Roche Nabs CE Mark for PCR-Based Vaginitis Assay

Original from: genomeweb

Roche announced Tuesday that its PCR-based test for vaginitis has received CE marking. The test is now available in countries accepting the designation.

The Cobas Bacterial Vaginosis/Candida Vaginitis (BV/CV) assay is designed to help clinicians diagnose the infectious causes of vaginitis by detecting bacteria associated with bacterial vaginosis and yeast associated with candida vaginitis, Roche said in a statement. The test is intended for use with vaginal samples from symptomatic patients collected using the Cobas PCR Media proprietary tube, and it runs on the Cobas 5800/6800/8800 PCR systems. 

Diagnosis of these conditions can be difficult because symptoms are often nonspecific and traditional testing methods, such as microscopy, lack precision, Roche noted. BV and CV are also associated with an increased risk of having a sexually transmitted infection.

"The Cobas BV/CV assay protects women from the risks of delayed or incorrect treatment, leading to faster relief from symptoms and a reduced likelihood of serious future complications," Roche Diagnostics CEO Matt Sause said in a statement. "At the same time, it improves efficiency for healthcare services by accurately identifying the most common causes of inflammation or infection in a single test." 

Source: Roche Nabs CE Mark for PCR-Based Vaginitis Assay