NEW YORK – The US Food and Drug Administration on Thursday authorized a new test from Roche for the detection of methicillin-resistant Staphylococcus aureus bacterial colonization.
The authorization, which was granted through FDA's de novo premarket review pathway, allows Roche to market the Cobas vivoDx MRSA test with the Cobas vivoDx System. The in vitro diagnostic test is for the direct detection of live MRSA cells in nasal swab sample from patients who are at risk for nasal colonization by MRSA, according to Roche's website. Leveraging "selective agents" and Smarticles technology, the Cobas vivoDx MRSA test creates an amplified luminescent signal in viable MRSA cells.
Smarticles bioparticles are custom-designed DNA packaged into DNA-delivery bioparticles that bind to specific receptors on target bacteria's surface, according to Roche.
In a statement, the FDA noted that the test detects MRSA in nasal swabs in as little as five hours, compared to 24 to 48 hours in conventional culture. The agency added that in issuing the marketing authorization, it reviewed data from studies that showed the test correctly identified MRSA in about 90 percent of samples in which MRSA was present and correctly identified no MRSA in 98.6 percent of samples that did not have MRSA. Â