Sep. 3, 2009 (Business Wire) -- Luminex Corporation (NASDAQ: LMNX), the worldwide leader in multiplexed solutions, today 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 datei.
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.
Luminex Molecular Diagnostics, a division of Luminex Corporation, is a pioneer in developing qualitative genotyping tests for cystic fibrosis. The xTAG Cystic Fibrosis 39 Kit v2 is the next generation of Luminex’s first groundbreaking 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.
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.
