Roche Gets FDA OK for Mycoplasma Detection Kit | GenomeWeb

NEW YORK (GenomeWeb News) – Roche said today that the US Food and Drug Administration has accepted the use of Roche's PCR-based mycoplasma detection test for release testing of a Roche biopharmaceutical product.

Roche said that its test, called MycoTool, is the first commercially available mycoplasma PCR test accepted by the FDA for release testing of a biopharmaceutical product.

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