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Luminex Gets FDA OK for Second-Generation CF Test

NEW YORK (GenomeWeb News) – Luminex announced after the market closed Thursday that it has received US Food and Drug Administration clearance for its second-generation cystic fibrosis test.

The xTAG Cystic Fibrosis 39 Kit v2 detects 39 CF-causing gene mutations. It is used to screen potential parents to determine if they are carriers of the CF-causing gene mutations, and also can be used as an aid in newborn screening and in confirmatory diagnostic testing in newborns and children, said Luminex.

The new assay screens for the 23 CFTR gene mutations and four variants recommended by the American College of Medical Genetics and the American College of Obstetricians and Gynecologists, and 16 additional CFTR gene mutations from human blood specimens. The test can return results in a few hours, said Luminex.

"With this improved product, we focused on our customers' need to have a faster and easier to use IVD-cleared test with broad genetic mutation coverage," Luminex President and CEO Patrick Balthrop said in a statement. "The xTAG Cystic Fibrosis 39 Kit v2 gives doctors the ability to quickly, accurately and effectively screen potential parents for CF gene mutations and diagnose the disease early."

The initial xTAG CF test was cleared by FDA in May 2005. It also detected 39 mutations, but the new test is faster, more streamlined, and flexible, according to Luminex.

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