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

Test Codes


Specimen Collection Criteria

Collect (preferred specimen): Formalin-fixed, paraffin-embedded block with corresponding H&E slide. Tissue should be well fixed and well processed. 

Also acceptable: One H&E slide plus 4 unstained sections cut at 4 µm thickness and placed on charged slides. Oven dry at 60°C for 1 hour. Unbaked or air-dried slides are acceptable. Tissue adherence cannot be guaranteed for sections placed on plain glass slides. Send all slides within 6 weeks of cutting. 

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/Draw 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.

Inpatient Specimen Preparation

Specimens may be delivered to the front office of the Department of Anatomic Pathology, Beaumont Hospital, Royal Oak.

In-Lab Processing

Unstained sections of 4-µm thickness are cut from selected tissue blocks. The area of tumor is circled by the pathologist on an H&E stained slide.

Maintain specimens at room temperature (20-26°C or 68-78.8°F) until testing.


Specimen Stability for Testing:

Paraffin-Embedded Tissue Block
Room Temperature (20-26°C or 68-78.8°F): Indefinitely
Refrigerated (2-8°C or 36-46°F): Unacceptable
Frozen (-20°C/-4°F or below): Unacceptable

Specimen Storage in Department Prior to Disposal:

Unstained Slides:
Frozen (-25 to -15°C):  3 months


Royal Oak Anatomic Pathology – Advanced Diagnostics Laboratory.


Once per week. Results available in 10 business days.

Reference Range

Negative for ALK Gene Rearrangement. 

Positive for ALK Gene Rearrangement. 

Test Methodology

Fluorescent In Situ Hybridization (FISH) with the Vysis ALK probe (Abbott Laboratories, Chicago, IL).


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 Codes

88366x2, 88374.


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.