FDA-Approved Companion Diagnostic Detects PTEN Loss in Prostate Cancer

Prostate cancer is the most common cancer among U.S. men, with more than 300,000 new cases and over 36,000 deaths each year. As targeted therapies emerge for biomarker-defined subgroups, laboratories need validated methods to triage patients by tumor characteristics and support timely treatment selection. A newly launched FDA-approved immunohistochemistry companion diagnostic now detects a key tumor biomarker in prostate adenocarcinoma.

NeoGenomics (Fort Myers, FL, USA) has launched 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 assay identifies PTEN protein loss in patients who may be eligible for TRUQAP (capivasertib). PTEN IHC CDx is available as a standalone order or within NEO PanTracer Pro for prostate cancer, a coordinated workup that integrates comprehensive genomic profiling (CGP) with cancer-type-directed IHC in a single order.

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The companion diagnostic detects PTEN protein loss in prostate adenocarcinoma tissue using the VENTANA PTEN (SP218) RxDx Assay. Testing is performed by NeoGenomics pathologists across the company’s national oncology laboratory network. When ordered on its own, results are reported in as few as one to two days; the test is also included within the NEO PanTracer Pro workflow.

By adding PTEN IHC CDx, NeoGenomics expands its offering in urologic oncology and addresses settings where community practices manage most patients with advanced disease. The test can be ordered as a single national laboratory service or embedded within a broader molecular workup, aligning with real-world diagnostic workflows and turnaround time expectations.

“Clinicians treating this aggressive form of prostate cancer have long needed both a targeted therapy and a validated way to identify eligible patients. 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,” said Nathan Montgomery, Vice President, Medical Services, NeoGenomics.

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