The immunohistochemistry companion diagnostic detects PTEN protein loss to help identify prostate cancer patients who may benefit from capivasertib.
NeoGenomics launched PTEN IHC CDx, the first immunohistochemistry companion diagnostic test approved by the Food and Drug Administration (FDA) for patients with prostate adenocarcinoma, according to a company press release.
The test identifies PTEN protein loss, also known as PTEN deficiency, in patients who may be eligible for capivasertib, a recently approved targeted therapy from AstraZeneca. The test is performed by NeoGenomics pathologists across its national oncology laboratory network and is available as a standalone order or as part of the NEO PanTracer Pro for prostate cancer. The company describes the latter as a comprehensive molecular workup that combines genomic and protein testing in a single order.
“Clinicians treating this aggressive form of prostate cancer have long needed both a targeted therapy and a validated way to identify eligible patients,” says Nathan Montgomery, vice president of medical services at NeoGenomics, in a release. “With PTEN IHC CDx now integrated into NEO PanTracer Pro, community oncology practices have an FDA-approved companion diagnostic available through a single national laboratory partner, reflecting our commitment to providing the tools clinicians need for timely treatment decisions when new therapies become available.”
Prostate cancer is the most common cancer in men in the US, with more than 300,000 new cases and over 36,000 deaths annually, according to NeoGenomics. Of the approximately 35,000 patients diagnosed each year with certain types of metastatic prostate cancer, about one in four have tumors with PTEN deficiency. This protein loss is detectable through a tissue-based test at the time of diagnosis.
The companion diagnostic assay detects protein loss in prostate adenocarcinoma tissue using the VENTANA PTEN (SP218) RxDx Assay. Results for the standalone order are typically delivered in one to two days, and the test has been approved in New York State, according to the company.
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