Caris Life Sciences announces finalized Achieve 1 Study results

Caris Life Sciences (CAI) announced the finalized Achieve 1 Study results. These results represent a major milestone in Caris’ goal to detect cancer earlier, through the future launch of Caris Detect, its multi-cancer early detection test, the company said. The Achieve 1 Study systematically assessed Caris Detect’s diagnostic accuracy across a heterogeneous patient cohort, quantifying its efficacy in identifying multiple cancer types at early stages through peripheral blood sampling. A total of 3,014 subjects were enrolled and evaluable based on high-risk screening, symptomatic presentation, or identification of a mass on imaging, representing a population with elevated cancer prevalence relative to baseline. Of note, in the blinded validation set, 36 cancer patients had no staging information, 34 were on treatment or blood was collected after intent-to-treat surgery, and 24 failed to produce results meeting minimum sample quality metrics. Each of these patient groups were excluded from the results. “Finalizing the Achieve 1 results is a pivotal milestone for Caris Detect, because it moves our performance assessment from an interim view to a complete, reported-out data set,” said David Spetzler, MS, PhD, MBA, President of Caris Life Sciences. “This data was generated analyzing only one of nine pillars. With this study, we have validated that our Whole Genome Sequencing approach detects the diverse molecular changes that drive cancer and quantifies performance with greater confidence across stages and patient populations. This data reinforces our view that relying on a narrow slice of biology is not sufficient for early detection. We intend to add additional pillars, including Whole Transcriptome Sequencing, which we believe will strengthen and improve the overall performance of the test.”