The test is the most comprehensive and flexible FDA-cleared cystic fibrosis (CF) test available, featuring an unsurpassed level of gene mutation coverage. It will be 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 test recently received 510(k) clearance from the U.S. Food and Drug Administration (FDA).
"The launch of our new xTAG Cystic Fibrosis 60 Kit v2 is a great achievement in cystic fibrosis testing," said Patrick J. Balthrop, president and chief executive officer of Luminex. "This cleared test has the most comprehensive genetic mutation coverage available today, featuring mutations found among Caucasians as well as those that are more commonly found in other ethnic populations. It will give doctors the ability to screen children and potential parents of many ethnicities for CF."
Cystic fibrosis is a common genetic disorder that causes the body to produce thick mucus that can clog the lungs and affect the digestive system. Approximately 30,000 Americans have cystic fibrosis. Although CF is most common in those of Caucasian descent, it can affect people of any race or ethnicity.
CF is caused by mutations in the CF transmembrane conductance regulator (CFTR) gene. To date, more than 1,500 of these mutations have been discovered. CF can only be passed onto a child when both parents carry a gene that causes the disease. According to the Cystic Fibrosis Foundation, more than 10 million Americans are symptomless carriers of CF-causing gene mutations.
Early diagnosis of CF is important and studies have demonstrated that early treatment and intervention can reduce a child's therapeutic needs, lower rates of medical complications, increase life expectancy and improve overall quality of life. Late diagnosis of cystic fibrosis can lead to health complications, chronic lung infections and compromised growth.
The xTAG Cystic Fibrosis 60 Kit v2 can detect up to 60 CFTR gene mutations from a single patient blood sample. These mutations include 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), as well as 37 additional common North American mutations, including 20 mutations that are found within Hispanic and African-American populations.
The xTAG Cystic Fibrosis 60 Kit v2 is flexible. It gives physicians the ability to select the mutations for which they want to test, allowing them to choose to test a patient for the ACMG/ACOG-recommended gene mutations or the entire panel of 60 CFTR gene mutations.
The test also is easy to use and requires only about one hour of hands-on time to process 48 purified samples. Additionally, the xTAG Cystic Fibrosis 60 Kit v2 does not require reflex testing. All test results are revealed and available for analysis at each run.
The xTAG Cystic Fibrosis 60 Kit v2 is one of a suite of CF tests developed by Luminex. The xTAG Cystic Fibrosis 39 Kit v2, which can simultaneously screen a single blood sample for up to 39 cystic fibrosis-causing gene mutations, is available throughout the U.S., Europe and Canada. The test is also cleared by FDA and was launched as a CE marked IVD product under the European Directive on In Vitro Diagnostic Medical Devices in 2009. It received clearance from Health Canada in 2010.
The xTAG Cystic Fibrosis 71 Kit v2, which can simultaneously screen a single blood sample for up to 71 cystic fibrosis-causing gene mutations, is available in Europe and Canada. The test became a CE marked IVD product in 2009 and was cleared by Health Canada in 2010.
The xTAG Cystic Fibrosis 60 Kit v2 will be available throughout the United States through Luminex Molecular Diagnostics or Fisher HealthCare, part of Thermo Fisher Scientific, Inc.
Luminex Corporation (Nasdaq: LMNX), the worldwide leader in multiplexed solutions, today announced the full commercial launch of its xTAG® Cystic Fibrosis 60 Kit v2, a new diagnostic test that can simultaneously screen a single blood sample for up to 60 cystic fibrosis-causing genetic mutations in a matter of hours.