Roche Holding's Vaginitis Diagnostic Test Secures FDA 510(k) Clearance

(RTTNews) - 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.