Labcorp Launches FDA-Approved PTEN Companion Diagnostic for Prostate Cancer

BURLINGTON, N.C., Aug. 4, 2026 /PRNewswire/ -- Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, announced the nationwide availability of Roche's VENTANA® PTEN (SP218) RxDx Assay, the first immunohistochemistry (IHC) companion diagnostic test approved by the U.S. Food and Drug Administration (FDA) to determine PTEN protein loss, also known as PTEN deficiency, in tumors of patients with prostate adenocarcinoma. The assay helps identify patients who may be eligible for treatment with AstraZeneca's TRUQAP® (capivasertib) in combination with abiraterone acetate and prednisone.

Addressing an Unmet Need in Prostate Cancer Care
Excluding skin cancer, prostate cancer is the most common cancer among men in the United States, with more than 330,000 new cases expected each year. PTEN is a tumor suppressor protein that plays a critical role in regulating cell growth. Loss of PTEN protein expression has been associated with more aggressive disease progression and reduced benefit from current standard-of-care therapies in prostate cancer. Until recently, there were no approved treatment options specifically targeting this biology.

The VENTANA PTEN (SP218) RxDx Assay is a companion diagnostic designed to detect PTEN protein loss in prostate cancer tissue specimens, providing clinicians with important biomarker information to help guide treatment decisions and support personalized patient care.

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