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The validation of Quest's Haystack blood test for leftover cancer, which reports results as a count of tumour DNA molecules per millilitre of plasma.
Haystack MRD tracks patient-specific somatic mutations with background noise suppression. Analytical validation used reference materials and clinical specimens across 23 tumour types, followed by clinical validation in stage II to III colorectal cancer and real-world evaluation across 27 cancer types. The 95 per cent limit of detection was 0.063 mean ctDNA molecules per mL, with an analytical measurement range of 0.25 to 1,000; concordance with expected residual disease status was 99 per cent (95% CI 94.2 to 99.9), and quantitative measurements agreed with an orthogonal method (R2 = 0.9998). In early colorectal cancer, post-treatment status gave 100 per cent sensitivity and specificity for recurrence at three years, and 83.3 per cent sensitivity and 100 per cent specificity at five years.
At these levels the honest unit is a count of molecules, not an allele fraction, which is the counting limit behind attributing residual disease to a clone.
Shares Naming which clone or phenotype is left after treatment, Tumour-informed versus tumour-naive ctDNA assays, Minimal / molecular residual disease (MRD), Circulating tumour DNA (ctDNA).
Shares Naming which clone or phenotype is left after treatment, Tumour-informed versus tumour-naive ctDNA assays, Minimal / molecular residual disease (MRD), Circulating tumour DNA (ctDNA).
Shares Tumour-informed versus tumour-naive ctDNA assays, Minimal / molecular residual disease (MRD), Circulating tumour DNA (ctDNA), MRD / molecular residual disease testing.
Shares Naming which clone or phenotype is left after treatment, Tumour-informed versus tumour-naive ctDNA assays, Minimal / molecular residual disease (MRD), Circulating tumour DNA (ctDNA).
Shares Tumour-informed versus tumour-naive ctDNA assays, Minimal / molecular residual disease (MRD), Circulating tumour DNA (ctDNA), MRD / molecular residual disease testing.
Shares Naming which clone or phenotype is left after treatment, Tumour-informed versus tumour-naive ctDNA assays, Minimal / molecular residual disease (MRD), Circulating tumour DNA (ctDNA).
Shares Tumour-informed versus tumour-naive ctDNA assays, Minimal / molecular residual disease (MRD), Circulating tumour DNA (ctDNA), MRD / molecular residual disease testing.
Shares Haystack MRD, Tumour-informed versus tumour-naive ctDNA assays, Minimal / molecular residual disease (MRD), Circulating tumour DNA (ctDNA).
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