Tm Bioscience Cystic Fibrosis test now has CE mark


Tm Bioscience Corporation announced that its Tag-It(TM) cystic fibrosis (CF) Kit now has the CE Mark ("Conformité Européene"), allowing the genetic test to be marketed for diagnostic purposes in the European Union and other countries that recognize the CE Mark.

The Tag-It(TM) Cystic Fibrosis Kit is used to simultaneously detect and identify mutations and variants in the cystic fibrosis transmembrane conductance regulator (CFTR) gene in human blood or blood spot 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(TM) CF Kit operates with 100% accuracy and greater than 99.9% reproducibility and precision.

The Tag-It(TM) Cystic Fibrosis (CF) Kit is also the first multiplexed human disease genotyping test to be cleared by the U.S. Food and Drug Administration (FDA) as an in vitro device (IVD) for diagnostic use in the United States.

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