FDA-approval for Roche’s nucleic acid based (PCR) Rapid Mycoplasma Test (MycoTOOL® PCR Mycoplasma Detection Kit)
![Bioburden - Live Online Training](files/eca/userImages/training.img/Z-ECA-Bioburden-LOT.jpg)
Recommendation
15/16 October 2024
Regulatory Expectations and Practical Experiences
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.
Related GMP News
05.06.2024Handling of Microbiological Deviations and Sterility Testing - FDA publishes Warning Letter
07.05.2024HTS/NGS - Draft Ph.Eur. Chapter "High-Throughput Sequencing for detecting Viral Extraneous Agents"
31.01.2024EMA publishes new questions and answers on Annex 1
21.11.2023Interpretation of Annex 1 - Swissmedic publishes Q&A Document
16.02.2023Pyrogenicity Testing - European Pharmacopoeia continues to be updated
15.02.2023Warning Letter and Recall of a homeopathic Medicine for Children