Roche receives FDA clearance for the cobas® BV/CV assay, enabling fast and highly accurate vaginitis diagnosis
Rhea-AI Summary
Roche (OTCQX:RHHBY) announced that the U.S. FDA has granted 510(k) clearance for the cobas® BV/CV assay, a real-time PCR test that detects organisms associated with bacterial vaginosis and Candida vaginitis from a single clinician-collected or clinician-instructed, self-collected vaginal swab.
The in vitro diagnostic assay, for professional laboratory use on the cobas® 6800/8800 systems, provides simultaneous BV and CV results for symptomatic women and can be combined with cobas® CT/NG and cobas® TV/MG assays for broader sexual-health testing from the same sample. According to Roche, this supports faster, more accurate diagnosis, streamlined workflows for laboratories and clinics, and integration with CDC guidelines on Candida speciation. Roche plans to extend the assay to the cobas® 5800 system under the FDA’s Reagent Replacement and Instrument Family Policy, with U.S. commercial launch expected later in 2026.
Positive
- FDA 510(k) clearance for cobas® BV/CV assay in the U.S.
- Single vaginal swab yields concurrent BV and CV results for symptomatic women
- Assay runs on cobas® 6800/8800 with planned addition of cobas® 5800
- Shared sample supports combined testing with CT/NG and TV/MG assays
- Expansion of Roche’s sexual-health diagnostics portfolio from one specimen
Negative
- None.
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- The new PCR test uses clinician-collected or clinician-instructed, self-collected vaginal swab specimens to simultaneously detect organisms associated with Bacterial vaginosis (BV) and Candida vaginitis (CV).
- This molecular assay can help improve diagnostic accuracy for symptomatic women affected by vaginitis, compared to traditional methods.¹
- The assay expands the sexual-health testing menu on the cobas® 6800/8800 systems, enabling a broad-range of testing from a single sample.
Vaginitis is one of the most common reasons women visit a healthcare provider,2 with Bacterial vaginosis (BV) and Candida vaginitis (CV) being two of the most frequent causes of infection.3 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.4,5,6 Accurate vaginitis diagnosis is a cornerstone of effective treatment, yet misdiagnosis of this condition is close to
"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
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, including Gardnerella 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.
About Roche
Roche is a healthcare company uniquely placed to prevent, stop and cure diseases by uniting leading science and technology across diagnostics, medicines and digital solutions.
Roche was founded in Basel, Switzerland in 1896 and today is a leading provider of transformative medicines and diagnostics for millions of people in over 150 countries around the world. It is dedicated to tackling healthcare challenges that place the greatest strain on patients, families, communities and healthcare systems. Across its Diagnostics and Pharmaceutical divisions, Roche focuses on areas including oncology, neurology, cardiovascular and metabolic diseases, ophthalmology, infectious diseases and immunology with the aim of providing real and positive change for patients, the people they love and the professionals who care for them.
Genentech in the United States is a fully owned subsidiary in the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, a major innovator in the Japanese therapeutic antibody market.
For more information, please visit www.roche.com.
All trademarks used or mentioned in this release are protected by law.
For Further Information
Roche Diagnostics U.S. Media Relations
us.mediarelations@roche.com
Krystina Monaco
1-317-850-7521
krystina.monaco@roche.com
Lori McLaughlin
1-463-207-2395
lori.mclaughlin@roche.com
References
- Melo A., et al. Concordance Between Clinical and Laboratory Diagnosis of Abnormal Vaginal Discharge in Chilean Women. Rev Bras Ginecol Obstet. Aug 2021;43(8): 600-607. doi: 10.1055/s-0041-1735299. Epub September 21, 2021. PMID: 34547794; PMCID: PMC10183927.
- ACOG Committee on Practice Bulletins—Gynecology. ACOG Practice Bulletin. Clinical management guidelines for obstetrician-gynecologists, Number 72, May 2006: Vaginitis. Obstet Gynecol. May 2006;107(5): 1195-1206. doi: 10.1097/00006250-200605000-00049. PMID: 16648432.
- Paladine HL. Vaginitis: Diagnosis and Treatment. Am Fam Physician. March 1, 2018;97(5): 321-329. PMID: 29671516.
- Anderson MR, et al. Evaluation of vaginal complaints. JAMA. Mar 17, 2004; 291(11):1368-79. doi: 10.1001/jama.291.11.1368. PMID: 15026404.
- Lynch T, et al. . Molecular Diagnosis of Vaginitis: Comparing Quantitative PCR and Microbiome Profiling Approaches to Current Microscopy Scoring. J Clin Microbiol. August 26, 2019; 57(9):e00300-19. doi: 10.1128/JCM.00300-19. PMID: 31315951; PMCID: PMC6711928.
- Melo, et al. Concordance between clinical and laboratory diagnosis of abnormal vaginal discharge in Chilean women. Rev Bras Ginecol Obstet. August 2021; 43(8): 600-607.
- Brown H, Drexler M. Improving the Diagnosis of Vulvovaginitis: Perspectives to Align Practice, Guidelines, and Awareness. Population Health Management. 2020; 23(1_suppl): S-3-S-12. doi:10.1089/pop.2020.0265.
- Peebles K, Velloza J, Balkus JE, McClelland RS, Barnabas RV. High global burden and costs of bacterial vaginosis: A systematic review and meta-analysis. Sex Transm Dis. May 2019; 46(5): 304-311. doi: 10.1097/OLQ.0000000000000972. PMID: 30624309.
- Centers for Disease Control and Prevention. Sexually transmitted infections guidelines, 2021.
- Schwebke JR, Nyirjesy P, Dsouza M, Getman D. Vaginitis and risk of sexually transmitted infections: results of a multi-center U.S. clinical study using STI nucleic acid amplification testing. J Clin Microbiol. August 14, 2024; 62(9): e00816-24.
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SOURCE Roche