Roche's cobas MRSA / SA Test secures FDA 510(k) clearance - Verdict Medical Devices
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Roche’s cobas MRSA / SA Test secures FDA 510(k) clearance

27 Jan 2015 (Last Updated January 27th, 2015 18:30)

Roche has received 510(k) clearance from US Food and Drug Administration (FDA) for its cobas MRSA / SA Test for early and simultaneous detection of methicillin-resistant Staphylococcus aureus (MRSA) and methicillin-sensitive Staphylococcus aureus (SA) directly from nasal specimens.

Roche has received 510(k) clearance from US Food and Drug Administration (FDA) for its cobas MRSA / SA Test for early and simultaneous detection of methicillin-resistant Staphylococcus aureus (MRSA) and methicillin-sensitive Staphylococcus aureus (SA) directly from nasal specimens.

The company claims the test can detect both organisms from a single specimen, offering accurate results to control MRSA / SA infections.

NorthShore University HealthSystem director of Microbiology and Infectious Diseases Research Lance Peterson said: "Numerous successful surveillance programmes have led to a significant decrease in the rate of MRSA clinical infection in many organisations, and a dramatic reduction in post-operative 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.

"The cobas MRSA / SA Test demonstrated excellent performance in detecting both MRSA and SA strains in samples collected throughout the US.

"The cobas MRSA / SA Test is a polymerase chain reaction (PCR) based assay, which runs on the automated cobas 4800 System."

"Compared to culture testing, the cobas MRSA / SA Test offers confidence in identifying colonised patients the first time they are evaluated, aiding in the prevention of MRSA disease and post-operative SA surgical infections."

The cobas MRSA / SA Test is a polymerase chain reaction (PCR) based assay, which runs on the automated cobas 4800 System.

It offers simplified workflow available, with a simple de-cap and loading of the primary sample vial on the cobas 4800 System.

Roche Molecular Diagnostics head Paul Brown said: "Healthcare-associated infections continue to be a leading cause of mortality in US medical settings.

"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 4800 System is said to provide walkaway automation of nucleic acid purification, PCR setup and real-time PCR amplification and detection, which will allow laboratories to achieve maximum efficiency.

The expanding system menu currently available in the US includes cobas CT / NG Test (chlamydia / gonorrhoea), cobas HPV Test, cobas BRAF V600 Mutation Test and cobas EGFR Mutation Test.