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c-MET CDx for NSCLC
- Immunohistochemistry (IHC)
The c-MET CDx for NSCLC test is a companion diagnostic indicated as an aid in identifying non-squamous NSCLC patients who may be eligible for treatment with EMRELIS™ (telisotuzumab vedotin-tllv). Eligibility for EMRELIS treatment includes high c-MET protein overexpression, defined as ≥50% of tumor cells with strong (3+) staining using this assay.
This test implements the VENTANA MET (SP44) RxDx Assay, a qualitative immunohistochemical assay using rabbit monoclonal anti-MET, clone SP44, intended for use in the assessment of MET protein in formalin-fixed paraffin embedded (FFPE) non-squamous non-small cell lung cancer (NSCLC) specimens. This test recognizes MET proto-oncogene, receptor tyrosine kinase (MET), also known as hepatocyte growth receptor and sometimes abbreviated as c-MET.
Specimen Requirements
Preferred: A formalin-fixed, paraffin-embedded (FFPE) tissue block.
Alternative: 1 unbaked, unstained slide for H&E staining (required) and 2 positively charged unstained slides (all cut at 4-5 microns, within 45 days).
A minimum of 100 viable tumor cells is required for evaluation.
Ensure clear labeling of all materials to match the requisition.
The recommended fixative is 10% NBF. Fix samples in formalin for 6-72 hours. Zinc formalin is also acceptable for a fixative time of 6-72 hours. Samples fixed in formalin and zinc formalin for fixation times less than 6 hours have demonstrated a loss of specific MET immunoreactivity and can lead to a false negative result. Fixatives such as AFA, PREFER fixative, Z-fix, Alcohol Formalin and 95% ethanol are not acceptable for use with this assay and have demonstrated a significant loss of specific MET immunoreactivity and can lead to a false negative result.
Storage and Transportation
Use cold pack for transport, making sure cold pack is not in direct contact with specimen. NYS clients please provide date and time of Collection.
CPT Code(s)*
88360
*The CPT codes provided with our test descriptions are based on AMA guidelines and are for informational purposes only. Correct CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed.
Last Updated: July 17, 2025