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Test Name:ALK therapeutic by IHC
Test Number:12379
Collect:Formalin-fixed, paraffin embedded (FFPE) tissue block
Container:FFPE tissue block
Processing:Submit processed tissue block or tissue section mounted on a charged, unstained slide.
Transport/Stability:Ambient (preferred)
Alternate Names: ALK (D5F3) CDx Assay
IHC
LAB12376
LAB12379
Performing Lab:AHL - Immunohistochemistry
Days Set Up:Mo - Fr
Expected TAT:1 - 2 days
Ref. Ranges:An interpretive report will be provided
All IHC stains will include a positive control tissue
Collection/
Processing Details:

  • Ventana ALK (clone D5F3)
  • FDA approved test, only for testing in lung adenocarcinomas and non-small cell carcinomas NOS to evaluate for eligibility for ALK targeted therapy
  • Note there are two IHC stains available labeled ALK. ALK1 Lymphoma IMT & ALK therapeutic. The ALK1 Lymphoma IMT should be used for lymphomas and inflammatory myofibroblastic tumor work-ups only. ALK therapeutic is used for stage IV lung adenocarcinomas and non-small cell carcinomas NOS
Specifications:
  • The incidence of ALK gene rearrangements in lung adenocarcinomas is estimated to range from 2-7%.
  • The anaplastic lymphoma kinase (ALK) protein is a member of the insulin receptor superfamily of receptor tyrosine kinases
  • ALK is a type I membrane glycoprotein that is normally expressed only in the nervous system
  • ALK resides at chromosome 2p23 and is constructed mainly of 2 large introns and 26 exons
  • ALK resides at chromosome 2p23 and is constructed mainly of 2 large introns and 26 exons
  • The molecular pathogenesis of ALK begins with chromosomal rearrangements that partner the 3' coding sequences for the intracellular signaling domain with 5' promoter elements and coding sequences of other genes

Staining pattern:
  • Positive staining: Strong granular cytoplasmic staining in one or more tumor cells. The corresponding H&E stained section should be reviewed concurrently with the ALK IHC stained slide
Known staining artifacts:
  1. Nonspecific background staining: Approximately 1-2% of cases will demonstrates weak, diffuse granular cytoplasmic pattern which is above the background staining present on the negative control slide
  2. Granular cytoplasmic staining in normal tissue elements including alveolar macrophages, benign glandular epithelial cells and neuronal tissue elements
  3. Non-specific staining of background mucin
Applications:
  • VENTANA ALK (D5F3) CDx Assay is intended for qualitative detection of the anaplastic lymphoma kinase (ALK) protein in formalin-fixed, paraffin-embedded (FFPE) lung adenocarcinoma and lung non-small cell lung carcinoma (NSCLC)
  • It is indicated as an aid in identifying lung carcinoma patients eligible for treatment with XALKORI┬« (Crizotinib)
References:
  1. Roche Ventana ALK (D5F3) CDx Assay Interpretation Guide for non-small cell lung carcinoma (NSCLC). www.ventana.com.

Method:Immunohistochemical staining
Microscopic examination
CPT Codes:88342 - 1st stain
88341 - each additional stain
Related Article:Temporary methodology change
Date Created:09/13/2017
Revised Date:10/17/2018