NORTH CHICAGO (dpa-AFX) - Abbott Laboratories (ABT) announced on Friday that it has received approval from the U.S. Food and Drug Administration for a new molecular diagnostic test designed to detect rearrangements of the anaplastic lymphoma kinase or ALK gene in non-small-cell lung cancer or NSCLC. The new Abbott Vysis ALK Break Apart FISH Probe test is designed to identify ALK-positive NSCLC patients for Pfizer's approved NSCLC therapy, Xalkori (crizotinib), an oral first-in-class ALK inhibitor.
The Vysis ALK FISH test uses Abbott's fluorescence in situ hybridization (FISH) technology to detect rearrangements of the ALK gene on the 2p23 chromosome.
The Abbott ALK test has been designed to identify those patients - about 3 to 5 percent of NSCLC patients - who would be candidates for the new drug, the company said.
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