NeoGenomics announces FDA-approved PTEN IHC CDx for prostate cancer
The new PTEN IHC CDx extends NeoGenomics' capabilities into urologic oncology, enabling community practices to detect PTEN deficiency and tailor treatments for advanced prostate cancer patients effectively.
NeoGenomics, Inc. has unveiled PTEN IHC CDx, the first immunohistochemistry (IHC) companion diagnostic test approved by the U.S. Food and Drug Administration (FDA) for patients with prostate adenocarcinoma. The test identifies PTEN protein loss, also known as PTEN deficiency, in patients who may be eligible for AstraZeneca’s recently approved targeted therapy TRUQAP (capivasertib).
PTEN IHC CDx extends the company's reach into urologic oncology, where community practices manage the majority of patients with advanced prostate cancer. Performed by NeoGenomics’ pathologists across its national oncology laboratory network, the test is available as a standalone order or as part of NEO PanTracer Pro for prostate cancer, a comprehensive molecular workup that combines CGP and cancer-type-directed IHC testing in a single order built to evolve with new treatment options.