ClearNote Health advanced its pancreatic cancer early detection platform, presenting updated performance for its Avantect Pancreatic Cancer test at AACR. The update adds an additional biomarker to improve detection capability in a high-risk validation cohort. In a validation cohort of 1,445 high-risk patients (including 259 with cancer), ClearNote reported overall sensitivity of 82.6% with specificity fixed at 97.5%. For early-stage disease, sensitivity was 76.8%, with the company noting stage I sensitivity ranges of roughly 60% to 70% depending on cohort composition. The assay measures 5-hydroxymethylcytosine (5hmC) from cell-free DNA alongside cfDNA fragment size genotyping, then incorporates a glycan biomarker (CA19-9) adjusted through FUT2/3 genotyping to generate a tumor-specific glycan signature. ClearNote reported no major performance differences across additional validation cohorts including those with new-onset type 2 diabetes. The improvements matter for adoption because pancreatic cancer screening is defined by difficult tradeoffs between early-stage sensitivity and high specificity needed to limit false-positive downstream workups.
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