Luminex Corporation announced that it has launched two new cystic fibrosis (CF) tests in Europe, the xTAG Cystic Fibrosis 39 Kit v2 and xTAG Cystic Fibrosis 71 Kit v2, as CE IVD Marked products under the European Directive on In Vitro Diagnostic Medical Devices.
The novel xTAG tests will be used to provide assistance in cystic fibrosis screening for newborns and confirmatory diagnostic testing in newborns and children. The tests also can be used for carrier testing in adults of reproductive age.
“The geographic distribution of CFTR gene mutations differs significantly among the European populations,” said Prof. Milan Macek, Professor of Medical and Molecular Genetics, Division of Clinical Molecular Genetics and the National Cystic Fibrosis Centre at University Hospital Motol and 2nd School of Medicine Charles University Prague. “Some are ubiquitous, some are rare and some are population-specific. The possibility of having a test that can cover a wide range of mutations found in different ethnic groups is very important and will allow doctors to have better confidence around CF diagnosis, especially when we have cases where the ethnicity of the patient is difficult to assess.”
The xTAG Cystic Fibrosis 39 Kit v2 can quickly and accurately detect up to 39 of the most common CFTR gene mutations from a child or parent’s blood sample or bloodspot in a matter of hours. The xTAG Cystic Fibrosis 71 Kit v2 can screen for all of the genetic mutations in the xTAG Cystic Fibrosis 39 Kit v2 plus an additional 32 mutations including those that are typically found in specific ethnic populations.
The xTAG tests also are uniquely designed to be fast and easy for use, requiring only about one hour of hands-on time to process 48 purified samples. They offer physicians the ability to select the CFTR gene mutations for which they want to test. Additionally, reflex tests are incorporated in these kits. All results are revealed and available for analysis at each run. With validated performance criteria, the xTAG Cystic Fibrosis 39 Kit v2 and xTAG Cystic Fibrosis 71 Kit v2 are highly accurate and reproducible.
“The xTAG Cystic Fibrosis 39 Kit v2 and xTAG Cystic Fibrosis 71 Kit v2 will be important new tools for physicians in Europe by establishing a new benchmark for CF testing. These tests feature broader mutation coverage than any other tests,” said Patrick J. Balthrop, president and chief executive officer of Luminex. “This broad mutation coverage means that more people at risk for CF or at risk for passing CF onto their children will be identified. More comprehensive screening is an essential step in improving the health and quality of life of people with CF.”