NeoGenomics, Inc. announced the launch of 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 test identifies PTEN protein loss, also known as PTEN deficiency, in patients who may be eligible for AstraZeneca’s recently approved targeted therapy TRUQAP (capivasertib). This diagnostic advancement extends NeoGenomics' reach into urologic oncology, where community practices manage the majority of patients with advanced prostate cancer.

PTEN IHC CDx is available as a standalone order or as part of NEO PanTracer Pro for prostate cancer. NEO PanTracer Pro is a comprehensive molecular workup that combines comprehensive genomic profiling (CGP) and cancer-type-directed IHC testing in a single order. The test is performed by NeoGenomics’ pathologists across its national oncology laboratory network and has been approved in New York State.

Clinical Significance

Prostate cancer is the most common cancer in men in the United States, with more than 300,000 new cases and over 36,000 deaths annually. Of the approximately 35,000 patients diagnosed each year with mAPMN/S prostate cancer (formerly mHSPC), about one in four—or approximately 8,750 patients—have PTEN-deficient tumors. PTEN protein loss is detectable through a tissue-based test at the time of diagnosis.

Test Availability and Specifications

The PTEN IHC CDx assay detects PTEN protein loss in prostate adenocarcinoma tissue using the VENTANA PTEN (SP218) RxDx Assay. It is authorized by the FDA to identify patients with mAPMN/S prostate cancer who may be eligible for TRUQAP.

"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."

NeoGenomics, Inc. is a premier cancer diagnostics company specializing in cancer genetics testing and information services. Headquartered in Fort Myers, FL, the company operates a network of CAP-accredited and CLIA-certified laboratories throughout the US and a CAP-accredited full-service sample-processing laboratory in Cambridge, England.

NeoGenomics will report its second quarter 2026 financial results after the close of U.S. financial markets on Tuesday, July 28, 2026. The company provides oncology diagnostic solutions that enable precision medicine. Management will host a webcast and conference call at 4:30 p.m. ET to discuss the financial results and recent highlights.

Conference Call Details

The live webcast can be accessed through the Investor Relations section of the company website at ir.neogenomics.com. An archived replay will be available shortly after the call concludes.

To participate via telephone, investors must dial at least five minutes prior to the start time. The domestic number is (888) 506-0062, while the international number is (973) 528-0011. The participant access code required to join the call is 968605.

About NeoGenomics

NeoGenomics is a cancer diagnostics company specializing in cancer genetics testing and information services. It offers a comprehensive oncology-focused testing menu across the cancer continuum. The company serves oncologists, pathologists, hospital systems, academic centers, and pharmaceutical firms with diagnostic and predictive testing to guide personalized care decisions.

Headquartered in Fort Myers, FL, NeoGenomics operates a network of CAP-accredited and CLIA-certified laboratories throughout the US. It also maintains a CAP-accredited full-service sample-processing laboratory in Cambridge, England.