Labcorp (NYSE: LH) announced the nationwide availability of the VENTANA® PTEN (SP218) RxDx Assay, an immunohistochemistry (IHC) companion diagnostic test developed by Roche to detect PTEN protein loss in prostate adenocarcinoma tumors.

The U.S. Food and Drug Administration approved the assay as a companion diagnostic to identify patients who may be eligible for treatment with AstraZeneca's TRUQAP® (capivasertib) in combination with abiraterone acetate and prednisone. According to the press release, it is the first FDA-approved IHC assay to determine PTEN protein loss in prostate cancer tissue specimens.

Prostate cancer is the most common cancer among men in the United States, excluding skin cancer, with more than 330,000 new cases expected annually. Loss of PTEN protein expression has been associated with more aggressive disease progression and reduced benefit from standard-of-care therapies.

Labcorp said it participated in Roche's early access program to prepare for Day 1 availability of the assay. The test is now accessible through Labcorp's national laboratory network.

"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 and medical lead for oncology at Labcorp.

The assay can be ordered alongside Labcorp's broader oncology testing portfolio, which includes genomic and molecular diagnostic services.