Roche has announced CE Mark approval for its cobas BV/CV (Bacterial Vaginosis/Candida Vaginitis) assay to identify specific bacteria and yeast responsible for bacterial vaginosis and candida vaginitis in vaginal samples from symptomatic patients. The test is now available in countries accepting the CE Mark.
The cobas BV/CV assay detects the leading infectious causes of bacterial vaginosis and candida vaginitis in a single test using a single vaginal swab. The test delivers results in less than three hours compared with days for traditional methods such as cultures.
“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,” said Matt Sause, CEO of Roche Diagnostics. “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.”
Clinicians typically rely on microscopy, pH testing, and clinical observation to diagnose bacterial vaginosis and candida vaginitis, which present with non-specific symptoms. These methods can deliver inaccurate results, leading to delays in treatment or prescription of unsuitable therapies.
Bacterial vaginosis impacts approximately 25% of women of reproductive age, while up to 75% of women experience candida vaginitis at least once in their lifetime, according to published studies. Vaginal symptoms are one of the most common reasons women visit the doctor each year. Bacterial vaginosis and candida vaginitis infections are associated with an increased risk of having a sexually transmitted infection.
The global sexual health market segment is valued at CHF 1.1 billion (approximately €1.2 billion), with an annual growth rate of 11%. Vaginitis is the primary growth driver with a yearly growth rate of 26%, according to IQVIA.
The cobas BV/CV assay expands Roche Diagnostics’ sexual health portfolio. The assay enables testing for bacterial vaginosis and candida vaginitis alongside sexually transmitted infections including Chlamydia, Gonorrhoea, Trichomonas, and Mycoplasma genitalium using the same sample. The assay runs on the cobas 5800/6800/8800 systems.
