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Abbott Vysis ALK Gene test wins FDA nod

Abbott has received the US Food and Drug Administration (FDA) approval for its Vysis ALK Gene test to detect re-arrangements of the anaplastic lymphoma kinase (ALK) gene in non-small-cell lung cancer (NSCLC).

The 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 test uaes Abbott’s fluorescence in situ hybridization (FISH) technology to detect rearrangements of the ALK gene on the 2p23 chromosome.

Abbott molecular diagnostics business head Stafford Kelly said the Abbott-Pfizer collaboration marks an advancement in personalized medicine and companion diagnostics that will help a subset of lung-cancer patients get treatment tailored to their unique genetic profile.