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Tm Bioscience Receives CE Mark for Cystic Fibrosis Test

NEW YORK, Jan. 12 (GenomeWeb News) - The European Union approved Tm Bioscience to market its Tag-It Cystic Fibrosis Kit for diagnostic purposes, the company said yesterday.

 

Under the CE Mark, the company can market the genetic test to EU countries and other countries that recognize the designation.

 

The US Food and Drug Administration approved the kit as an in vitro device for diagnostic use.

 

The test detects and identifies mutations and variants in the cystic fibrosis transmembrane conductance regulator gene in human blood or blood spot specimens.

The Scan

Follow-Up Data Requests to Biobank Participants Ineffective, Study Finds

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