Validated companion diagnostic offers rapid results and supports eligible patient selection for newly approved targeted therapy

NeoGenomics, Inc. (NASDAQ: NEO), a leading provider of oncology testing services, today announced the commercial launch of c-MET CDx for NSCLC, its c-MET companion diagnostic immunohistochemistry (IHC) assay. The test is now available to oncologists and pathologists nationwide, supporting treatment selection for patients with advanced non-small cell lung cancer (NSCLC) with a 48-hour turnaround time.

The c-MET CDx for NSCLC assay detects c-Met protein overexpression, a biomarker observed in up to 50% of patients with advanced NSCLC.¹ It is designed to help identify patients who may be eligible for newly approved targeted therapies, including EMRELIS™ (telisotuzumab vedotin-tllv), which was recently approved by the U.S. Food and Drug Administration (FDA).*

“Accurate and timely biomarker testing is critical in lung cancer, where targeted therapies can meaningfully change the course of a patient’s treatment,” said Dr. Nathan Montgomery, Vice President of Medical Services at NeoGenomics. “The c-MET CDx for NSCLC assay adds an important tool to our testing portfolio, helping oncologists quickly identify patients who may benefit from MET-directed therapies. It also complements our PanTracer™ suite, enabling comprehensive biomarker profiling for NSCLC.”

Key features of NeoGenomics’ assay include:

• Companion Diagnostic Indication: Developed in accordance with FDA guidance and validated for use with MET-targeted therapies.
• Fast Turnaround: Delivers results within 48 hours to enable timely, informed clinical decisions.
• Validated Performance: Designed for use with tumor tissue samples to detect MET protein overexpression.
• Integrated NSCLC Offering: Complements NeoGenomics’ broader PanTracer™ portfolio, including genomic and immuno-oncology markers.

The c-MET CDx for NSCLC assay is now available as part of NeoGenomics’ comprehensive NSCLC testing portfolio. Its addition supports the growing use of MET-directed therapies and reflects ongoing efforts to align diagnostic services with emerging standards in precision cancer care.

For more information or to order the test, visit www.neogenomics.com/cmetcdx.

*EMRELIS™ (telisotuzumab vedotin-tllv) was approved by the U.S. FDA on May 14, 2025, for adults with previously treated advanced NSCLC with high c-MET protein overexpression.

About NeoGenomics, Inc.

NeoGenomics, Inc. is a premier cancer diagnostics company specializing in cancer genetics testing and information services. We offer one of the most comprehensive oncology-focused testing menus across the cancer continuum, serving oncologists, pathologists, hospital systems, academic centers, and pharmaceutical firms with innovative diagnostic and predictive testing to help them diagnose and treat cancer. Headquartered in Fort Myers, FL, NeoGenomics operates a network of CAP-accredited and CLIA-certified laboratories for full-service sample processing and analysis services throughout the U.S. and a CAP-accredited full-service sample-processing laboratory in Cambridge, United Kingdom.

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References

1. Camidge DR, Barlesi F, Goldman JW, et al. Phase Ib Study of Telisotuzumab Vedotin in Combination With Erlotinib in Patients With c-Met Protein-Expressing Non-Small-Cell Lung Cancer. J Clin Oncol. 2023;41(5):1105-1115. doi:10.1200/JCO.22.00739

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