The comprehensive and flexible cystic fibrosis (CF) test will be used to screen potential parents to determine if they are carriers of CF-causing gene mutations, and as an aid in newborn screening and confirmatory diagnostic testing in newborns and children.

The xTAG Cystic Fibrosis 60 Kit v2 detects CFTR gene mutations including the 23 CFTR gene mutations and four variants (polymorphisms) recommended by the American College of Medical Genetics (ACMG) and American College of Obstetricians and Gynecologists (ACOG); 37 additional common North American mutations, including 20 mutations that are found within Hispanic and African-American populations are also detected

Luminex Corporation (Austin, TX, USA) introduced the xTAG Cystic Fibrosis 60 Kit v2. 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