Code
APH-CMET-01AX
Test
Active-Compendium
88360
Clinical
Pathology
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.
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.
Flag Active
True
Orderable Test Description
<p>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.<br> <br>
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 HGFR (MET) protein expression 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) protein, also known as hepatocyte growth factor receptor and previously abbreviated as c-MET.</p>
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 HGFR (MET) protein expression 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) protein, also known as hepatocyte growth factor receptor and previously abbreviated as c-MET.</p>
Orderable Turn Around Time
Global: 2 Day, Tech-Only (stain only): 1 Day
Orderable Biomarkers
NY Approved
True
Orderable Biomarkers JSON
{"Immunohistochemistry (IHC)": {"Expression": ["c-MET"]}}
Keywords string
cMET, c-met receptor tyrosine kinase, c-MET expression, c-MET IHC, cMET CDx, CDx c-MET CDx for NSCLC
Title URL
c-met-cdx-for-nsclc
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.