NeoGenomics, Inc. (NASDAQ: NEO) has launched PTEN IHC CDx, an FDA-approved immunohistochemistry companion diagnostic test for patients with prostate adenocarcinoma, according to a company press release.

The test detects PTEN protein loss in prostate tissue using the VENTANA PTEN (SP218) RxDx Assay. It is authorized to identify patients with metastatic prostate cancer who may be eligible for AstraZeneca's TRUQAP (capivasertib), a targeted therapy approved by the FDA in June 2026.

The test is available as a standalone order, with results delivered in as few as one to two days, or as part of NeoGenomics' NEO PanTracer Pro for prostate cancer, which combines comprehensive genomic profiling with cancer-type-directed IHC testing in a single order. The test has also received approval in New York State.

Prostate cancer accounts for more than 300,000 new diagnoses and over 36,000 deaths annually in the United States. Of the approximately 35,000 patients diagnosed each year with metastatic prostate cancer, roughly one in four — or about 8,750 patients — have PTEN-deficient tumors.

"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," said Nathan Montgomery, Vice President of Medical Services at NeoGenomics.

The test is performed by NeoGenomics pathologists across its national oncology laboratory network.