Abbott Laboratories (ABT) Wednesday said 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 gene in advanced non-small cell lung cancer patients who may be eligible for treatment with Pfizer's Xalkori, an oral first-in-class ALK inhibitor.
The Vysis ALK test kit uses Abbott's proprietary fluorescence in situ hybridization technology and was the only diagnostic test used in multi-center global clinical trials in conjunction with Xalkori.
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December 12, 2025 15:14 ET Central bank decisions dominated the economic news flow this week led by the Federal Reserve. Trade data from the U.S. also gained attention. The Canadian and Swiss central banks also announced their interest rate decisions. Inflation data from China was in focus as the country released the latest consumer price and producer price data.