News

New Cystic Fibrosis Test by Luminex receives 510(K) clearance

Austin, Texas, USA
Sep 3, 2009

Luminex Corporation received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for xTAG(R) Cystic Fibrosis 39 Kit v2, a new cystic fibrosis (CF) test. The xTAG Cystic Fibrosis 39 Kit v2 is the next generation of Luminex’s first groundbreaking xTAG Cystic Fibrosis Kit.

The xTAG test detects 39 CF-causing gene mutations. It is used to screen potential parents to determine if they are carriers of CF-causing gene mutations, as an aid in newborn screening and in confirmatory diagnostic testing in newborns and children.

“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, which will assist in improving the health and quality of life of people with CF around the world”, remarked Patrick J. Balthrop, President And Chief Executive Officer, Luminex.