The Global Centre for Risk and Innovation (GCRI)
Diagnostics detect disease; therapeutics and vaccines prevent or treat it. Biotechnology has transformed both, from molecular tests to biologic medicines and platform vaccines. This topic, studied at Biotechnology and Biosecurity, a platform of The Global Centre for Risk and Innovation (GCRI), examines how health innovations are evaluated, how evidence of performance is generated and judged, and how access and supply shape their value in practice. It is research, not clinical guidance.
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Diagnostics and therapeutics are the tests, medicines and vaccines that detect and treat disease, and the systems that evaluate, approve, manufacture and distribute them. This page covers readiness and access: regulatory evaluation and emergency use listing, prequalification, manufacturing capacity and equitable distribution of medical countermeasures. Approval decisions stay with regulators and WHO.
The working screen behind this subject: its structure, terms and states. Names are placeholders and values illustrative.
Diagnostics and therapeutics · National committee · Review year 3
| Institution A | Active | Q2 | 84 | Current |
| Research campus | Active | Q1 | 61 | Audit due |
| Biomanufacturing site | Forming | none | 67 | Support |
| Diagnostic network | Active | Q3 | 88 | Current |
A diagnostic test's usefulness depends on its sensitivity and specificity and on how common the condition is in the population tested, so the same test can perform differently in different settings. Therapeutics and vaccines are evaluated through staged trials, with regulators weighing evidence of benefit against risk. Emergency procedures can accelerate this process, at the cost of more uncertainty at the time of decision.
Platform technologies, which can be adapted to new targets, have shortened development times for some countermeasures. Yet value in practice depends on manufacturing, distribution, affordability and trust. Surveillance after approval detects rare adverse effects that trials are too small to find. Population health questions are studied at Health Nexus.
Systematic reviews and meta-analyses pool results across studies, with attention to bias.
Methods from probability and statistics assess test accuracy, trial design and uncertainty.
Frameworks compare benefits, risks and costs, drawing on epidemiology and public health science.
Trials may not represent all populations, published evidence can be biased toward positive results, and performance in practice often differs from performance in trials.
Each term as this page uses it. Where a standard-setting body defines the term, the wording follows that body.
| Term | Definition |
|---|---|
| Medical countermeasures | Vaccines, therapeutics, diagnostics and protective equipment used to prevent or respond to health threats. |
| Emergency Use Listing | WHO's procedure for assessing unlicensed products for use during a public health emergency. |
| WHO prequalification | WHO's assessment of medicines, vaccines and diagnostics against quality, safety and efficacy standards, used by procurers. |
| Advance purchase agreement | A contract to buy a product before it is approved, reserving supply in exchange for funding or risk-sharing. |
This evidence informs regulatory decisions, procurement and stockpiling, health technology assessment and preparedness planning. Regulators, health agencies and clinicians decide; GCRI is not a health-service provider or clinical authority. The insurance-sector reading of health innovation and pandemic risk is built by Insurance Nexus at The Global Risks Alliance (GRA). Related topics are biomanufacturing, biological threats and One Health impacts; methods sit on epidemiology and public health science and probability and statistics.
Published analysis on this topic is designed to carry a named subject reviewer, its references and the views of independent specialists, including biosafety professionals and those who disagree.
The current service level is R0: information and enquiries. An enquiry receives a reference and names the next step; applications, payments, compute allocations and registrations open only when their team, terms and review capacity exist.