FDA Grants Luminex 510(k) Clearance for Cystic Fibrosis Test

dnaLuminex Corporation, a developer of testing technologies, has received 510(k) clearance from the U.S. Food and Drug Administration for a new cystic fibrosis (CF) test. The xTAG Cystic Fibrosis 39 Kit v2 is designed to screen potential parents to determine whether they carry the genetic mutations that cause CF. Approximately 10 million people carry a CF-causing mutation, but have no symptoms themselves. The test can also aid in screening newborns and confirming diagnosis in children. Early intervention is critical in extending the lives of CF patients.

Cystic fibrosis is a chronic condition caused by mutations in the CF transmembrane conductance regulator (CFTR) gene. The body produces thick, sticky mucus that clogs the lungs and causes digestive problems. Patients may develop life-threatening lung infections. According to the Cystic Fibrosis Foundation, about 30,000 people in the U.S. suffer from CF. More than 70 percent of CF cases are diagnosed by age 2. The disease was a death sentence for children in the 1950s. However, new treatment options have helped CF sufferers live well into adulthood. 

The xTAG Cystic Fibrosis 39 Kit v2 is intended to be a faster, more convenient way to screen for CF. It screens for 39 different CTFR gene mutations. Luminex says that the test does away with the need for different testing platforms, saving laboratories time and resources. Results can arrive within a few hours.

In June, the Austin, Tx.-based company launched two new cystic fibrosis tests in Europe. Two other companies developing CF screenings and diagnostics are Celera Diagnostics and Nanogen. Companies working on therapeutics for CF include Aridis, NatImmune, and Aerovance.

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