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.
Shares Variant allele frequency (VAF), Natera, Guardant Health, Biomarkers are not validated or standardised.
Shares GRAIL, Circulating tumour DNA (ctDNA), Liquid biopsy (ctDNA).
Shares Natera, Guardant Health, Circulating tumour DNA (ctDNA), Liquid biopsy (ctDNA).
Shares Variant allele frequency (VAF), Guardant Health, Biomarkers are not validated or standardised.
Shares Natera, Guardant Health, Circulating tumour DNA (ctDNA), Liquid biopsy (ctDNA).
Shares Guardant Health, Circulating tumour DNA (ctDNA), Liquid biopsy (ctDNA).
Shares Variant allele frequency (VAF), Circulating tumour DNA (ctDNA), Liquid biopsy (ctDNA).
Shares Variant allele frequency (VAF), Circulating tumour DNA (ctDNA), Biomarkers are not validated or standardised, Liquid biopsy (ctDNA).