Draft, not yet released. In stewardship review. Not indexed until the first approved release.

Risks and capability

Four genomics risk objects open the portfolio. Order carries no rank. Each is read across driver, exposure, vulnerability, capacity, cascade and consequence.

7 min read0 figures1 table27 notesNR-XTECH-GENOMICS-GLOBAL-2026-BASELINE

Contents
  1. ·Edition home
  2. ·Executive summary
  3. 1Genomics is data infrastructure and a therapeutic frontier
  4. 2Key findings
  5. 3Systems and sectors at baseline
  6. 4Risks and capability
    1. 4.1 Risk objects
    2. 4.2 Capability ladder
  7. 5Individualised editing outpaces delivery systems
  8. 6Readings from the other desks
  9. 7The 2027 agenda
  10. 8Systems in depth
  11. AMethodology
  12. BData appendix
  13. CReferences and record
  14. ·Complete edition, for print

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.

Table 4.1Capabilities on the ladder of evidence: listed, exists, demonstrated, tested
FunctionRungLevelStrongest public evidence at baseline
Prevention and mitigationEXISTSnewborn and population screening programmes running34
Monitoring and observationLISTEDno common tracker of treatment counts or long-term safety
Early warningLISTEDsafety signals reach the public through company disclosures9
Preparedness and planningEXISTSWHO framework and approval pathways1527
Redundancy and reservesLISTEDinstrument and reagent reserves are not documented
ResponseEXISTSclinical holds and monitoring rules were applied in 20259
Continuity of critical servicesLISTEDcold-chain continuity for cell therapies not documented
RecoveryLISTEDnot applicable at baseline
AdaptationEXISTSnew pathways for individualised therapies are being drafted537
Social protectionLISTEDaccess in low-income settings is limited8
Finance and insuranceLISTEDprice negotiations ongoing; payer data not bound7
Institutional coordinationEXISTSsummits and WHO governance work2728
Technical infrastructureEXISTSreference genomes and biobanks available111617
WorkforceLISTEDgenetic counsellor numbers known; wider workforce not bound33
Research capacityADEQUATEstrong peer-reviewed base2111224
A capability listed in policy is not a tested one; each rung is the strongest public evidence at baseline.

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

Cite this chapter

Valadbaygi, S. (Ed.). (2026). Chapter 4: Risks and capability. In Exponential Technology Report 2026: Genomics and Gene Editing (Baseline Edition 2026, Report No. NR-XTECH-GENOMICS-GLOBAL-2026-BASELINE) [Draft under review]. The Global Centre for Risk and Innovation (GCRI).

Every citation form of the whole report, BibTeX and RIS included, is on the edition home. Cite this report

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