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Roche nabs FDA OK for drug-resistant bacteria test

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Roche's cobas 4800 system--Courtesy of Roche

Roche ($RHHBY) got an FDA green light for its drug-resistant MRSA/SA test, chalking up another regulatory win and expanding the company's offerings on its cobas 4800 system.

The Swiss diagnostics giant's product screens for methicillin-resistant Staphylococcus aureus and methicillin-sensitive S. aureus in nasal specimens, sussing out infectious bacteria from a single sample using the company's proprietary PCR system. Up to 85% of invasive MRSA infections are healthcare-associated, resulting in over 90,000 infections and 18,000 deaths in 2005, Roche said in a statement. The company's test could help screen for infection earlier, potentially cutting costs and preventing complications.

"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," Paul Brown, head of Roche Molecular Diagnostics, said in a statement.

Regulatory clearance for its next-generation MRSA/SA test comes on the heels of more good tidings for the company, as earlier this month Roche won FDA approval for its triple test to simultaneously detect HIV, hepatitis C and hepatitis B in donated blood and blood products. The company's TaqScreen MPX tool offers increased sensitivity and is expected to reduce sample volume and testing turnaround times.

And Roche is not the only company setting its sights on diagnostics for drug-resistant infections. Last year, Dutch diagnostics behemoth Qiagen ($QGEN) won European clearance for three of its tests for bacterial infections, including its artus diagnostic for MRSA. In April, molecular diagnostics outfit AdvanDx snagged $12 million in funding in a round led by Merck ($MRK) to develop its rapid tests for hospital-acquired infections including its mecA XpressFISH diagnostic for MRSA. The company bills the test as quicker than conventional screening methods, as it identifies antimicrobial resistant pathogens one to three days earlier than traditional tests.

- read the release

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