NeoGenomics, Inc. (NASDAQ: NEO) announced the commercial launch of its c-MET CDx for NSCLC, a companion diagnostic immunohistochemistry (IHC) assay designed to guide treatment decisions for patients with advanced non-small cell lung cancer. The test, now available nationwide to oncologists and pathologists, delivers results within 48 hours to support timely clinical decision-making.
The c-MET CDx assay specifically detects c-Met protein overexpression, a biomarker found in as many as 50% of patients with advanced NSCLC. This diagnostic tool helps identify patients who may benefit from newly approved targeted therapies, including EMRELIS™ (telisotuzumab vedotin-tllv), which received FDA approval on May 14, 2025, for adults with previously treated advanced NSCLC exhibiting high c-MET protein overexpression.
"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."
Clinical Significance and Test Features
Non-small cell lung cancer remains one of the most challenging oncology indications, with patients often requiring precise biomarker identification to match with appropriate targeted therapies. The c-MET pathway has emerged as an important therapeutic target, with overexpression associated with more aggressive disease characteristics.
The newly launched diagnostic offers several key advantages:
- Companion Diagnostic Indication: Developed in accordance with FDA guidance and validated specifically for use with MET-targeted therapies
- Rapid Results: 48-hour turnaround time enables prompt treatment decisions
- Validated Performance: Designed for reliable detection of MET protein overexpression in tumor tissue samples
- Integrated Testing Approach: Fits within NeoGenomics' comprehensive NSCLC testing portfolio, including genomic and immuno-oncology markers
Expanding Precision Medicine in Lung Cancer
The introduction of this companion diagnostic reflects the growing importance of biomarker-driven treatment selection in oncology. For NSCLC patients, the ability to quickly determine c-MET status may significantly impact treatment pathways, potentially offering more personalized therapeutic options.
EMRELIS™, the recently approved antibody-drug conjugate that targets c-MET overexpressing tumors, represents an important addition to the treatment landscape for previously treated advanced NSCLC patients. The availability of a validated companion diagnostic is crucial for appropriate patient selection, potentially improving outcomes while minimizing unnecessary treatment in patients unlikely to respond.
Broader Implications for Cancer Diagnostics
This launch aligns with the broader trend toward comprehensive biomarker profiling in oncology. As part of NeoGenomics' PanTracer™ portfolio, the c-MET CDx assay contributes to a more complete molecular understanding of each patient's cancer.
For healthcare providers, having access to rapid, reliable c-MET testing through a nationally recognized laboratory network helps address the challenges of timely biomarker assessment, which has been identified as a barrier to optimal care in lung cancer management.
The commercial availability of this test underscores NeoGenomics' commitment to advancing precision oncology through diagnostic innovation, supporting the company's position as a leading provider of cancer testing services across the United States.
