NeoGenomics, Inc. has finalized a civil settlement with the Department of Justice (DOJ) regarding an investigation into consulting services provided to healthcare providers. The settlement resolves issues related to the company's Laboratory Collaboration Initiative program, which involved laboratory testing services. NeoGenomics self-disclosed the matter to the Office of Inspector General of the U.S. Department of Health and Human Services (OIG) in November 2021 and cooperated with the government's investigation.

The company has agreed to pay $9,813,260 plus interest at a rate of 4.250% per annum from January 16, 2026, to the United States. NeoGenomics previously disclosed in its SEC filings that it had accrued a reserve of $11.2 million to cover potential damages and liabilities associated with the investigation. The settlement agreement does not constitute an admission of liability by the company or a concession by the United States that its claims are not well founded.

Tony Zook, Chief Executive Officer, stated that the resolution of this voluntary disclosure allows the company to continue moving forward with its vision for personalized cancer care. The settlement concludes a legacy matter for the oncology diagnostic solutions provider.

Financial Impact of Settlement

The following table outlines the financial details of the settlement agreement:

Background and Cooperation

The investigation focused on consulting services provided by NeoGenomics to certain healthcare providers for laboratory testing services. The DOJ acknowledged the company's cooperation throughout the government's investigation. The Laboratory Collaboration Initiative program was the specific area under scrutiny. NeoGenomics operates a network of CAP-accredited and CLIA-certified laboratories in the US and a CAP-accredited laboratory in the United Kingdom.

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.