Abbott will expand the current CE-IVD product labeling for its Vysis ALK Break Apart FISH Probe Kit to allow the test to be marketed in the European Union as a companion diagnostic.
The test uses Abbott's proprietary fluorescence in situ hybridization (FISH) technology to detect rearrangements of the anaplastic lymphoma kinase (ALK) gene in advanced non-small cell lung cancer (NSCLC) patients eligible for treatment with Xalkori, an oral first-in-class ALK inhibitor.
Abbott molecular diagnostics business Europe head Kristina Rodnikova said, "Laboratories throughout Europe are familiar with and experienced in using the Vysis ALK FISH test so they will be able to start testing lung cancer patients immediately to help doctors decide if XALKORI is the right treatment option for them."
FISH technology helps identify the role of particular gene or certain genes that play an active role in disease progression.
