How the ALK FISH diagnostic works to identify patients who may benefit from ALK-directed therapy
The ALK gene rearrangements define a novel subclass of NSCLC1-3:
- Involve a gene fusion between ALK and the promoter region of another gene1
- ALK can partner with several genes including EML4, TFG, and KIF5B1,4
- Breakpoints in EML4 can vary, while the breakpoint in ALK is consistent1,4,5
Vysis ALK dual color, break apart rearrangement probes:
Early FISH testing at diagnosis can assist physicians in determining appropriate ALK-directed therapy
Vysis ALK is a FISH-based test that is intended for all NSCLC tissue specimens, including not otherwise specified (NOS) specimens.
Sample Type for Vysis ALK
Lung cancer tissue specimens fixed in formalin are required for the Vysis ALK Test.
- The specimen should be obtained by a surgeon, ideally under the supervision of the pathologist.
- Sufficient specimen should be obtained during a single surgical procedure for the range of tests that the pathologist may order.
1. 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
2. Horn L, Pao W. EML4-ALK: honing in on a new target in non-small-cell lung cancer. J Clin Oncol. 2009;27:4232-4235
3. Shaw AT, Yeap BY, Mino-Kenudson M, et al. Clinical features and outcome of patients with non-small-cell lung cancer who harbor EML4-ALK. J
Clin Oncol. 2009;27:4247-4253
4. Vysis ALK Break Apart FISH Probes Kit Package Insert 30-608495
5. 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