Abbott, Abbott Park, Ill, will expand the current CE-IVD product labeling for its Vysis® ALK Break Apart FISH Probe Kit.
The move will allow Abbott to market the test in the European Union as a companion diagnostic.
The test detects rearrangements of the anaplastic lymphoma kinase (ALK) gene in advanced non-small cell lung cancer (NSCLC) patients who may be eligible for treatment with XALKORI (crizotinib), an oral ALK inhibitor.
The Vysis ALK test kit uses Abbott’s proprietary fluorescence in situ hybridization (FISH) technology. The Abbott test has been used by oncologists in the United States since it was co-approved with XALKORI by the FDA in 2011. The test offers clinicians a standardized, clinically validated method to identify patients more likely to benefit from the new therapy. In Europe, the CE-IVD test has been available to laboratories since September 2011 and has been used primarily in academic studies and to support evaluations of new therapies.
Worldwide, lung malignancies are the leading cause of cancer deaths, with more than 1.6 million new cases diagnosed each year. About 85% of lung cancer patients have the non-small cell type and are usually diagnosed with advanced disease with a very low survival rate. Approximately 3% to 5% of those patients have rearrangements of the ALK gene and will respond to therapies like XALKORI, which block the ALK pathway.
[source: Abbott]
