On August 4, 2026 Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, reported 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.
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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.
"Biomarker testing is essential to advancing precision oncology and helping connect patients with the therapies most appropriate for their disease," said Shakti Ramkissoon, M.D., Ph.D., vice president, medical lead for oncology at Labcorp. "The launch of the VENTANA PTEN (SP218) RxDx Assay underscores how Labcorp is expanding access to innovative companion diagnostics and delivering the timely insights physicians need to make personalized treatment decisions."
Advancing Access to FDA-Approved Companion Diagnostics
Labcorp participated in Roche’s early access program to support Day 1 laboratory readiness for the assay, reinforcing the company’s commitment to helping patients gain timely access to newly approved targeted therapies and the companion diagnostics needed to identify eligible patients.
The VENTANA PTEN (SP218) RxDx Assay is now available through Labcorp’s national network of laboratories and complements the company’s comprehensive portfolio of genomic, molecular and companion diagnostic testing services that support precision oncology care. As one of the nation’s largest providers of oncology testing services, Labcorp enables physicians across community and academic settings to access FDA-approved companion diagnostics at scale, helping bring precision medicine to more patients regardless of where they receive care. The assay can also be ordered alongside Labcorp’s broader portfolio of oncology testing services, providing clinicians with comprehensive biomarker insights from a single laboratory partner.
To learn more about the assay, visit View Source
(Press release, LabCorp, AUG 4, 2026, View Source [SID1234669674])