research Program Genomics Investigators, Genomic data in the All of Us Research Program, Nature 2024 (abstract read through the Europe PMC record; 245,388 genomes; 77% from communities under-represented in research). Springer Nature, London. Observation year 2024. Accessed 2026-11-03.back
10. 18Fatumo, S. et al., A roadmap to increase diversity in genomic studies, Nature Medicine 2022 (abstract read through the Europe PMC record). Springer Nature, London. Observation year 2022. Accessed 2026-11-03.back
11. 19Sirugo, G., Williams, S.M. and Tishkoff, S.A., The Missing Diversity in Human Genetic Studies, Cell 2019 (abstract read through the Europe PMC record). Cell Press, Cambridge. Observation year 2019. Accessed 2026-11-03.back
12. 31MedTech Dive (ed.), China to lift Illumina export ban (trade press, November 2025; listing in February 2025, import ban in March 2025, lift on 10 November 2025, instrument sales in China down 54% in the third quarter; secondary report, weak evidence). Industry Dive, Washington. Observation year 2025. Accessed 2026-11-03.back
13. 36UNVERIFIED, not opened: European Parliament and Council, Regulation (EU) 2026/1388 on plants obtained by certain new genomic techniques (adopted 17 June 2026, published 26 June 2026, applies from 17 July 2028), taken from search-result summaries that differ on some dates. Official Journal of the European Union, Luxembourg. Observation year 2026. Accessed 2026-11-03.back
14. 37UNVERIFIED, not opened: US Food and Drug Administration (ed.), draft guidance on the plausible mechanism framework for individualised therapies, February 2026, taken from search-result summaries. FDA, Silver Spring. Observation year 2026. Accessed 2026-11-03.back
15. 5Clinical Trials Arena (ed.), FDA unveils new pathway to usher bespoke therapies to market (trade press, 13 November 2025; describes the plausible mechanism pathway announced in a journal article by the FDA Commissioner and the CBER Director; secondary report, weak evidence). Clinical Trials Arena, London. Observation year 2025. Accessed 2026-11-03.back
16. 39UNVERIFIED, not opened: Intellia Therapeutics and trade press on the lifting of the 2025 clinical holds on the MAGNITUDE trials, taken from search-result summaries that differ on dates. Observation year 2026. Accessed 2026-11-03.back
17. 41UNVERIFIED, not opened: Council of Europe (ed.), Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine (Oviedo Convention), 1997, cited from memory; the page returned an access error. Council of Europe, Strasbourg. Observation year 1997. Accessed 2026-11-03.back
18. 33US Bureau of Labor Statistics (ed.), Occupational Outlook Handbook: Genetic Counselors (about 4,200 jobs in 2025; median pay USD 100,040 in May 2025; 10% growth projected 2025 to 2035). BLS, Washington. Observation year 2025. Accessed 2026-11-03.back
19. 2Frangoul, H. et al., Exagamglogene Autotemcel for Severe Sickle Cell Disease, New England Journal of Medicine 2024 (abstract read through the Europe PMC record; 44 treated, 30 evaluable, 29 free of crises for 12 months or more). Massachusetts Medical Society, Waltham. Observation year 2024. Accessed 2026-11-03.back
20. 11Nurk, S. et al., The complete sequence of a human genome, Science 2022 (abstract read through the Europe PMC record; 3.055 billion base pairs; nearly 200 million base pairs of new sequence). American Association for the Advancement of Science, Washington. Observation year 2022. Accessed 2026-11-03.back
21. 3Locatelli, F. et al., Exagamglogene Autotemcel for Transfusion-Dependent beta-Thalassemia, New England Journal of Medicine 2024 (abstract read through the Europe PMC record; 52 treated, 35 evaluable, 32 transfusion independent). Massachusetts Medical Society, Waltham. Observation year 2024. Accessed 2026-11-03.back

B.1The indicator set

B.2Global source register

The governed source set behind this edition. Each source keeps its authority, coverage, cadence and role; categories describe origin, not truth.

Domains bound by the register

• HLT
• DAT
• FIN
• TRD
• ENE
• INF
• GOV
• FOO
• BIO
• AIC

B.3Regional reading, genomics across ten clusters

Regional plates follow with the regional editions. This page gives the regional reading of genomics infrastructure and exposure in table form and ranks no region.

B.4Cluster card: ex vivo editing therapy chain

• cell therapy
• cold chain
• treatment centres
• single point

Systems in view

cell collection, editing, manufacture, conditioning, infusion

Defining events

approval on 8 December 2023 and a pediatric submission in 2026¹⁶

Couplings

HLT → FIN payment; INF → HLT manufacturing capacity

Capability evidence

authorised treatment centres reported by the company⁶

Gaps

patients treated; prices; cold-chain energy

Agenda items

Q-01 · Q-02

B.5How countries appear in the genomics edition

Countries enter the genomics edition through the readiness chapters of their own national editions, on one card grammar. They are read against peer distributions and thresholds, never ranked.

Editions in the 2026 Baseline programme

How to read a country card

• Each system is shown against the distribution of its peers, with thresholds where they exist
• Couplings and risk objects come from the country’s own national edition
• Capability rungs record evidence, not a judgement of institutions
• Evidence age is printed, so older national data are visible as such

B.6Licences

B.7Formats and provenance

Provenance

Edition pack

The edition’s content pack (JSON), from which the print and web editions are built

Evidence cut

DC-XTECH-GENOMICS-GLOBAL-2026-B0, closed 30 September 2026

Reproducibility

sourced values cited; analytical values reproducible from stated parameters

Self-check

14 of 23 at evidence close; a fail on any item blocks release

Review

five passes scheduled before release (in Annex C)

Publisher of record

GCRI for the Nexus Consortium

Corrections

Registry correction pathway; upheld corrections are published as notices with a new version

Notes

Numbers are the edition’s reference numbers, so a note reads the same in every chapter. The full list, with every source and its licence, is in Annex C. Annex C, references

1. 2Frangoul, H. et al., Exagamglogene Autotemcel for Severe Sickle Cell Disease, New England Journal of Medicine 2024 (abstract read through the Europe PMC record; 44 treated, 30 evaluable, 29 free of crises for 12 months or more). Massachusetts Medical Society, Waltham. Observation year 2024. Accessed 2026-11-03.back
2. 3Locatelli, F. et al., Exagamglogene Autotemcel for Transfusion-Dependent beta-Thalassemia, New England Journal of Medicine 2024 (abstract read through the Europe PMC record; 52 treated, 35 evaluable, 32 transfusion independent). Massachusetts Medical Society, Waltham. Observation year 2024. Accessed 2026-11-03.back
3. 11Nurk, S. et al., The complete sequence of a human genome, Science 2022 (abstract read through the Europe PMC record; 3.055 billion base pairs; nearly 200 million base pairs of new sequence). American Association for the Advancement of Science, Washington. Observation year 2022. Accessed 2026-11-03.back
4. 12Liao, W.-W. et al. (Human Pangenome Reference Consortium), A draft human pangenome reference, Nature 2023 (abstract read through the Europe PMC record; 47 phased diploid assemblies; 119 million base pairs added). Springer Nature, London. Observation year 2023. Accessed 2026-11-03.back
5. 16UK Biobank Whole-Genome Sequencing Consortium, Whole-genome sequencing of 490,640 UK Biobank participants, Nature 2025 (abstract read through the Europe PMC record). Springer Nature, London. Observation year 2025. Accessed 2026-11-03.back
6. 17All of Us Research Program Genomics Investigators, Genomic data in the All of Us Research Program, Nature 2024 (abstract read through the Europe PMC record; 245,388 genomes; 77% from communities under-represented in research). Springer Nature, London. Observation year 2024. Accessed 2026-11-03.back
7. 6Vertex Pharmaceuticals (ed.), Vertex Reports First Quarter 2026 Financial Results (company press release read through a wire page; Casgevy revenue USD 42.9 million against USD 14.2 million; pediatric submission completed; company statement, weak evidence). Vertex, Boston. Observation year 2026. Accessed 2026-11-03.back
8. 33US Bureau of Labor Statistics (ed.), Occupational Outlook Handbook: Genetic Counselors (about 4,200 jobs in 2025; median pay USD 100,040 in May 2025; 10% growth projected 2025 to 2035). BLS, Washington. Observation year 2025. Accessed 2026-11-03.back
9. 34Genomics England (ed.), Generation Study: newborn genome sequencing (initiative page; 100,000 babies; more than 200 conditions; recruitment progress not stated). Genomics England, London. Observation year 2026. Accessed 2026-11-03.back
10. 1US Food and Drug Administration (ed.), FDA approves first gene therapies to treat patients with sickle cell disease (press announcement, 8 December 2023; Casgevy uses CRISPR/Cas9, Lyfgenia a lentiviral vector; patients 12 years and older). FDA, Silver Spring. Observation year 2023. Accessed 2026-11-03.back
11. 21Grealey, J. et al., The Carbon Footprint of Bioinformatics, Molecular Biology and Evolution 2022 (abstract read through the Europe PMC record; a software upgrade cut one tool footprint by 73%). Oxford University Press, Oxford. Observation year 2022. Accessed 2026-11-03.back
12. 14Illumina (ed.), NovaSeq X Series product page (vendor claims: 16 to 21 Tb per run for NovaSeq X Plus, more than 128 genomes per run, run time about 14 to 48 hours; vendor evidence, weak). Illumina, San Diego. Observation year 2026. Accessed 2026-11-03.back
13. 15Ultima Genomics (ed.), germline genetics product page (vendor claim of a USD 60 genome at list price over 4 wafers on the UG200 series; the browser title reads USD 80; vendor evidence, weak). Ultima Genomics, Newark. Observation year 2026. Accessed 2026-11-03.back
14. 30Latham and Watkins (ed.), BIOSECURE Act becomes law, limiting grants with biotechnology companies of concern (law-firm summary; enacted 18 December 2025 in the FY2026 NDAA; OMB list due by 18 December 2026; secondary source of a statute). Latham and Watkins, Los Angeles. Observation year 2025. Accessed 2026-11-03.back
15. 31MedTech Dive (ed.), China to lift Illumina export ban (trade press, November 2025; listing in February 2025, import ban in March 2025, lift on 10 November 2025, instrument sales in China down 54% in the third quarter; secondary report, weak evidence). Industry Dive, Washington. Observation year 2025. Accessed 2026-11-03.back
16. 29UK Parliament (ed.), Genetic Technology (Precision Breeding) Act 2023, 2023 c. 6 (contents page read; section texts not read). UK Parliament, London. Observation year 2023. Accessed 2026-11-03.back
17. 8Montano-Campos, J.F. et al., Cost-effectiveness of gene therapy for sickle cell disease in Uganda: tailoring high-income evidence to Uganda context, Gene Therapy 2026 (abstract read through the Europe PMC record). Springer Nature, London. Observation year 2026. Accessed 2026-11-03.back

C.144 sources

NR-CIT-1, editor first. A DOI is linked where the source has one; Nexus records carry a UNI once the catalogue allocates it (NS-1).

1. 1US Food and Drug Administration (ed.), FDA approves first gene therapies to treat patients with sickle cell disease (press announcement, 8 December 2023; Casgevy uses CRISPR/Cas9, Lyfgenia a lentiviral vector; patients 12 years and older). FDA, Silver Spring. Observation year 2023. Accessed 2026-11-03. Cited in the summary, chapter 1, chapter 2, chapter 3, chapter 4, chapter 6, chapter 8
2. 2Frangoul, H. et al., Exagamglogene Autotemcel for Severe Sickle Cell Disease, New England Journal of Medicine 2024 (abstract read through the Europe PMC record; 44 treated, 30 evaluable, 29 free of crises for 12 months or more). Massachusetts Medical Society, Waltham. Observation year 2024. Accessed 2026-11-03. Cited in the summary, chapter 1, chapter 2, chapter 3, chapter 4, chapter 6, chapter 7
3. 3Locatelli, F. et al., Exagamglogene Autotemcel for Transfusion-Dependent beta-Thalassemia, New England Journal of Medicine 2024 (abstract read through the Europe PMC record; 52 treated, 35 evaluable, 32 transfusion independent). Massachusetts Medical Society, Waltham. Observation year 2024. Accessed 2026-11-03. Cited in the summary, chapter 1, chapter 2, chapter 3, chapter 6, chapter 7
4. 4Musunuru, K. et al., Patient-Specific In Vivo Gene Editing to Treat a Rare Genetic Disease, New England Journal of Medicine 2025 (abstract read through the Europe PMC record; one infant, two infusions at about 7 and 8 months of age). Massachusetts Medical Society, Waltham. Observation year 2025. Accessed 2026-11-03. Cited in the summary, chapter 1, chapter 2, chapter 5, chapter 6
5. 5Clinical Trials Arena (ed.), FDA unveils new pathway to usher bespoke therapies to market (trade press, 13 November 2025; describes the plausible mechanism pathway announced in a journal article by the FDA Commissioner and the CBER Director; secondary report, weak evidence). Clinical Trials Arena, London. Observation year 2025. Accessed 2026-11-03. Cited in chapter 1, chapter 2, chapter 4, chapter 5, chapter 6, chapter 8
6. 6Vertex Pharmaceuticals (ed.), Vertex Reports First Quarter 2026 Financial Results (company press release read through a wire page; Casgevy revenue USD 42.9 million against USD 14.2 million; pediatric submission completed; company statement, weak evidence). Vertex, Boston. Observation year 2026. Accessed 2026-11-03. Cited in the summary, chapter 1, chapter 2, chapter 3, chapter 6, chapter 8
7. 7Chetlapalli, K. et al., Haploidentical transplant, gene therapy, and standard care in sickle cell disease: a cost-effectiveness analysis, Blood 2026 (abstract read through the Europe PMC record; gene therapy access limited by cost and manufacturing capacity). American Society of Hematology, Washington. Observation year 2026. Accessed 2026-11-03. Cited in chapter 1, chapter 2, chapter 4, chapter 6, chapter 8
8. 8Montano-Campos, J.F. et al., Cost-effectiveness of gene therapy for sickle cell disease in Uganda: tailoring high-income evidence to Uganda context, Gene Therapy 2026 (abstract read through the Europe PMC record). Springer Nature, London. Observation year 2026. Accessed 2026-11-03. Cited in chapter 3, chapter 4, chapter 8
9. 9BioSpace (ed.), Life-threatening liver toxicity triggers FDA freeze on two Intellia gene therapy studies (trade press, 30 October 2025; relays company disclosures; secondary report, weak evidence). BioSpace, Boston. Observation year 2025. Accessed 2026-11-03. Cited in the summary, chapter 1, chapter 2, chapter 4, chapter 5, chapter 6, chapter 7
10. 10Lek, A. et al., Death after High-Dose rAAV9 Gene Therapy in a Patient with Duchenne Muscular Dystrophy, New England Journal of Medicine 2023 (abstract read through the Europe PMC record). Massachusetts Medical Society, Waltham. Observation year 2023. Accessed 2026-11-03. Cited in the summary, chapter 1, chapter 4, chapter 6
11. 11Nurk, S. et al., The complete sequence of a human genome, Science 2022 (abstract read through the Europe PMC record; 3.055 billion base pairs; nearly 200 million base pairs of new sequence). American Association for the Advancement of Science, Washington. Observation year 2022. Accessed 2026-11-03. Cited in the summary, chapter 1, chapter 2, chapter 3, chapter 4, chapter 6, chapter 8
12. 12Liao, W.-W. et al. (Human Pangenome Reference Consortium), A draft human pangenome reference, Nature 2023 (abstract read through the Europe PMC record; 47 phased diploid assemblies; 119 million base pairs added). Springer Nature, London. Observation year 2023. Accessed 2026-11-03. Cited in chapter 1, chapter 2, chapter 3, chapter 4, chapter 6, chapter 8
13. 13National Human Genome Research Institute (ed.), The Cost of Sequencing a Human Genome (fact sheet page; method notes read; the cost values sit in graphs and a linked table that were not read; page updated 16 May 2023). NHGRI, Bethesda. Observation year 2023. Accessed 2026-11-03.
14. 14Illumina (ed.), NovaSeq X Series product page (vendor claims: 16 to 21 Tb per run for NovaSeq X Plus, more than 128 genomes per run, run time about 14 to 48 hours; vendor evidence, weak). Illumina, San Diego. Observation year 2026. Accessed 2026-11-03. Cited in the summary, chapter 1, chapter 2, chapter 3, chapter 6, chapter 7, chapter 8
15. 15Ultima Genomics (ed.), germline genetics product page (vendor claim of a USD 60 genome at list price over 4 wafers on the UG200 series; the browser title reads USD 80; vendor evidence, weak). Ultima Genomics, Newark. Observation year 2026. Accessed 2026-11-03. Cited in the summary, chapter 1, chapter 2, chapter 4, chapter 6, chapter 7, chapter 8
16. 16UK Biobank Whole-Genome Sequencing Consortium, Whole-genome sequencing of 490,640 UK Biobank participants, Nature 2025 (abstract read through the Europe PMC record). Springer Nature, London. Observation year 2025. Accessed 2026-11-03. Cited in the summary, chapter 1, chapter 2, chapter 3, chapter 4, chapter 6, chapter 8
17. 17All of Us Research Program Genomics Investigators, Genomic data in the All of Us Research Program, Nature 2024 (abstract read through the Europe PMC record; 245,388 genomes; 77% from communities under-represented in research). Springer Nature, London. Observation year 2024. Accessed 2026-11-03. Cited in the summary, chapter 1, chapter 2, chapter 4, chapter 6, chapter 8
18. 18Fatumo, S. et al., A roadmap to increase diversity in genomic studies, Nature Medicine 2022 (abstract read through the Europe PMC record). Springer Nature, London. Observation year 2022. Accessed 2026-11-03. Cited in chapter 1, chapter 2, chapter 6
19. 19Sirugo, G., Williams, S.M. and Tishkoff, S.A., The Missing Diversity in Human Genetic Studies, Cell 2019 (abstract read through the Europe PMC record). Cell Press, Cambridge. Observation year 2019. Accessed 2026-11-03. Cited in chapter 1, chapter 2, chapter 6
20. 20Stephens, Z.D. et al., Big Data: Astronomical or Genomical?, PLOS Biology 2015 (abstract read through the Europe PMC record). Public Library of Science, San Francisco. Observation year 2015. Accessed 2026-11-03. Cited in chapter 6, chapter 8
21. 21Grealey, J. et al., The Carbon Footprint of Bioinformatics, Molecular Biology and Evolution 2022 (abstract read through the Europe PMC record; a software upgrade cut one tool footprint by 73%). Oxford University Press, Oxford. Observation year 2022. Accessed 2026-11-03. Cited in the summary, chapter 1, chapter 2, chapter 3, chapter 6, chapter 8
22. 22Lannelongue, L., Grealey, J. and Inouye, M., Green Algorithms: Quantifying the Carbon Footprint of Computation, Advanced Science 2021 (abstract read through the Europe PMC record). Wiley, Weinheim. Observation year 2021. Accessed 2026-11-03. Cited in chapter 1, chapter 2, chapter 6, chapter 8
23. 23Brixi, G. et al., Genome modelling and design across all domains of life with Evo 2, bioRxiv preprint 2025 (abstract read through the Europe PMC record; trained on 9.3 trillion base pairs; not peer reviewed at the time of reading). Cold Spring Harbor Laboratory, New York. Observation year 2025. Accessed 2026-11-03. Cited in chapter 6, chapter 8
24. 24Jinek, M. et al., A programmable dual-RNA-guided DNA endonuclease in adaptive bacterial immunity, Science 2012 (abstract read through the Europe PMC record). American Association for the Advancement of Science, Washington. Observation year 2012. Accessed 2026-11-03. Cited in chapter 4, chapter 6
25. 25Komor, A.C. et al., Programmable editing of a target base in genomic DNA without double-stranded DNA cleavage, Nature 2016 (abstract read through the Europe PMC record). Springer Nature, London. Observation year 2016. Accessed 2026-11-03. Cited in chapter 6
26. 26Anzalone, A.V. et al., Search-and-replace genome editing without double-strand breaks or donor DNA, Nature 2019 (abstract read through the Europe PMC record). Springer Nature, London. Observation year 2019. Accessed 2026-11-03. Cited in chapter 6
27. 27World Health Organization (ed.), Human genome editing: a framework for governance (technical document, 12 July 2021; companion recommendations published separately and not read). WHO, Geneva. Observation year 2021. Accessed 2026-11-03. Cited in the summary, chapter 2, chapter 3, chapter 4, chapter 6, chapter 8
28. 28Royal Society (ed.), Statement from the Organising Committee of the Third International Summit on Human Genome Editing (8 March 2023; convened by the Royal Society, the Academy of Medical Sciences, the US National Academies and The World Academy of Sciences). Royal Society, London. Observation year 2023. Accessed 2026-11-03. Cited in the summary, chapter 1, chapter 2, chapter 4, chapter 6, chapter 8
29. 29UK Parliament (ed.), Genetic Technology (Precision Breeding) Act 2023, 2023 c. 6 (contents page read; section texts not read). UK Parliament, London. Observation year 2023. Accessed 2026-11-03. Cited in chapter 3, chapter 4, chapter 6, chapter 8
30. 30Latham and Watkins (ed.), BIOSECURE Act becomes law, limiting grants with biotechnology companies of concern (law-firm summary; enacted 18 December 2025 in the FY2026 NDAA; OMB list due by 18 December 2026; secondary source of a statute). Latham and Watkins, Los Angeles. Observation year 2025. Accessed 2026-11-03. Cited in the summary, chapter 1, chapter 2, chapter 4, chapter 6, chapter 8
31. 31MedTech Dive (ed.), China to lift Illumina export ban (trade press, November 2025; listing in February 2025, import ban in March 2025, lift on 10 November 2025, instrument sales in China down 54% in the third quarter; secondary report, weak evidence). Industry Dive, Washington. Observation year 2025. Accessed 2026-11-03. Cited in the summary, chapter 1, chapter 2, chapter 3, chapter 4, chapter 8
32. 32MedTech Dive (ed.), Anne Wojcicki bid to buy 23andMe in bankruptcy (trade press, 17 June 2025; USD 305 million bid against a USD 256 million bid; state objections; secondary report, weak evidence). Industry Dive, Washington. Observation year 2025. Accessed 2026-11-03. Cited in chapter 3, chapter 4, chapter 8
33. 33US Bureau of Labor Statistics (ed.), Occupational Outlook Handbook: Genetic Counselors (about 4,200 jobs in 2025; median pay USD 100,040 in May 2025; 10% growth projected 2025 to 2035). BLS, Washington. Observation year 2025. Accessed 2026-11-03. Cited in chapter 4, chapter 6, chapter 8
34. 34Genomics England (ed.), Generation Study: newborn genome sequencing (initiative page; 100,000 babies; more than 200 conditions; recruitment progress not stated). Genomics England, London. Observation year 2026. Accessed 2026-11-03. Cited in chapter 4, chapter 6, chapter 8
35. 35UNVERIFIED, not opened: Vertex Pharmaceuticals (ed.), full-year 2025 results (Casgevy revenue USD 115.8 million in 2025 and USD 10 million in 2024), taken from search-result summaries. Vertex, Boston. Observation year 2025. Accessed 2026-11-03.
36. 36UNVERIFIED, not opened: European Parliament and Council, Regulation (EU) 2026/1388 on plants obtained by certain new genomic techniques (adopted 17 June 2026, published 26 June 2026, applies from 17 July 2028), taken from search-result summaries that differ on some dates. Official Journal of the European Union, Luxembourg. Observation year 2026. Accessed 2026-11-03. Cited in chapter 3, chapter 4, chapter 6, chapter 8
37. 37UNVERIFIED, not opened: US Food and Drug Administration (ed.), draft guidance on the plausible mechanism framework for individualised therapies, February 2026, taken from search-result summaries. FDA, Silver Spring. Observation year 2026. Accessed 2026-11-03. Cited in chapter 4, chapter 6
38. 38UNVERIFIED, not opened: NPR (ed.), Judge approves sale of 23andMe to a nonprofit led by its founder (30 June 2025), taken from a search-result summary; the page returned a service error. NPR, Washington. Observation year 2025. Accessed 2026-11-03. Cited in chapter 3, chapter 4, chapter 8
39. 39UNVERIFIED, not opened: Intellia Therapeutics and trade press on the lifting of the 2025 clinical holds on the MAGNITUDE trials, taken from search-result summaries that differ on dates. Observation year 2026. Accessed 2026-11-03. Cited in chapter 2
40. 40UNVERIFIED, not opened: Ultima Genomics (ed.), UG 100 Solaris launch announcement of 24 February 2025 (USD 80 genome at list price), taken from search-result summaries; vendor evidence, weak. Ultima Genomics, Newark. Observation year 2025. Accessed 2026-11-03. Cited in chapter 2
41. 41UNVERIFIED, not opened: Council of Europe (ed.), Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine (Oviedo Convention), 1997, cited from memory; the page returned an access error. Council of Europe, Strasbourg. Observation year 1997. Accessed 2026-11-03. Cited in chapter 4, chapter 6
42. 42UNVERIFIED, not opened: Lander, E.S. et al., Adopt a moratorium on heritable genome editing, Nature 567, 165 to 168, 2019, cited from memory. Observation year 2019. Accessed 2026-11-03. Cited in chapter 4, chapter 6
43. 43UNVERIFIED, not opened: International Human Genome Sequencing Consortium, Initial sequencing and analysis of the human genome, Nature 409, 860 to 921, 2001, cited from memory. Observation year 2001. Accessed 2026-11-03. Cited in chapter 6
44. 44UNVERIFIED, not opened: Genetic Information Nondiscrimination Act of 2008, Public Law 110-233, United States Congress, cited from memory. Observation year 2008. Accessed 2026-11-03. Cited in chapter 4, chapter 6

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