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MET (SP44) IHC Non-Squamous NSCLC

CPT

88360

Test Details

Methodology

Immunohistochemistry

Related Documents

Use

The VENTANA MET (SP44) RxDx assay is 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 by light microscopy. The VENTANA MET (SP44) RxDx assay is indicated as an aid in identifying non-squamous NSCLC patients who may be eligible for treatment with EMRELIS™ (telisotuzumab vedotin-tllv).

Special Instructions

Testing will be delayed if the pathology report is not received.

Limitations

Tissue staining is dependent on the handling and processing of the tissue before staining. Improper fixation, freezing, thawing, washing, drying, heating, sectioning or contamination with other tissues or fluids may produce artifacts or false negative results. Inconsistent results may arise from variations in fixation and embedding methods.

The recommended fixative is 10% NBF. Fix samples in formalin for six to 72 hours. Zinc formalin is also acceptable for fixative time of six to 72 hours. Samples fixed in formalin and zinc formalin for fixation times less than six 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. When fixative type and/or fixation duration are unknown or outside of the recommended parameters, and a negative test result is obtained, consider including a statement in the pathology report that retesting with a new sample collected and prepared according to the recommended device specifications may be warranted. 

Patient tissue sections should be refrigerated (5ºC ± 3ºC) and stained within 45 days of sectioning from the tissue block. Storage outside of recommended conditions have demonstrated a loss of specific MET immunoreactivity and can lead to a false negative result. This assay has not been validated for use with cytology smears or decalcified specimens.

 

Specimen Requirements

Specimen

Formalin-fixed, paraffin-embedded (FFPE) tissue block or slides

Volume

One paraffin block or five unstained, positively charged slides less than one month old

Minimum Volume

Three unstained, positively charged slides

Container

Paraffin block; unstained, positive-charged slides

Collection Instructions

Tissue should be fixed in 10% neutral-buffered formalin (NBF) for six to 72 hours. Embed in paraffin. Slides should be no more than one month old.

Storage Instructions

Maintain specimen at room temperature.

Causes for Rejection

Insufficient tumor; tumor other than non-squamous non-small-cell lung cancer; slides sectioned more than one month prior to test request

References

Ventana MET (SP44) RxDx Assay Interpretation Guide for Non-Squamous Non-Small Cell Lung Cancer. May 14, 2025.

Ventana Ventana MET (SP44) RxDx Rabbit Monoclonal Primary Antibody [package insert]. May 14, 2025.

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
412320 MET (SP44) IHC NONSQUAM-NSCLC 412321 Result 77173-3
412320 MET (SP44) IHC NONSQUAM-NSCLC 412322 %Tumor Cells Strong 3+Staining Pending
412320 MET (SP44) IHC NONSQUAM-NSCLC 412323 Comment 77202-0
412320 MET (SP44) IHC NONSQUAM-NSCLC 412324 Interp 77202-0
412320 MET (SP44) IHC NONSQUAM-NSCLC 412325 Review 72486-4
Order Code412320
Order Code NameMET (SP44) IHC NONSQUAM-NSCLC
Order Loinc
Result Code412321
Result Code NameResult
UofM
Result LOINC77173-3
Order Code412320
Order Code NameMET (SP44) IHC NONSQUAM-NSCLC
Order Loinc
Result Code412322
Result Code Name%Tumor Cells Strong 3+Staining
UofM
Result LOINCPending
Order Code412320
Order Code NameMET (SP44) IHC NONSQUAM-NSCLC
Order Loinc
Result Code412323
Result Code NameComment
UofM
Result LOINC77202-0
Order Code412320
Order Code NameMET (SP44) IHC NONSQUAM-NSCLC
Order Loinc
Result Code412324
Result Code NameInterp
UofM
Result LOINC77202-0
Order Code412320
Order Code NameMET (SP44) IHC NONSQUAM-NSCLC
Order Loinc
Result Code412325
Result Code NameReview
UofM
Result LOINC72486-4