Lab Test

Lung Cancer ALK Rearrangements by FISH

Lung Cancer ALK Rearrangements by FISH, Vysis ALK Break Apart FISH Probe (modified FDA Approved assay) , SOFTPATH: MALKG, SOFT MOL: MALKG, SOFT LAB: MALKG

Specimen Collection Criteria

Collect (preferred specimen): Formalin-fixed, paraffin-embedded block with corresponding H&E slide. Tissue should be well fixed and well processed. Tissue size should be 5.0 mm2. Slides or paraffin curls are NOT acceptable.

Specimen must be accompanied by a completed requisition and must contain the patient name, date of birth, collection date, ordering physician, and source of specimen. Provide pathology report with each specimen, including type of fixative and duration of fixation (if known).

Physician Office/Drawsite Specimen Preparation

Maintain paraffin-embedded tissue at room temperature (20-26°C or 68-78.8°F) until transport.

Preparation for Courier Transport

Transport: Paraffin-embedded tissue blocks at room temperature (20-26°C or 68-78.8°F).

Rejection Criteria

  • Tissue that is decalcified using non-approved agents
  • Refrigerated or frozen paraffin embedded tissue
  • Tissue in fixatives other than 10% neutral buffered formalin.
  • Improper labeling or inadequate information.
  • Less than 10 percent tumor cellularity, at discretion of medical director.


Once per week, starting Tuesday.
Results available in 10 business days.

Reference Range

ALK rearrangement not identified.

Test Methodology

Fluorescent In Situ Hybridization (FISH) with the Vysis ALK probe (Abbott Laboratories, Chicago, IL), with analysis by the Ariol Image Analysis system (Leica-Microsystems, San Jose, CA) and Tissue FISH-Pathvysion analysis software.


Test results and the clinical interpretation should be evaluated within the context of the patient's medical history and other diagnostic laboratory test results. If results obtained do not match other clinical or laboratory findings, please contact the laboratory director. An interpretive report will be provided.

Clinical Utility

The Vysis ALK Break Apart FISH Probe Kit is a qualitative test to detect rearrangements involving the ALK gene in pulmonary adenocarcinoma specimens to identify tumors with sensitivity to the tyrosine kinase inhibitor Xalkori® (crizotinib). 

Test Limitations:

  • For In-vitro Diagnostic Use only.
  • This procedure was optimized using FFPE specimens.
  • FISH assay results may not be informative if the specimen quality and/or specimen slide preparation are inadequate, or if the specimen is processed using fixatives or methods other than those listed above.

CPT Code

88366x2, 88374.

Test Codes


Last Updated


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This directory currently reflects information only for specimens collected and/or processed at the
Farmington Hills, Grosse Pointe, Royal Oak, and Troy campuses.