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Roche's Rapid Mycoplasma Detection Test MycoTOOL Receives FDA Acceptance for Release Testing of Biopharmaceutical Roche Product

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Roche's Rapid Mycoplasma Detection Test MycoTOOL Receives FDA Acceptance for Release Testing of Biopharmaceutical Roche Product PR Newswire PENZBERG, Germany, December 19, 2012 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.

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Roche's Rapid Mycoplasma Detection Test MycoTOOL
Receives FDA Acceptance for Release Testing of
Biopharmaceutical Roche Product
PR Newswire
PENZBERG, Germany, December 19, 2012
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
contamination.
About Roche
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,
tissuebased 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 : claudia.schmitt.cs2@roche.com