Caris Life Sciences announced that the final results of its Achieve 1 clinical trial for the Caris Detect multi‑cancer early detection test have been released. The study enrolled 3,014 participants, including high‑risk, symptomatic, and imaging‑identified patients, and provides the most comprehensive performance data yet for a whole‑genome sequencing–based assay.
The final data show an overall stage‑I sensitivity of 56.8 % and a stage‑IV sensitivity of 99.1 %. Specificity for asymptomatic patients is 99.1 %, while specificity for benign or high‑risk cases is 95.3 %. Breast cancer sensitivity is 53.0 %, prostate 78.9 %, and lung 86.7 % (stage‑I/II). These metrics confirm that the test can detect early‑stage disease with high accuracy across a broad range of cancers.
"Our hypothesis has been that cancer is a disease driven by molecular aberrations that can manifest itself in many different forms. For example, driver mutations, changes in epigenomics, changes in transcriptomics and changes in aneuploidy. Most other attempts to derive insights into blood‑based early detection modalities have relied upon epigenomics. Caris approached this from a broader biological perspective to encompass as many genomic alterations as can be attained from extreme ultra‑deep Whole Genome Sequencing," said David Spetzler, President of Caris Life Sciences. "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. 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.
"By combining our advanced precision medicine technologies with Everlywell's consumer‑focused platform, we're creating a powerful new pathway for people to detect cancer at its earliest and most treatable stages, before it can spread, ultimately supporting better outcomes for patients."
The finalized results give Caris a stronger evidence base to launch Caris Detect in the first half of 2026. The company’s whole‑genome sequencing approach differentiates it from competitors that rely on methylation‑based methods, such as Grail’s Galleri test. By expanding the test’s analytical pillars and leveraging its extensive clinico‑genomic database, Caris aims to improve detection performance and provide AI‑driven interpretation, positioning the company to capture a growing share of the multi‑cancer early detection market.
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