The gatekeeper
The gatekeeper: the 'essential' test, the pair rule, and FDA's group-labeling option.
Free field guide · PDF
IVD Companion Diagnostics2026 Field Guide
The gatekeeper test, codevelopment, and the transatlantic gap — with the CDx strategy you need.
- Essential
- Gatekeeper
- US/EU
- PMA/Class C
- Labeling
- Group
Sourced from verified 2026 publications.
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What's inside
Five pages, zero fluff
Every figure in this guide traces to a named source — verified 2026 publications.
The transatlantic gap
The transatlantic gap: PMA vs IVDR Class C, and the EMA scientific-opinion loop.
The practice
The practice: final-assay discipline, analytical validation, and the oncology pilot path.
Sources & scope
- d33gy59ovltp76.cloudfront.net, FDA Renamed and Updated Its Companion Diagnostics.
- qservegroup.com, Companion Diagnostic Clinical Trials: US and EU regulatory challenges and opportunities.
- lexology.com, FDA pilots oncology companion diagnostic test/device program as LDT rulemaking nears.
This guide is market-access intelligence, not regulatory or legal advice. CDx rules, pilot programs, and agency practice change — professional review is required before business use.
Market Access Strategy Session
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A Market Access Strategy Session maps your CDx route — codevelopment strategy, US/EU sequencing, and analytical validation planning.
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