NeoGenomics (NASDAQ: NEO) has announced the launch of the PTEN IHC CDx assay, the first immunohistochemistry companion diagnostic for prostate adenocarcinoma patients to receive approval from the U.S. Food and Drug Administration.

This test is designed to identify patients with a loss of the PTEN protein, aiding in the selection of those who may be suitable for treatment with AstraZeneca's targeted therapy TRUQAP (capivasertib), which recently received FDA approval. The PTEN IHC CDx can be ordered as a standalone test or as part of the NEO PanTracer Pro prostate cancer molecular testing panel, which combines comprehensive genomic analysis with cancer-type-specific immunohistochemistry in a single order.

The assay is performed by pathologists within the company's national oncology laboratory network. When ordered alone, results are typically available within one to two days, and its use is approved in the state of New York.

Nathan Montgomery, Vice President of Medical Services at NeoGenomics, stated that clinicians treating aggressive prostate cancer have long needed targeted therapies and the corresponding tools to identify eligible patients. The integration of PTEN IHC CDx into the NEO PanTracer Pro panel provides community oncology clinics with an FDA-approved companion diagnostic option.

Prostate cancer is the most common cancer among men in the United States, with over 300,000 new cases and more than 36,000 deaths annually. Among the approximately 35,000 patients with metastatic castration-resistant prostate cancer (mCRPC) each year, about one-quarter have PTEN-deficient tumors, affecting roughly 8,750 individuals. The loss of the PTEN protein can be identified through tissue testing at the time of diagnosis.

Headquartered in Fort Myers, Florida, NeoGenomics is a cancer diagnostics company specializing in oncology genetic testing and information services, operating a network of laboratories across the United States that are accredited by the College of American Pathologists (CAP) and certified under the Clinical Laboratory Improvement Amendments (CLIA).