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Luminex Receives 510(K) Clearance for new Cystic Fibrosis Test

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Luminex Corporation has announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a new cystic fibrosis (CF) test: the xTAG® Cystic Fibrosis 39 Kit v2.

Designed with years of feedback from clinicians and technicians, the newly cleared xTAG test detects for 39 CF-causing gene mutations. It is used to screen potential parents to determine if they are carriers of CF-causing gene mutations, and as an aid in newborn screening and in confirmatory diagnostic testing in newborns and children.

Cystic fibrosis is a chronic inherited genetic disease in which the body produces thick and sticky mucus that can clog the lungs and affect the digestive system. It is caused by mutations in the CF transmembrane conductance regulator (CFTR) gene. More than 1,500 such mutations have been identified to date.

Carrier screening is recommended for couples planning a pregnancy as it is possible for a person to carry a CF-causing gene mutation and have no symptoms of the disease. According to the Cystic Fibrosis Foundation, more than 10 million Americans are symptomless carriers of a CFTR gene mutation. Early diagnosis of CF in newborns and children allows for earlier treatment intervention and can help improve a child’s long-term health and quality of life.

The xTAG Cystic Fibrosis 39 Kit v2 screens for 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), and 16 additional CFTR gene mutations from human blood specimens in a few hours.

The xTAG Cystic Fibrosis 39 Kit v2 is flexible, offering physicians the ability to select the CFTR gene mutations for which they want to test. Doctors can choose to test a patient for the 23 ACMG/ACOG-recommended gene mutations or the entire panel of 39 CFTR gene mutations.

With its flexibility feature, the xTAG Cystic Fibrosis 39 Kit v2 will allow laboratories to avoid having different platforms for various testing purposes and save time and resources. Additionally, like the first generation xTAG CF test, the new xTAG Cystic Fibrosis 39 Kit v2 does not require reflex testing. All results are revealed and available for analysis at each run, if necessary.

The protocol for the xTAG Cystic Fibrosis 39 Kit v2 has been streamlined to make the test easy to use, with less hands-on time for laboratory technicians than any other CF test available.