IRVING, Texas, July 14, 2026 /PRNewswire/ -- Caris Life Sciences® (NASDAQ: CAI), a leading patient-centric next-generation AI TechBio company and precision medicine pioneer, today announced it will offer in-house PTEN immunohistochemistry (IHC) testing following the recent FDA approval of a biomarker-guided therapy and companion diagnostic assay. This testing is designed to help identify patients with PTEN-deficient metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer (previously known as metastatic hormone-sensitive prostate cancer) who are eligible for the newly approved biomarker-guided therapy, representing a significant advancement in precision oncology for this disease.
Prostate cancer remains one of the most prevalent malignancies in men, with more than 300,000 new cases diagnosed annually in the United States. The FDA approval of capivasertib, in combination with abiraterone and prednisone, for adults with PTEN-deficient mAPMN/S prostate cancer marks a critical turning point for this disease, enabling a more personalized approach to treatment. Historically, therapy selection in mAPMN/S prostate cancer has relied primarily on clinical characteristics rather than changes in protein expression.
Caris' PTEN IHC testing expands the company's already extensive menu of IHC assays and will enable oncologists to identify patients whose tumors exhibit PTEN protein loss, a key molecular alteration associated with activation of the PI3K/AKT pathway and potential therapeutic relevance. One in four patients with mAPMN/S prostate cancer have PTEN-deficient tumors, which are associated with faster progression and worse outcomes.
"For patients with metastatic hormone-sensitive prostate cancer, treatment decisions have historically been driven largely by clinical factors rather than biomarker-defined molecular alterations," said George W. Sledge, Jr., MD, EVP and Chief Medical Officer at Caris. "The ability to identify PTEN loss through IHC testing brings a new level of precision to treatment selection, helping ensure that the right patients can be matched with biomarker-driven therapies at a critical point in their disease."
Key Highlights of Caris PTEN IHC Testing:
Expanded IHC Capabilities: Caris continues to build one of the most comprehensive IHC testing portfolios in the industry, supporting critical biomarker identification across tumor types.
Support for Biomarker-Driven Therapy Selection: PTEN IHC testing enables identification of PTEN-deficient tumors, supporting treatment decisions in mAPMN/S prostate cancer where FDA-approved biomarker-targeted therapy is now available.