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| Roche's cobas 4800 system--Courtesy of Roche |
Roche ($RHHBY) got an FDA OK for its rapid test for Clostridium difficile, picking up another regulatory gold star as it broadens its offerings on its cobas 4800 system.
The company's cobas Cdiff test screens for a C. difficile gene in stool samples, helping physicians make treatment decisions while potentially preventing infections in healthcare settings, Roche said in a statement. Regulators based their approval on a U.S. clinical trial which found that the company's product showed high sensitivity, quick turnaround times and fewer preanalytic steps compared to standard testing methods. The test runs on Roche's cobas 4800 PCR system, which includes tests for methicillin-resistant Staphylococcus aureus (MRSA), herpes and chlamydia.
"With the addition of the cobas Cdiff Test to the cobas 4800 system menu, Roche is able to expand the tools available to assist clinicians in the management of healthcare associated infections," Paul Brown, head of Roche Molecular Diagnostics, said in a statement. "The cobas Cdiff Test requires less sample handling and provides laboratories with a simplified workflow, when compared to other molecular methods. It also delivers a lower inhibition rate, which means fewer repeat samples and chances for error, enabling better patient care."
The regulatory blessing follows a string of recent approvals for Roche. In January, the diagnostics giant got an FDA green light for its drug-resistant MRSA/SA test, building out its menu of tests on its cobas 4800 system while striving to prevent healthcare-associated infections. Earlier this month, Roche scored FDA approval for its KRAS mutation test for metastatic colorectal cancer as it continues to expand its diagnostic offerings.
Roche also faces some competition in the C. difficile arena as other companies roll out rival products. Last year, diagnostics heavyweight Qiagen ($QGEN) scored FDA 510(k) clearance for its C. difficile assay and new molecular diagnostic system. In January, Middleton, WI-based Lucigen raised $2 million to support development of its tests for C. difficile and Ebola. Gaithersburg, MD-based OpGen ($OPGN) is also hard at work on its real-time PCR-based testing services for the bacterial infection.
- read the release
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