ALK Test Comparison

 

There are a number of molecular tests that seek to identify ALK translocations, rearrangements, or mutations. Unlike IHC which is highly subjective and RT/PCR which misses variants, the Vysis ALK test using break-apart FISH technology offers the benefits of:

  • Identifying all ALK gene rearrangements with fusion partners, including but not restricted to EML4, TFG, and KIF5B
  • Reducing false negative results, which provides confidence that patients are correctly identified and aiding pathologists and oncologists in their goal to diagnose and appropriately manage their NSCLC patients

 

ALK Test Comparison


 

 

To Order Lung Order Tests

To View Specimen Collection and Shipping Instructions

 

 

Intended Use

The Vysis ALK Break Apart FISH Probe Kit is a qualitative test to detect rearrangements involving the ALK gene via fluorescence in situ hybridization (FISH) in formalin-fixed paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) tissue specimens to aid in identifying those patients eligible for treatment with XALKORI® (crizotinib).

The test is for prescription use only.

 

Limitations of the Procedure

  • FOR IN VITRO DIAGNOSTIC USE ONLY.
  • Optimal performance of this test requires appropriate specimen handling, preparation, and storage as described in the instructions for use.
  • The Vysis ALK Break Apart FISH Probe Kit has been optimized only for identifying and quantifying rearrangements of the ALK gene from formalin-fixed, paraffin-embedded human NSCLC tissue specimens. The assay should be performed only on 10% neutral buffered formalin FFPE human lung cancer tissue. Other types of specimens or fixatives should not be used.
  • The performance of the Vysis ALK Break Apart FISH Probe Kit was established using the procedures provided in the assay package insert only. Modifications to the procedures may alter the performance of the assay.
  • The clinical interpretation of any test results should be evaluated within the context of the patient’s medical history and other diagnostic laboratory test results.
  • FISH assay results may not be informative if the specimen quality and/or specimen slide preparation is inadequate.
  • Technologists performing the FISH signal enumeration must be capable of visually distinguishing between the orange, green, and yellow signals.

 

Caution

United States Federal law restricts this device to sale and distribution to or on the order of a physician or to a clinical laboratory; and use is restricted to, by, or on the order of a physician.

 

XALKORI® is a registered trademark of Pfizer Inc.

 


Complete Package Insert for Vysis ALK Break Apart FISH Probe Kit

 

 

References:

1. Vysis ALK Break Apart FISH Probes Kit Package Insert 30-608495.

2. Soda M, Choi YL, Enomoto M, et al. Identification of the transforming EML4-ALK fusion gene in non-small-cell lung cancer. Nature. 2007;448:561-567.

3. Kwak EL, Bang Y-J, Camidge DR, et al. Anaplastic lymphoma kinase inhibition in non-small-cell lung cancer. N Engl J Med. 2010;363:1693-1703

4.The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines™) Non-Small Cell Lung Cancer (Version 1.2012). ©2011 National Comprehensive Cancer Network, Inc. Available at http://www.ncn.org.