FDA approves Abbott's Vysis ALK FISH test for NSCLC therapy selection

Abbott (NYSE: ABT) today announced it has received approval from the U.S. Food and Drug Administration (FDA) for a new molecular diagnostic test designed to detect rearrangements of the anaplastic lymphoma kinase (ALK) gene in non-small-cell lung cancer (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 diagnostic test offers clinicians a standardized, clinically validated method to identify patients more likely to benefit from the new therapy.

"The Abbott-Pfizer collaboration marks a breakthrough in the advancement of personalized medicine – and companion diagnostics specifically – that will help a subset of lung-cancer patients get treatment tailored to their unique genetic profile," said Stafford O'Kelly, head of Abbott's molecular diagnostics business.  

The simultaneous FDA approvals are expected to change clinical practice for the diagnosis and treatment of patients with NSCLC. 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 FDA's priority and expedited review process of the drug and combination diagnostic test have been impressive," O'Kelly said. "We expect that many patients newly diagnosed with NSCLC will want to ask their doctors about the potential benefits of this new genetic test."