FDA Clears Roche's LightCycler(R) MRSA Advanced Test for Use in the U.S.

By Roche Molecular Systems Inc., PRNE
Wednesday, July 7, 2010

Easy-to-use molecular test offers faster results to help healthcare facilities control spread of methicillin-resistant Staphylococcus aureus (MRSA)

PLEASANTON, California, July 8, 2010 - Roche Molecular Systems, Inc. (SIX: RO, ROG; OTCQX: RHHBY) announced
today that the U.S. Food & Drug Administration (FDA) cleared its new
LightCycler(R) MRSA Advanced Test for the detection of methicillin-resistant
Staphylococcus aureus (MRSA) for clinical use in the United States. The
LightCycler(R) MRSA Advanced Test is a qualitative in-vitro diagnostic test
for the direct detection of nasal colonization with bacterial MRSA, and it is
designed to aid in the prevention and control of MRSA infections in
healthcare settings. Roche's new real-time polymerase chain reaction (PCR)
test delivers rapid results (within two hours) and appears to have better
sensitivity compared to direct culture-based methods.

"It is important that healthcare professionals have access to MRSA
testing technology that provides rapid and reliable results, allowing faster
implementation of appropriate infection control measures," said Paul Brown,
Ph.D., president and CEO, Roche Molecular Diagnostics. "Roche's new
LightCycler(R) MRSA Advanced Test is designed to offer a simple, flexible,
and reliable method for MRSA screening to support hospitals in the prevention
of MRSA infections."

High rates of infection, mortality, and high costs of treatment due to
healthcare-associated infections (HAIs) caused by MRSA are a critical issue
for healthcare facilities worldwide. In addition, community-associated MRSA
(CA-MRSA) infection has spread in the U.S., feeding the pipeline of infection
in hospitals, and underscoring the need for comprehensive infection control
programs along with more rapid and reliable MRSA screening methods. In
response to this public health issue, an increasing number of states have
passed legislation requiring mandatory reporting and/or screening for HAI's.

"The introduction of this new advanced test will expand the options
healthcare facilities have for MRSA screening using molecular diagnostic
methods," said Lance Peterson, M.D., FASCP, epidemiologist and a founder of
the MRSA screening program at NorthShore University HealthSystem in Evanston,
Illinois
. "The test showed good sensitivity with minimal hands-on time.
Technicians now have the ability to have flexible batch sizes which could
make it the cost-effective choice for many hospital laboratories."

About the Roche LightCycler(R) MRSA Advanced Test

The LightCycler(R) MRSA Advanced Test is performed on Roche's
LightCycler(R) 2.0 Instrument with nasal swab specimens from patients
suspected of MRSA colonization. Offered in a convenient, ready-to-use format
and designed for flexible batch sizes, the test is intended to help ensure
the safety and productivity of laboratory staff and provides flexible
throughput with accurate, reliable results. The combined capabilities of the
LightCycler(R) 2.0 Instrument with the flexible design and reliable detection
of the LightCycler(R) MRSA Advanced Test are intended to provide a versatile,
cost-effective medically valuable tool to support healthcare institutions in
their efforts to prevent and contain the spread of MRSA infection. Roche's
LightCycler(R) 2.0 Instrument remains among the most widely used real-time
amplification systems available worldwide.

About methicillin-resistant Staphylococcus aureus (MRSA)

Methicillin-resistant Staphylococcus aureus (MRSA) is a type of bacterium
that is resistant to certain antibiotics, such as methicillin, oxacillin,
penicillin and amoxicillin. Staphylococcus aureus is one of the most
frequently isolated bacteria from patients with healthcare-associated
infections (HAIs). Estimates suggest that 2 million HAIs and 90,000 deaths
are attributable to these infections each year in the U.S., and that between
5% and 10% of inpatients in U.S. hospitals acquire an HAI.(1)

Antimicrobial resistance and HAIs, either combined or separately,
constitute a major infectious disease problem in the U.S. and show signs of
becoming more prevalent in the future. MRSA infections are a tremendous
burden for healthcare systems and hospitals and are associated with
significant healthcare costs. In 2007, the Centers for Disease Control and
Prevention (CDC) estimated that HAIs were responsible for $4.5 to $5.7
billion
in added healthcare costs each year.(1) Experts generally believe
that at least 20-30% of such infections are preventable, and molecular-based
diagnostic tests to detect HAIs offer faster, sensitive methods to detect
infections and prevent their spread. In the U.S. it is estimated that the
market for molecular-based MRSA screening is estimated to be worth
approximately $125 million in 2010 and growing at 20% per annum.

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 2009, Roche had over 80,000 employees worldwide and invested
almost 10 billion Swiss francs in R&D. The Group posted sales of 49.1 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: www.roche.com.

All trademarks used or mentioned in this release are protected by law.

    For further information please contact:

    April Falcone
    Manager, Product Communications
    Roche Molecular Systems, Inc.
    april.falcone@roche.com
    tel +1-925-699-5606

(1) www.cdc.gov/ncidod/dhqp/pdf/hicpac/infections_deaths.pdf.
Public Health Reports, March-April 2007. Accessed July 2009.

April Falcone, Manager, Product Communications of Roche Molecular Systems, Inc., +1-925-699-5606, april.falcone at roche.com

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