Labcorp announced that the US Food and Drug Administration has approved its PGDx elio tissue complete CDx as a companion diagnostic for advanced melanoma patients. The test identifies patients with certain BRAF variants who may benefit from FDA-approved BRAF inhibitors and BRAF/MEK inhibitor combination therapies. Melanoma is the deadliest form of skin cancer, with a five-year survival rate of just 16% for stage IV patients. Targeted therapies offer an important treatment option for patients whose tumours have BRAF alterations. The companion diagnostic is approved for use by qualified healthcare professionals across hospitals and clinical laboratories. As a kit-based solution, it can be implemented directly within hospitals and health systems, expanding testing access whilst enabling organisations to retain samples for future clinical research.

Labcorp expands access to FDA-approved PTEN diagnostic test for prostate cancer. 6 Aug 2026 Labcorp (NC, USA) has announced US-wide availability of the VENTANA PTEN (SP218) RxDx Assay, Roche's immunohistochemistry (IHC) companion diagnostic test for prostate cancer, marking a significant step forward in precision oncology. With the American Cancer Society (GA, USA) estimating >330,000 new cases of prostate cancer in 2026 in the United States, there is an urgent need for advanced diagnostic tools in this area. In recent years, focus has shifted to the tumor suppressor protein PTEN (phosphatase and tensin homolog on chromosome 10), which has been shown to play a critical role in regulating cell growth. Loss of PTEN protein expression has been linked with more aggressive disease progression and reduced benefit from current standard-of-care therapies in prostate cancer patients. You may also be interested in: The VENTANA PTEN (SP218) RxDx Assay is the first IHC companion diagnostic test approved by the US FDA for determining PTEN protein loss in the tumors of patients with prostate adenocarcinoma. The assay equips clinicians with critical biomarker information to help steer 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," commented Shakti Ramkissoon, Vice President and 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." The assay facilitates the identification of patients who could be eligible for treatment with TRUQAP(R)(capivasertib), developed by AstraZeneca (Cambridge, UK). Now available through Labcorp's network of US-based laboratories, the assay complements the company's comprehensive portfolio of testing services supporting precision oncology care.

Labcorp has launched nationwide availability of Roche's VENTANA PTEN (SP218) RxDx Assay, the first FDA-approved immunohistochemistry companion diagnostic test for prostate cancer. The assay detects PTEN protein loss in prostate adenocarcinoma tumors, helping identify patients eligible for treatment with AstraZeneca's TRUQAP (capivasertib) in combination with abiraterone acetate and prednisone. PTEN is a tumor suppressor protein that regulates cell growth. Loss of PTEN protein expression has been associated with more aggressive disease progression and reduced benefit from standard therapies. Labcorp participated in Roche's early access programme to support Day 1 laboratory readiness for the assay. The test is now available through Labcorp's national network of laboratories and complements the company's comprehensive portfolio of genomic and molecular testing services supporting precision oncology care.