FDA-approval for Roche’s nucleic acid based (PCR) Rapid Mycoplasma Test (MycoTOOL® PCR Mycoplasma Detection Kit)

On November 1st, 2012, the MycoTOOL® PCR Mycoplasma Detection Kit-based test from Roche Applied Science was approved by the U.S. Food and Drug Administration (FDA) for release testing of a  Roche biopharmaceutical product. It is the first commercially available Mycoplasma PCR test approved by FDA that can replace conventional and time-consuming mycoplasma detection assays (culture method as well as indicator cell culture method) for the testing of biologics and biopharmaceuticals.

In the past three years Roche’s nucleic acid based (PCR) rapid mycoplasma test has been approved by the European Medicines Agency (EMA), the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) and more than 100 additional Health Authorities worldwide as a Mycoplasma PCR test for release testing of several biopharmaceutical products. The MycoTOOL® PCR Mycoplasma Detection Kit providing all critical reagents for performing an easy to use sample preparation and PCR is globally available for use.

On this occasion, an additional lecture about the MycoTool and the way to get the approval was added to the agenda of the Rapid Microbiological Methods Conference on 11 and 12 December 2013 in Munich.