FDA OK for Luminex's cystic fibrosis test
This article was originally published in Clinica
Executive Summary
The US FDA has granted 510(k) clearance for Luminex's xTAG Cystic Fibrosis 39 Kit v2. The test detects 39 genetic mutations which cause cystic fibrosis (CF), and is used to assess whether couples planning a pregnancy are carriers of these variants, and also to screen newborn children. More than 10 million Americans are asymptomatic carriers of a CF-causing mutation, according to the Cystic Fibrosis Foundation. The diagnostic is an updated version of Luminex's (Austin, Texas) xTAG Cystic Fibrosis Kit, which received FDA clearance in May 2005. CF is a chronic inherited disease that is caused by mutations in the CF transmembrance conductance regulator (CFTR) gene.