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Roche receives FDA clearance for next generation cobas MRSA/SA Test

PLEASANTON, Calif. – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the US Food and Drug Administration (FDA) has provided 510(k) clearance for the cobas® MRSA/SA Test for the early, simultaneous detection of methicillin-resistant Staphylococcus aureus (MRSA) and methicillin-sensitive Staphylococcus aureus (SA) directly 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.

“Numerous successful surveillance programs have led to a significant decrease in the rate of MRSA clinical infection in many organizations, and a dramatic reduction in postoperative surgical infections when screening for SA is done.  Importantly, the fight against healthcare-associated infections continues to advance, as evidenced by this new test that can rapidly detect both MRSA and SA in a single assay,” said Lance R. Peterson, MD, Director of Microbiology and Infectious Diseases Research at NorthShore University HealthSystem and Clinical Professor of Pathology and Medicine at the University of Chicago, Pritzker School of Medicine. “The cobas® MRSA/SA Test demonstrated excellent performance in detecting both MRSA and SA strains in samples collected throughout the US. Compared to culture testing, the cobas® MRSA/SA Test offers confidence in identifying colonized patients the first time they are evaluated, aiding in the prevention of MRSA disease and post-operative SA surgical infections.”

“Healthcare-associated infections continue to be a leading cause of mortality in US medical settings,” said Paul Brown, Head of Roche Molecular Diagnostics. “With the addition of the cobas® MRSA/SA Test to our expanding menu of tests for the cobas® 4800 System,  Roche offers laboratories and clinicians a highly efficient molecular solution to aid in the overall management and prevention of healthcare-associated infections, leading to lower costs for hospitals and optimal patient care.”

The cobas® MRSA/SA Test, a polymerase chain reaction (PCR)-based assay that runs on the automated cobas® 4800 System, offers labs the most simplified workflow available with a simple de-cap and loading of the primary sample vial onto the cobas® 4800 System. This approach requires less hands-on-time, enabling laboratory staff to spend time on other critical tasks. In addition, this streamlined workflow can help labs reduce costs and improve turnaround time.

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 healthcare-associated, resulting in over 90,000 infections and 18,000 deaths in 2005 alone1. 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 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 in the U.S. currently includes the cobas® CT/NG Test (chlamydia/gonorrhea), cobas HPV Test, cobas BRAF V600 Mutation Test and 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.

1. Klevens et al. Invasive Methicillin-Resistant Staphylococcus aureus Infections in the United States. JAMA. 2007;298:63–1771

Source: Roche

Roche acquires Trophos to expand portfolio in neuromuscular disease with high medical need

Swiss drugmaker Roche has signed an agreement to acquire privately-held Trophos for up to $545 million.

The acquisition will provide Roche with Trophos’ candidate for the rare and debilitating spinal muscular atrophy (SMA). Trophos’ proprietary screening platform generated olesoxime (TRO19622), which is in mid-stage development for SMA. SMA is a life-limiting and highly disabling genetic disease characterized by progressive muscle weakness and loss of motor function. It affects the motor neurons of the voluntary muscles used for activities like crawling, walking, head and neck control and swallowing. Typically the disease presents in early childhood, and is the most common genetic cause of infant mortality. SMA affects one in 6,000 to one in 10,000 children.

Results from a Phase II study of Trophos’ olesoxime in SMA showed a beneficial effect on the maintenance of neuromuscular function in individuals with Type II and non-ambulatory Type III SMA, as well as a reduction in medical complications associated with the disease.

“SMA is a grievous disease with a huge impact on the daily life of patients and their families, who are currently left only with supportive care. We are proud to see the development of this medicine evolving, with the ultimate goal of a potential first medicine for SMA,” said Christine Placet, Chief Executive Officer at Trophos. “This is a tremendous recognition of the work done by Trophos’ teams and supporters over the past 16 years.”

Under the agreement, Roche will pay Trophos’ shareholders roughly $139 million upfront and contingent payments of up to $406 million based on achievement of certain milestones.

“This acquisition highlights Roche’s commitment to developing medicines for spinal muscular atrophy, a serious disease with no effective treatment,” said Sandra Horning, MD, Chief Medical Officer and Head of Global Product Development at Roche. “We will build on the work done by Trophos and the French Muscular Dystrophy Association to advance the development of olesoxime and to bring it to people who live with this devastating condition as quickly as possible.”

The acquisition marks Roche’s fourth deal announced this week. In addition Roche’s deal with Trophos, the company acquired a majority stake in Foundation Medicine for $1.2 billion, and obtained rights from Meji Seika Pharma and Fedora Pharmaceuticals to develop an early-stage infection disease compound for up to $750 million.

Source: Roche