Roche's Mycotool is available for use as a Mycoplasma PCR release test for pharmaceutical products.
The company said that it is the first commercially available Mycoplasma PCR test that can replace traditional Mycoplasma tests (culture method as well as indicator cell culture method) during pharmaceutical production.
The test kit provides all critical reagents for performing a sample preparation and PCR.
Using reagents guaranteed to be nucleic-acid free, the design and production processes for the Mycotool are monitored via change-control notification within the Roche quality system.