The assay identifies PTEN protein loss to help determine patient eligibility for combination therapy with capivasertib.
Labcorp announced the nationwide availability of Roche’s Ventana PTEN (SP218) RxDx Assay, the first immunohistochemistry companion diagnostic test approved by the Food and Drug Administration to determine PTEN protein loss in patients with prostate adenocarcinoma.
The assay identifies patients who may be eligible for treatment with AstraZeneca’s TRUQAP (capivasertib) in combination with abiraterone acetate, and prednisone. PTEN is a tumor suppressor protein that plays a role in regulating cell growth. The loss of PTEN protein expression, also known as PTEN deficiency, is associated with more aggressive disease progression and reduced benefit from standard-of-care therapies.
“Biomarker testing is essential to advancing precision oncology and helping connect patients with the therapies most appropriate for their disease,” says Shakti Ramkissoon, MD, PhD, vice president, medical lead for oncology at Labcorp, in a release. “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.”
Addressing Prostate Cancer Biomarkers
Excluding skin cancer, prostate cancer is the most common cancer among men in the US, with more than 330,000 new cases expected each year. Until recently, there were no approved treatment options specifically targeting PTEN deficiency.
The Ventana PTEN (SP218) RxDx Assay is designed to detect protein loss in prostate cancer tissue specimens. This provides clinicians with biomarker information to help guide treatment decisions and support personalized care.
Labcorp participated in an early access program to support laboratory readiness for the assay. The test is now available through the company’s national network of laboratories.
The assay complements a portfolio of genomic, molecular, and companion diagnostic testing services. It can be ordered alongside other oncology testing services, allowing clinicians to access multiple biomarker insights from a single laboratory partner.
