Roche announces launch of cobas^® MRSA/SA Test in markets accepting the CE mark

Pleasanton, California

January 8, 2014

New test detects methicillin-resistant Staphylococcus aureus and Staphylococcus aureus, the leading causes of healthcare-acquired infections worldwide.

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 healthcare settings. Recent reports show up to 85 percent of invasive MRSA infections identified as healthcare acquired, resulting in over 90,000 infections and 18,000 deaths in 2005 alone.¹ Surgical site infections, ventilator-assisted pneumonia and bloodstream infections attributed to colonized central lines are the most frequent manifestations of a disease. Active surveillance to identify carriers is helping to mitigate the potential consequences of the disease, providing relief to patients and healthcare institutions facing the challenges of escalating costs.

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 vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner 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 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.

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