Luminex Corp announces that it has received 510(k) clearance from the 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 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, MD, PhD, professor in the Departments of Pathology and Laboratory Medicine, Pediatrics, and Human Genetics at the UCLA School of Medicine, recently stated.
“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.”
With its unique 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.
“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.”
Approximately 70,000 people worldwide, 30,000 of whom live in the United States, have cystic fibrosis. CF can have debilitating and potentially life-threatening consequences. Late diagnosis of the disease is associated with chronic lung infections and compromised growth, whereas early detection and treatment has been shown to reduce therapeutic needs, lower rates of complications and increase life expectancy.
The xTAG Cystic Fibrosis 39 Kit v2 is available throughout the United States through Luminex Molecular Diagnostics or its channel Fisher HealthCare, part of Thermo Fisher Scientific, Inc. In Europe, the test was CE marked in June 2009. The kit is available outside the United States through Luminex Molecular Diagnostics (some regulation restrictions may apply).
Source: Luminex
