Roche’s Rapid Mycoplasma Detection Test MycoTOOL Receives FDA Acceptance for Release Testing of Biopharmaceutical Roche Product
PENZBERG, Germany, December 19, 2012 /PRNewswire/ –
First commercially available mycoplasma PCR test accepted by FDA reduces time for
detection from one month to one day
Today Roche announced that the U.S. Food and Drug Administration (FDA) has accepted
the use of its PCR based mycoplasma detection test MycoTOOL for release testing of one of
Roche’s biological products. It is the first commercially available mycoplasma PCR test
accepted by the FDA for release testing of a biopharmaceutical product that can replace
conventional and time-consuming mycoplasma detection assays based on culture methods.
Mycoplasms are frequent causes of contamination in biopharmaceutical production, cell
therapy, tissue engineering and vaccine manufacturing. Traditional detection methods,
required by Pharmacopoeias and drug regulating agencies worldwide, use growth on culture
media and in vitro assays to detect contaminating organisms. Requiring as much as 28 days
to complete, these growth-based methods are time-consuming, making them laborious and
difficult to interpret.
“Mycoplasma contamination represents a significant issue during biological drug
production,” said Ruedi Stoffel, Head of Custom Biotech at Roche. “Fast methods, like our
new MycoTOOL test, will greatly enhance the efficiency, quality and safety in the
manufacturing process of pharmaceutical and biological products.”
On the occasion of the acceptance, an additional lecture about the MycoTool test was
added to the agenda of the Rapid Microbiological Methods Conference taking place on 11 and
12 December 2013 in Munich.
About the MycoTOOL PCR Mycoplasma Detection Kit
The MycoTOOL PCR Mycoplasma Detection Kit provides all critical reagents for
performing an easy to use sample preparation and PCR. It offers a high sensitivity (<1
CFU/ml for most isolates) and is compatible with a diverse spectrum of sample types as
cellular matrices (Human cells, primary and continuous), canine cells, nonhuman primate
cells, many different rodent cell types and cell-free matrices (culture supernatants of
CHO or human stem cells, egg derived samples). It detects the broad panel of Mollicute
species too, including over 150 species due to universal primer design (e.g. Mycoplasma,
Spiroplasma, and Acholeplasma).
The test also minimizes the risk of false negative and false positive test results:
lysis controls of the matrix eliminate the risk of undetected intracellular Mycoplasma and
positive controls verify potential PCR inhibition. Nucleic acid free reagents also prevent
false positives and the use of uracil-DNA glycosylase minimizes the risk of PCR carryover
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare
with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest
biotech company with truly differentiated medicines in oncology, virology, inflammation,
metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based
cancer diagnostics and a pioneer in diabetes management. Roche’s personalized healthcare
strategy aims at providing medicines and diagnostic tools that enable tangible
improvements in the health, quality of life and survival of patients. In 2011, Roche had
over 80,000 employees worldwide and invested over 8 billion Swiss francs in R&D. The Group
posted sales of 42.5 billion Swiss francs. Genentech, United States, is a wholly owned
member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For
more information: http://www.roche.com.
For life science research only. Not for use in diagnostic procedures.
MYCOTOOL is a trademark of Roche.
All other product names and trademarks are the property of their respective owners.
For further information please contact: Roche Diagnostics Dr. Claudia Schmitt Phone: +49-8856-60-10210 Email : firstname.lastname@example.org
SOURCE Roche Diagnostics