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.
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The polymerase chain reaction (PCR) test enables wider sexual health testing using one vaginal swab, without requiring additional sampling.
Roche noted that current diagnostic practices for BV and CV, such as microscopy, potential of hydrogen (pH) testing, and clinical observation, are often hampered by non-specific symptoms and can produce unreliable results.
This can result in delays to treatment or the use of inappropriate therapies.
The BV/CV assay aims to address these challenges by providing precise results, allowing healthcare professionals to prescribe targeted therapies quickly.
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By GlobalDataInfections such as BV and CV can cause symptoms including burning, itching, irritation, and discharge, and are also linked to a higher risk of contracting sexually transmitted infections (STIs).
The cobas BV/CV assay expands the company’s sexual health portfolio by enabling BV and CV testing alongside a range of STIs, such as gonorrhoea, chlamydia, trichomonas, and mycoplasma genitalium, utilising the same sample.
This capability enhances the utility of the cobas 5800, 6800, and 8800 systems, supporting clinics, labs, and hospitals with quick workflows and prompt patient care.
The assay is currently available in nations that recognise the CE Mark.
Roche Diagnostics CEO Matt Sause said: “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.
“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.”
Roche recently received 510(k) clearance from the US Food and Drug Administration and CE In Vitro Diagnostic Medical Devices Regulation certification for its point-of-care PCR test for pertussis (whooping cough) and other Bordetella infections.
