Abbott Laboratories (ABT) Wednesday said it will expand the current CE-IVD product labeling for its Vysis ALK Break Apart FISH Probe Kit, allowing the test to be marketed in the European Union as a companion diagnostic.
The test is designed to detect rearrangements of the anaplastic lymphoma kinase gene in advanced non-small cell lung cancer patients who may be eligible for treatment with Pfizer's Xalkori, an oral first-in-class ALK inhibitor.
The Vysis ALK test kit uses Abbott's proprietary fluorescence in situ hybridization technology and was the only diagnostic test used in multi-center global clinical trials in conjunction with Xalkori.
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