OnCo
ideasIdea

Reference materials and open proficiency testing for residual disease tests

Different companies' leftover-cancer blood tests disagree, and there is no shared yardstick. Public reference samples would let anyone check which test actually works.

Tumour-informed and tumour-naive ctDNA assays report different sensitivities at different variant allele fractions, and cross-assay comparisons are almost entirely vendor-run. A public reference material programme — synthetic and patient-derived contrived plasma at defined fractions, blinded rounds, published per-assay results — would do for MRD what proficiency schemes did for HER2 immunohistochemistry.

Hypothesis
Blinded proficiency testing reveals at least a threefold spread in limit of detection between commercial MRD assays at 0.01% variant allele fraction, and publishing results narrows that spread within two rounds.
Rationale
Every biomarker that decides treatment eventually needs external quality assessment; HER2 and PD-L1 scoring both improved measurably once schemes existed. MRD is about to gate adjuvant therapy decisions, so the cost of unquantified variability is now clinical.
What would test it
A metrology institute or reference laboratory network produces contrived plasma panels and runs one blinded round with five commercial and three academic assays, publishing all results with assay names attached.
Maturity
speculative
Who has to act
regulator
Cost to try
Small (under $1M)
Years to first evidence
3
Bottlenecks it attacks

Connected

11top

Pages like this

not linked directly; found by shared links