Tm Bioscience Receives FDA Clearance For Cystic Fibrosis DNA Test
Tm Bioscience Corporation has recently announced that its Tag-It™ Cystic Fibrosis (CF) Kit is the first multiplexed human disease genotyping test to be cleared by the U.S. FDA as an in vitro device (IVD) for diagnostic use in the United States.
This DNA based test is used to simultaneously detect and identify mutations and variants in the cystic fibrosis transmembrane conductance regulator (CFTR) gene in human blood specimens in order to determine CF carrier status in adults, as an aid in newborn screening, and in confirmatory diagnostic testing in newborns and children. Performance testing has established that the Tag-It™ CF Kit operates with 100% accuracy, greater than 99.9% reproducibility and precision.
"Clearance by the FDA of a genetic assay for cystic fibrosis provides a highly standardized product for laboratories that offers tremendous benefits to the genetic testing industry, physicians and to patients." said Dr. Michael Watson, Executive Director, American College of Medical Genetics.
Cystic Fibrosis (CF) is the most common autosomal recessive disorder in the Caucasian population, with an incidence of approximately 1 in 3,200 live births. The Tag-It™ Cystic Fibrosis Kit simultaneously screens for the 23 cystic fibrosis transmembrane conductance regulator (CFTR) gene mutations and 4 variants (polymorphisms), as recommended by the American College of Medical Genetics (ACMG) and the American College of Obstetricians and Gynecologists (ACOG) in 2004. In addition, the kit screens for 16 additional mutations prevalent in North America or the world.
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