Blood Sample Screened for Cystic Fibrosis-Causing Mutations

The test recently received 510(k) clearance from the U.S. Food and Drug Administration (FDA; Silver Spring, MD, USA).

"The launch of our new xTAG Cystic Fibrosis 60 Kit v2 is a great achievement in cystic fibrosis testing," said Patrick J. Balthrop, president and CEO of Luminex. "This cleared test has the most comprehensive genetic mutation coverage available today, featuring mutations found among Caucasians as well as those that are more commonly found in other ethnic populations. It will give doctors the ability to screen children and potential parents of many ethnicities for CF."

CF is caused by mutations in the CF transmembrane conductance regulator (CFTR) gene. To date, more than 1,500 of these mutations have been discovered. More than 10 million Americans are symptomless carriers of CF-causing gene mutations and approximately 30,000 Americans suffer from the condition. It is a common genetic disorder that causes the body to produce thick mucus that can clog the lungs and affect the digestive system.

Luminex Corporation develops, manufactures, and markets biologic testing technologies with applications throughout the diagnostic and life sciences industries.

Related Links:
American College of Medical Genetics
American College of Obstetricians and Gynecologists
Luminex Corporation
U.S. Food and Drug Administration