{"entity":{"id":"idea-tr2-liquid-biopsy-challenge","kind":"idea","name":"An annual blinded shoot-out for liquid biopsy tests","aka":[],"tldr":"Once a year, send the same blinded blood samples to every company selling a tumour-DNA test and publish how each performed.","summary":"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.","asOf":"2026-09-08","links":[{"label":"FDA SEQC2 project (page moved; nearest live section)","url":"https://www.fda.gov/science-research/bioinformatics-tools/"}],"tags":[],"related":["guardant-health","natera","grail","idea-tr2-ctdna-reference-plasma"],"cancers":[],"sections":[],"technologies":["liquid-biopsy"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["ctdna","vaf"],"trials":[],"people":[],"bottlenecks":["b-biomarker-validation"],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"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public benchmarking works in machine learning and in proficiency testing; a single published comparison quickly goes out of date.","test":"Run the first round with ten assays; publish; repeat annually and track performance trajectories.","maturity":"early-clinical","actor":"regulator","cost":"small","horizonYears":1},"route":"/ideas/idea-tr2-liquid-biopsy-challenge/","neighbours":{"company":[{"id":"grail","kind":"company","name":"GRAIL","route":"/companies/grail/"},{"id":"guardant-health","kind":"company","name":"Guardant Health","route":"/companies/guardant-health/"},{"id":"natera","kind":"company","name":"Natera","route":"/companies/natera/"}],"idea":[{"id":"idea-tr2-ctdna-reference-plasma","kind":"idea","name":"Certified reference samples to benchmark every tumour-DNA blood test","route":"/ideas/idea-tr2-ctdna-reference-plasma/"},{"id":"idea-tr2-open-cdx-validation-sets","kind":"idea","name":"Public gold-standard datasets for validating every cancer biomarker test","route":"/ideas/idea-tr2-open-cdx-validation-sets/"}],"technology":[{"id":"liquid-biopsy","kind":"technology","name":"Liquid biopsy (ctDNA)","route":"/technologies/liquid-biopsy/"}],"term":[{"id":"ctdna","kind":"term","name":"Circulating tumour DNA (ctDNA)","route":"/terms/ctdna/"},{"id":"vaf","kind":"term","name":"Variant allele frequency (VAF)","route":"/terms/vaf/"}],"bottleneck":[{"id":"b-biomarker-validation","kind":"bottleneck","name":"Biomarkers are not validated or standardised","route":"/bottlenecks/b-biomarker-validation/"}]}}