Prostate cancer diagnosis in the United States exceeds 300,000 new cases annually, yet therapeutic selection has traditionally relied on clinical observation rather than molecular profiling. The inclusion of PTEN testing addresses a critical gap: approximately one in four patients with this form of prostate cancer harbor PTEN-deficient tumors, which correlate with more aggressive disease progression and poorer clinical outcomes.
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Caris Life Sciences Launches PTEN Testing for Metastatic Prostate Cancer
Caris Life Sciences is integrating PTEN immunohistochemistry testing into its clinical menu, aiming to identify patients with metastatic androgen pathway modulation-sensitive prostate cancer. This diagnostic expansion follows the recent FDA approval of capivasertib, offering a biomarker-driven path for individuals whose tumors exhibit specific protein loss.

By moving this testing in-house at its CAP-accredited and CLIA-certified laboratories, the company seeks to accelerate the delivery of results to oncologists. George W. Sledge, Jr., MD, Chief Medical Officer at Caris, noted that identifying these molecular alterations allows for a shift toward precision oncology, enabling clinicians to match patients with targeted therapies at earlier stages of the disease. This assay functions alongside the company's broader multi-platform molecular profiling, including next-generation sequencing, to provide a more granular view of individual tumor biology.
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