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Tm Bioscience's CF test:

This article was originally published in Clinica

Executive Summary

Tm Bioscience has CE-marked for sale in Europe its molecular blood test for cystic fibrosis (CF). The Tag-It CF kit, which is already available in the US, can be used for carrier screening and for diagnosing newborns. Performance testing has established that the kit operates with 100% accuracy and greater than 99.9% reproducibility and precision, said the Toronto, Canada-based firm. In a separate announcement, Tm Bioscience said it had launched for research-use only its ID-Tag test for 21 respiratory viruses, including avian flu. "We intend to continue clinical validation activities and advance this product through the IVD clearance process in North America and internationally," said Greg Hines, the firm's president and CEO.

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