Caris Life Sciences (NASDAQ: CAI) launched Caris MI Clarity, a test that predicts both early and late distant recurrence risk in breast cancer patients at the time of diagnosis. The test targets postmenopausal patients with HR-positive/HER2-negative, node-negative early-stage breast cancer.

The test analyzes digitized pathology slides and clinical data using artificial intelligence to assess recurrence risk over two time periods: early (0-5 years) and late (5-15 years) after diagnosis. Results are provided within three business days of receiving tissue samples, according to the company.

Caris developed the test using its dataset containing tens of thousands of breast cancer samples. The model was validated through a research partnership with ECOG-ACRIN Cancer Research Group, utilizing samples from clinical trials including TAILORx and NSABP B-42.

The test uses standard pathology specimens collected during routine care and does not require genomic sequencing or additional tissue samples. It provides risk stratification into Low- or High-risk categories for both early and late distant recurrence periods.

"Breast cancer clinicians have long been forced to make some of the most consequential treatment decisions with an incomplete picture of how recurrence risk changes over time," said George W. Sledge Jr., MD, Chief Medical Officer at Caris.

Current risk assessment tools typically focus on one phase of distant recurrence risk, requiring clinicians to evaluate early and late risks separately using different tools and datasets. The company states this fragmented approach adds complexity to treatment planning.

The test addresses distant recurrence, which Caris identifies as the primary driver of breast cancer mortality and a key factor in treatment decisions. In HR-positive disease, recurrence risk can persist for many years, with different biological factors driving early versus late recurrence.