Vysis ALK Performance
Vysis ALK, a FISH-based test, is the first molecular diagnostic test approved by the FDA to aid in identifying the ALK status of patients with NSCLC. The sensitivity and specificity of Vysis ALK have been analyzed, as shown in the FDA-approved labeling.1
Why Order Vysis ALK?
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 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 helps pathologists and oncologists to diagnose and appropriately manage their NSCLC patients
ALK Test Comparison
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.