Tm Bioscience cystic fibrosis kit obtains CE Mark

By Lisa Kerner

Erie, Pa., Jan. 11 - Tm Bioscience Corp. announced that its Tag-It Cystic Fibrosis (CF) Kit now has the CE Mark. This allows the genetic test to be marketed for diagnostic purposes in the European Union and other countries that recognize the CE Mark.

"Having the CE Mark on our Tag-It CF test expands our reach into the European market for CF testing and further asserts our leadership position in the clinical genetic testing market," Greg Hines, president and chief executive officer of Tm Bioscience said in a company news release.

The Tag-It CF Kit is used to detect and identify 39 mutations and 4 variants in human blood. The kit determines CF carrier status in adults and is used in newborn screening and diagnostic test confirmation.

Cystic Fibrosis is the most common autosomal recessive disorder in the Caucasian population, with an incidence of approximately 1 in 3,200 live births.

Performance testing indicates that the Tag-It CF Kit operates with 100% accuracy and greater than 99.9% reproducibility and precision, said the company. The Tag-It CF Kit is the first multiplexed human disease genotyping test to be cleared by the U.S. Food and Drug Administration as an in vitro device for diagnostic use in the United States.

Tm Bioscience, based in Toronto, is a DNA-based diagnostics company developing genetic tests for genetic disorders, drug metabolism, and infectious diseases.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.