Publish each laboratory's biomarker proficiency results
Labs already get tested on whether they score biomarkers correctly, but the results are private. Publishing them would let hospitals and patients avoid labs that get it wrong.
External quality assessment schemes (NordiQC, UK NEQAS, CAP) show that a meaningful fraction of laboratories fail proficiency runs for HER2, PD-L1, ALK and other predictive markers. Results are confidential. Mandatory participation for any laboratory running companion diagnostics and public reporting of pass rates by laboratory, as is done for hospital infection rates, would create accountability and steer referrals.
- Biomarkers are not validated or standardised · Tests that decide who gets a drug are often not validated prospectively and are measured differently in every lab.
- Fragmented care and guideline gaps · Patients fall between specialists, wait for referrals and often do not get the treatment guidelines say they should.
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not linked directly; found by shared links- TermImmunohistochemistry (IHC)
Shares Record how long tissue waited before fixation in every pathology report, Calibrated reference slides so every lab scores HER2-low the same way, Histopathology & immunohistochemistry, Biomarkers are not validated or standardised.
- IdeaA reliance pathway for companion diagnostics so the test arrives with the drug
Shares Companion diagnostics, Biomarkers are not validated or standardised.
- CompanyAgilent Technologies (Dako)
Shares Companion diagnostics, Histopathology & immunohistochemistry.
- IdeaPathologists order genomic profiling automatically at diagnosis of advanced cancer
Shares Companion diagnostics, Fragmented care and guideline gaps, Biomarkers are not validated or standardised.
- IdeaVersion control and locked reference sets for AI algorithms used as companion diagnostics
Shares Monitor biomarker positivity rates across labs in real time to catch assay drift, Biomarkers are not validated or standardised.
- IdeaAI quantification of HER2-low and HER2-ultralow
Shares Calibrated reference slides so every lab scores HER2-low the same way, Histopathology & immunohistochemistry, Biomarkers are not validated or standardised.
- TermHER2-low and HER2-ultralow
Shares Calibrated reference slides so every lab scores HER2-low the same way, Companion diagnostics, Histopathology & immunohistochemistry, Biomarkers are not validated or standardised.
- IdeaDrug labels must state which biomarker assays were validated and how they compare
Shares Companion diagnostics, Biomarkers are not validated or standardised.