OnCo
ideasIdea

An annual blinded shoot-out for liquid biopsy tests

Once a year, send the same blinded blood samples to every company selling a tumour-DNA test and publish how each performed.

The FDA-led SEQC2 project compared ctDNA assays on reference samples once. Making this an annual, blinded round with contrived and clinical samples spanning variant types and allele fractions, published with assay names, would create continuous pressure on performance and detect degradation when assays change versions. Participation would be a condition of regulatory clearance or reimbursement.

Hypothesis
Annual publication will drive the median sensitivity at 0.5% allele fraction across participating assays up by at least ten percentage points over three rounds, and will identify at least one assay whose performance changed with a version update.
Rationale
Continuous, public benchmarking works in machine learning and in proficiency testing; a single published comparison quickly goes out of date.
What would test it
Run the first round with ten assays; publish; repeat annually and track performance trajectories.
Maturity
early clinical
Who has to act
regulator
Cost to try
Small (under $1M)
Years to first evidence
1
Bottlenecks it attacks

Connected

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Pages like this

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technologies

1
Liquid biopsy (ctDNA)

companies

3
GRAILGuardant HealthNatera

terms

2
Circulating tumour DNA (ctDNA)Variant allele frequency (VAF)

ideas

2
Certified reference samples to benchmark every tumour-DNA blood testPublic gold-standard datasets for validating every cancer biomarker test

bottlenecks

1
Biomarkers are not validated or standardised