Abbott's ALK Test Now Available in Europe as a Companion Diagnostic Test for Identifying Patients Eligible for Targeted Lung Cancer Therapy

Abbott announced today that it will expand the current CE-IVD product labeling for its Vysis® ALK Break Apart FISH Probe Kit, allowing the test to be marketed in the European Union as a companion diagnostic. The test is designed to detect rearrangements of the anaplastic lymphoma kinase (ALK) gene in advanced non-small cell lung cancer (NSCLC) patients who may be eligible for treatment with XALKORI (crizotinib), an oral first-in-class ALK inhibitor.

The Vysis ALK test kit uses Abbott's proprietary fluorescence in situ hybridization (FISH) technology and to detect possible gene rearrangements and allow physicians to make important treatment decisions. The test has been used by oncologists in the United States since it was co-approved with XALKORI by the U.S. Food and Drug Administration in August 2011. The test offers clinicians a standardized, clinically validated method to identify patients more likely to benefit from the new therapy. In Europe, the CE-IVD test has been available to laboratories since September 2011 and has been used primarily in academic studies and to support evaluations of new therapies.

"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," said Kristina Rodnikova, head of Abbott's molecular diagnostics business in Europe.

A year of clinical laboratory experience since its approval in the United States has established the Vysis ALK Break Apart FISH assay as a rapid, sensitive and specific test for detecting ALK gene rearrangements in patients with NSCLC. Worldwide, lung malignancies are the leading cause of cancer deaths, with more than 1.6 million new cases diagnosed each year. About 85 percent of lung cancer patients have the non-small cell type and are usually diagnosed with advanced disease with a very low survival rate. Approximately 3 to 5 percent of those patients have rearrangements of the ALK gene and will respond to therapies like XALKORI, which block the ALK pathway.