Tm Bioscience Corporation's Tag-It Cystic Fibrosis (CF) Kit, the first multiplexed human disease genotyping test, will be cleared by the US Food and Drug Administration (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.

Greg Hines, CEO of Tm Bioscience says, "The Tag-It Cystic Fibrosis Kit is the only CF testing system that has performance characteristics which have been established through extensive studies reviewed by the FDA. Having the first CF test and second multiplexed genetic test behind Roche's (RHHBF.PK) AmpliChip CYP450 to be cleared as an IVD, sets the regulatory pathway for other tests in our broad and growing pipeline and positions Tm as a leader in the commercial genetic testing market."

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(tm) 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.