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

 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 (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, 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: claudia.schmitt.cs2@roche.com
 
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