FDA grants approval for Abbott’s ALK Gene Test

Abbott (NYSE: ABT) announced that a new molecular diagnostic test has been approved by the U.S. Food and Drug Administration (FDA). The test is designed to identify reshuffling of the anaplastic lymphoma kinase (ALK) gene in non-small-cell lung cancer (NSCLC). The Vysis ALK Break Apart FISH Probe test by Abbott identifies ALK-positive NSCLC patients for an approved NSCLC therapy, XALKORI® (crizotinib), by Pfizer. XALKORI is an oral first-in-class ALK inhibitor.

The Vysis ALK FISH test comprising Abbott’s fluorescence in situ hybridization (FISH) technology detects the rearrangements of the ALK gene on the 2p23 chromosome. Patients likely to benefit from the new therapy can be easily identified through a standardized, clinically validated method offered by the diagnostic test.

Head of Abbott’s molecular diagnostics business, Stafford O’Kelly, says: “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.”

Clinical practice for the diagnosis and treatment of NSCLC patients is expected to change with the concurrent FDA approvals of the test and new drug. About 3 to 5 percent of NSCLC patients who could be potential candidates for the new drug can be identified with the ALK test.

O’Kelly said, “The FDA’s priority and expedited review process of the drug and combination diagnostic test have been impressive. We expect that many patients newly diagnosed with NSCLC will want to ask their doctors about the potential benefits of this new genetic test.”

Globally, malignant lung cancers are the key causes of cancer-related fatalities with over 1.6 million new diagnoses each year. Nearly 85% lung cancers are of the non-small-cell type, and patients with this type of cancer have poor survival rate as the disease is usually diagnosed at an advanced stage.

About FISH: FISH (fluorescence in-situ hybridization) technology can be exploited for a variety of purposes including the detection of the numbers of copies (too many or too few) of a particular gene in the body’s cells or the identification of gene rearrangements responsible for disease progression. FISH technology is extensively explored in cancer diagnostics because it works exceptionally well for identifying genetic markers in solid tumors.