ClearNote Health advanced commercialization steps for its pancreatic cancer early detection test, Avantect Pancreatic Cancer, presenting updated performance after adding a glycan biomarker CA19-9 to its 5-hydroxymethylcytosine (5hmC) and cfDNA fragment size approach. In a validation cohort of 1,445 high-risk patients, the company reported overall sensitivity of 82.6% and specificity of 97.5%. Stage-specific results were also reported, with early-stage sensitivity at 76.8% in the validation set and commentary that stage I sensitivity varies by cohort but remains within a reported 60% to 70% range. The company said performance was consistent across additional validation cohorts including patients with new-onset type 2 diabetes. For developers of early detection tests, the update highlights how multi-analyte epigenetic and clinical markers are being combined to improve discrimination in high-risk populations.
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