c-MET CDx for NSCLC
Use
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 HGFR (MET) protein overexpression, defined as ≥50% of tumor cells with strong (3+) staining using this assay.
Special Instructions
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.
Limitations
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.
New York Approved
Methodology
Immunoassay (IHC)
Biomarkers
Result Turnaround Time
1-2 days
Related Documents
For more information, please review the documents below
Specimen
Tissue (FFPE)
Volume
Not provided
Minimum Volume
Not provided
Container
A formalin-fixed, paraffin-embedded (FFPE) tissue block. Alternative: 1 unbaked, unstained slide for H&E staining (required) and 2 positively charged unstained slides.
Collection Instructions
A minimum of 100 viable tumor cells is required for evaluation.
Storage Instructions
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.
Causes for Rejection
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.