Luminex Corporation announced 510(K) clearance of xTAG Cystic Fibrosis 39 Kit v2 which is a new cystic fibrosis test. The test is used in detection for 39 CF-causing gene mutations and to determine carriers of CF-causing gene mutations by screening potential parents. It aids in newborn screening and in confirmatory diagnostic testing in newborns and children. .
The xTAG Cystic Fibrosis 39 Kit v2 is the successor of Luminex’s xTAG Cystic Fibrosis Kit which was cleared earlier in May 2005. Recommended by the American College of Medical Genetics (ACMG) and American College of Obstetricians and Gynecologists (ACOG), the test screens for the 23 CFTR gene mutations and four variants (polymorphisms)and 16 additional CFTR gene mutations from human blood specimens in a few hours.
The test is flexible, and offers physicians an option to select CFTR gene mutations which they choose to test. They can select to test patient for 23 ACMG/ACOG-recommended gene mutations or the entire panel of 39 CFTR gene mutations.
Wayne W. Grody, M.D., Ph.D., professor in the Departments of Pathology and Laboratory Medicine, Pediatrics, and Human Genetics at the UCLA School of Medicine, recently statedii, “Experienced laboratories now have no trouble handling the core screening panel of 23 mutations, and many use even-larger ‘expanded’ panels for either diagnostic or screening purposes. The ACMG panel was devised and recommended only for population-based carrier screening. It was not intended to also serve as the standard for diagnostic testing in newborn screening; for these purposes, laboratories are free to select panels that examine greater or fewer mutations.”
xTAG Cystic Fibrosis 39 Kit v2 facilitates laboratories to avoid different platforms for various testing purposes and allows to save time and resources. This test does not require reflex testing as the previously cleared test. If necessary, at each run all results are revealed and available for analysis.
To make the test fast and easy to use the protocol for the xTAG Cystic Fibrosis 39 Kit v2 has been streamlined. with less hands-on time for laboratory technicians. The xTAG Cystic Fibrosis 39 Kit v2 is also highly accurate and reproducible with validated performance criteria,
“The xTAG Cystic Fibrosis 39 Kit v2 is establishing a new benchmark for CF testing,” said Patrick J. Balthrop, president and chief executive officer of Luminex. “The first FDA-cleared molecular diagnostic test for cystic fibrosis demonstrated Luminex’s leadership in innovative CF testing. With this improved product, we focused on our customers’ need to have a faster and easier to use IVD-cleared test with broad genetic mutation coverage. The xTAG Cystic Fibrosis 39 Kit v2 gives doctors the ability to quickly, accurately and effectively screen potential parents for CF gene mutations and diagnose the disease early, which will assist in improving the health and quality of life of people with CF around the world.”
Through Luminex Molecular Diagnostics or its channel Fisher HealthCare, the xTAG Cystic Fibrosis 39 Kit v2 is available throughout the US. The test got CE mark approval in June 2009 in Europe.