Caris Life Sciences unveiled interim validation results from its Achieve 1 study supporting the planned commercial launch of Caris Detect, a multicancer early detection (MCED) blood assay. In diagnosed patients, sensitivity rose with stage — roughly 57% for stage I, 70% for stage II and 99% for stage IV — while specificity in undiagnosed participants was approximately 95%. Company management emphasized that a blinded validation cohort remains to be reported and that Achieve 2 enrollment is ongoing. Caris plans to process the remaining samples and publish the blinded validation as a pivotal step toward its commercial rollout slated for Q2. The results underscore ctDNA’s potential role as a risk‑stratifying tool for bladder and other cancers, but payers and clinicians will demand robust prospective validation and demonstration of clinical utility before broad adoption.
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