Roche gains CE Mark for bacterial vaginosis/candida vaginitis assay

The assay is currently available in nations that recognise the CE Mark.

Roche has secured CE Mark approval for its cobas bacterial vaginosis/candida vaginitis (BV/CV) assay to support the diagnosis of infectious causes of vaginitis by identifying bacteria linked to BV and yeast associated with CV.

The assay works with vaginal samples gathered from symptomatic patients with the company’s cobas PCR Media tube.

The polymerase chain reaction (PCR) test enables wider sexual health testing using one vaginal swab, without requiring additional sampling.

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