Fort Myers, Fla. — NeoGenomics, Inc. said it has launched PTEN IHC CDx, the first immunohistochemistry companion diagnostic test approved by the U.S. Food and Drug Administration 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 targeted therapy TRUQAP, or capivasertib.
NeoGenomics said PTEN IHC CDx is available as a standalone test or as part of NEO PanTracer Pro for prostate cancer, a molecular workup that combines comprehensive genomic profiling and cancer-type-directed IHC testing in a single order.
The company said the launch expands its reach in urologic oncology, where community practices manage many patients with advanced prostate cancer. The test is performed by NeoGenomics pathologists across its national oncology laboratory network.
“Clinicians treating this aggressive form of prostate cancer have long needed both a targeted therapy and a validated way to identify eligible patients,” said Nathan Montgomery, Vice President, Medical Services, NeoGenomics. “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 United States, with more than 300,000 new cases and more than 36,000 deaths annually, according to the company. Of the roughly 35,000 patients diagnosed each year with mAPMN/S prostate cancer, formerly mHSPC, about one in four, or about 8,750 patients, have PTEN-deficient tumors.
NeoGenomics said PTEN protein loss can be detected through a tissue-based test at the time of diagnosis.
The PTEN IHC CDx assay detects PTEN protein loss in prostate adenocarcinoma tissue using the VENTANA PTEN (SP218) RxDx Assay. The FDA-authorized test is designed to identify patients with mAPMN/S prostate cancer who may be eligible for TRUQAP.
The company said the test can deliver results in as few as one to two days when ordered as a standalone test. It is also available through NEO PanTracer Pro for prostate cancer, which integrates comprehensive genomic profiling with cancer-type-directed IHC and ancillary testing for prostate carcinoma.
NeoGenomics said the test has also been approved in New York State.
