Original from: Roche
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its cobas® BV/CV (Bacterial vaginosis/Candida vaginitis) assay. This molecular diagnostic test provides results for both Bacterial vaginosis (BV) and Candida vaginitis (CV) from a single vaginal swab sample. It enables accurate and timely results that can lead to improved patient outcomes and enhanced healthcare efficiencies.
Vaginitis is one of the most common reasons women visit a healthcare provider, with Bacterial vaginosis (BV) and Candida vaginitis (CV) being two of the most frequent causes of infection. Clinicians have traditionally relied on less precise methods such as microscopy, pH testing and clinical observation to diagnose these conditions, yet these methods lack precision. Accurate vaginitis diagnosis is a cornerstone of effective treatment, yet misdiagnosis of this condition is close to 50%, raising the risk of recurrence.
"Compared to traditional methods, the cobas® BV/CV test can help improve diagnostic accuracy for women affected by vaginitis, addressing a critical need in women's health," said Brad Moore, President and CEO, Roche Diagnostics North America. "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."
Bacterial vaginosis impacts approximately 27% of women of reproductive age in North America, while up to 75% of women experience Candida vaginitis at least once in their lifetime. Diagnosis of these conditions can be challenging as symptoms are often non-specific, and traditional testing methods, such as microscopy, lack precision. BV and CV infections can cause uncomfortable and sometimes distressing symptoms such as itching, burning, discharge and irritation, and are also associated with an increased risk of having a sexually transmitted infection (STI).
The cobas® BV/CV assay, an in vitro diagnostic test, is only available for professional laboratory use based on a clinician's order. The assay utilizes real-time polymerase chain reaction (PCR) technology to accurately identify the specific bacteria and yeast responsible for BV and CV in vaginal samples from symptomatic patients. The test detects DNA targets for organisms associated with BV, includingGardnerella vaginalis, Atopobium vaginae and Lactobacillus spp. It also detects Candida species associated with CV, including C. albicans, C. glabrata, C. krusei, C. parapsilosis, C. tropicalis and C. dubliniensis.
The test aligns with guidelines from the Centers for Disease Control and Prevention, which does not recommend speciation prior to first-line therapy. Additional Candida speciation or susceptibility testing should be performed if there is persistent or recurrent infection defined by three or more episodes of symptomatic CV within one year or documented treatment failure with first-line therapy.
The sample is collected using a clinician-collected or clinician-instructed, self-collected vaginal swab in cobas® PCR Media in a healthcare setting. This enables diagnosis from a single sample that can also be used for broader sexual-health testing with the cobas® CT/NG (Chlamydia trachomatis/Neisseria gonorrhoeae) and cobas® TV/MG (Trichomonas vaginalis/Mycoplasma genitalium) assays, eliminating the need for additional samples for extended testing.
Roche's Sexual-Health Portfolio
The cobas® BV/CV assay further expands Roche Diagnostics' established sexual-health portfolio to provide a full testing menu for sexually transmitted infections. By enabling concurrent testing for BV and CV alongside a broad range of STIs, including Chlamydia trachomatis, Neisseria gonorrhea, Trichomonas vaginalis and Mycoplasma genitalium, from the same sample, it enhances the capabilities of the cobas® 6800/8800 systems. This streamlined approach supports sexual-health clinics, hospitals and laboratories by delivering faster, more efficient workflows, while also ensuring that patients benefit from accurate diagnosis and timely care. Roche plans to add the cobas® 5800 system to the assay via the FDA's Reagent Replacement and Instrument Family Policy. The commercial launch is expected later this year.
Source: Roche receives FDA clearance for the cobas® BV/CV assay, enabling fast and highly accurate vaginitis diagnosis
