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Canada Accepts Use of Roche's Mycoplasma Detection Test

NEW YORK (GenomeWeb News) – Roche announced today that the Canadian Health Authority has accepted the use of its mycoplasma detection tool for "release testing" of one of the firm's undisclosed biological products.

It said that the PCR-based test, called MycoTool, which the US Food and Drug Administration accepted for use in December, can replace conventional mycoplasma detection assays based on culture methods and in vitro assays. Such testing methods can take as long as 28 days for results, compared to one day for MycoTool, Roche said.

Mycoplasms frequently are the causes of contamination in biopharmaceutical production, cell therapy, tissue engineering, and vaccine manufacturing, according to Roche. In a statement, Ruedi Stoffel, head of Custom Biotech for Roche, said, "Fast methods, like our new MycoTool test, will greatly enhance the efficiency, quality, and safety in the manufacturing process of pharmaceutical and biological products."

In April 2011, Roche and Lonza announced an exclusive deal for co-distribution of MycoTool.