Luminex Receives 510(K) Clearance For New Cystic Fibrosis Test

Luminex has announced that it has received 510(k) clearance from the FDA for a new cystic fibrosis (CF) test; the xTAG Cystic Fibrosis 39 Kit v2.

The company claims, 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.

The xTAG Cystic Fibrosis 39 Kit v2 is the next generation of Luminex’s first xTAG Cystic Fibrosis Kit that was first cleared by the FDA in May 2005. 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 uniquely 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 fast and easy to use, with less hands-on time for laboratory technicians than any other CF test available. With validated performance criteria, the xTAG Cystic Fibrosis 39 Kit v2 is also highly accurate and reproducible.