SOUTH SAN FRANCISCO (dpa-AFX) - Friday, Roche Holding AG (RHHBY.PK) announced that the U.S. Food and Drug Administration has granted 510(k) clearance to its cobas Bacterial vaginosis/Candida vaginitis or BV/CV assay for the diagnosis of vaginitis.
The molecular diagnostic test provides results for both Bacterial vaginosis and Candida vaginitis from a single vaginal swab sample unlike traditional methods, such as microscopy, pH testing and clinical observation, providing accurate and timely results.
The test, which utilizes real-time polymerase chain reaction technology, is available only for professional laboratory use based on a clinician's order.
'By expanding our sexual-health portfolio to include comprehensive results for the most common conditions from a single sample, we can streamline care to help patients receive the right treatment faster,' said Brad Moore, President and CEO, Roche Diagnostics North America.
Roche's stock closed yesterday's trading at $53.92, up 4.29 percent on the OTC Markets.
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