Roche announces launch of cobas® MRSA/SA Test in markets accepting the CE mark
PLEASANTON, California, Jan. 8, 2014
-- New test detects methicillin-resistant Staphylococcus aureus and
Staphylococcus aureus , the leading causes of healthcare acquired infections
PLEASANTON, California, Jan. 8,2014 /PRNewswire/ -- Roche (SIX: RO, ROG;
OTCQX: RHHBY) announced today the CE-IVD launch of the cobas® MRSA/SA Test for
the early, simultaneous detection of methicillin-resistant Staphylococcus
aureus (MRSA) and methicillin-sensitive Staphylococcus aureus (SA) from nasal
specimens. The cobas® MRSA/SA Test detects both organisms from a single
specimen, providing accurate and reliable results for effective prevention and
control of MRSA/SA infections.
With an innovative design to include diverse geographical strain coverage,
coupled with automation on the cobas® 4800 System, the cobas® MRSA/SA Test can
process specimens using one of the fastest, most advanced real-time polymerase
chain reaction (PCR) amplification and detection available today.
"The fight against healthcare associated infections (HAIs) continues to
develop. Successful initiatives have led to a decrease in the rate of MRSA in
many institutions, requiring optimal sensitivity and specificity for
identifying true carriers, said Prof. Dr. Udo Reischl, Institute of Medical
Microbiology and Hygiene, University Hospital Regensburg. "The cobas® MRSA/SA
Test demonstrates excellent performance in detecting diverse MRSA strains from
around the world, which provides confidence in identifying infected patients
the first time they are evaluated."
"With the addition of the cobas® MRSA/SA Test, Roche offers clinicians a
sustainable molecular test that will aid in the overall management of
hospital-acquired infections," said Paul Brown, Head of Roche Molecular
Diagnostics. "The cobas® MRSA/SA Test combines laboratory procedures with
automation, which provides labs with a simplified workflow through primary
vial loading. This approach requires less hands-on time and reduces the chance
of error, which leads to better patient management."
The test is performed on the cobas® 4800 System, currently the only CE-IVD
marked system that offers the flexibility to run sexually transmitted
infection and HAI tests, in the same run, on a single platform. The
streamlined workflow can help labs reduce costs, improve turnaround time and
enable staff to spend time on other critical tasks.
About methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus
aureus (SA) Approximately one third of the population carries Staphylococcus
aureus as normal flora in the anterior nares, which can lead to opportunistic
infections. Staphylococcus aureus has evolved resistance mechanisms due to
frequent exposure to antibiotics in health care settings. Recent reports show
up to 85% of invasive MRSA infections identified as health care acquired,
resulting in over 90,000 infections and 18000 deaths in 2005 alone ^ .
Surgical site infections, ventilator assisted pneumonia, and blood stream
infections attributed to colonized central lines are the most frequent
manifestations of disease. Active surveillance to identify carriers is helping
to mitigate the potential consequences of disease, providing relief to
patients and healthcare institutions facing the challenges of escalating
About the cobas 4800 System The cobas® 4800 System offers true walk-away
automation of nucleic acid purification, PCR set-up and real-time PCR
amplification and detection to help laboratories achieve maximum efficiency.
The expanding system menu currently includes the cobas® HSV 1 and 2 Test,
cobas® CT/NG Test (chlamydia/gonorrhea), cobas® HPV Test, cobas® BRAF V600
Mutation Test and the cobas® EGFR Mutation Test.
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, infectious diseases, inflammation,
metabolism and neuroscience. Roche is also the world leader in in vitro
diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes
management. Roche's personalised healthcare strategy aims at providing
medicines and diagnostic tools that enable tangible improvements in the
health, quality of life and survival of patients. In 2012 Roche had over
82,000 employees worldwide and invested over 8 billion Swiss francs in R&D.
The Group posted sales of 45.5 billion Swiss francs. Genentech, in the United
States, is a wholly owned member of the Roche Group. Roche is the majority
shareholder in Chugai Pharmaceutical, Japan. For more information, please
visit www.roche.com .
. Klevens et al. Invasive Methicillin-Resistant Staphylococcus aureus
Infections in the United States. JAMA. 2007;298:63–1771
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