The new PCR-based test processes clinician-collected or clinician-guided self-collected vaginal swab samples to detect organisms linked with Bacterial vaginosis (BV) and Candida vaginitis (CV) at the same time.
This molecular test boosts diagnostic precision for women experiencing vaginitis symptoms when compared with conventional approaches.¹
The assay broadens the sexual-health testing options on the cobas 6800/8800 systems, supporting extensive testing from one sample.

/PRNewswire/ -- 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 delivers results for both Bacterial vaginosis (BV) and Candida vaginitis (CV) from a single vaginal swab sample. It supports accurate and prompt outcomes that can improve patient results and streamline healthcare processes.

Vaginitis ranks among the top reasons women seek care from healthcare providers,² with Bacterial vaginosis (BV) and Candida vaginitis (CV) among the leading causes of infection.³ Clinicians have long used less exact techniques such as microscopy, pH testing and clinical observation to identify these issues, yet these approaches fall short in precision.⁴,⁵,⁶ Proper vaginitis diagnosis forms the basis of successful treatment, but misdiagnosis occurs in nearly half of cases, increasing the chance of recurrence.⁷

"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 affects about 27 percent of women of reproductive age in North America,⁸ while up to 75 percent of women encounter Candida vaginitis at least once during their lifetime.⁹ Diagnosis proves difficult because symptoms often overlap and standard testing like microscopy lacks accuracy. BV and CV can lead to uncomfortable symptoms including itching, burning, discharge and irritation, and they raise the risk of sexually transmitted infections (STIs).¹⁰

The cobas BV/CV assay, an in vitro diagnostic test, is intended solely for professional laboratory use following a clinician's order. The assay applies real-time polymerase chain reaction (PCR) technology to identify the exact bacteria and yeast causing BV and CV in vaginal samples from symptomatic patients. The test targets DNA from organisms tied to BV, such as Gardnerella vaginalis, Atopobium vaginae and Lactobacillus spp. It also identifies Candida species linked to CV, including C. albicans, C. glabrata, C. krusei, C. parapsilosis, C. tropicalis and C. dubliniensis.

The test follows guidelines from the Centers for Disease Control and Prevention, which advise against speciation before initial therapy. Further Candida speciation or susceptibility testing is recommended only for persistent or recurrent infection, defined as three or more symptomatic CV episodes in one year or confirmed failure of first-line treatment.

The sample is obtained via clinician-collected or clinician-instructed self-collected vaginal swab placed in cobas PCR Media within a healthcare setting. This allows diagnosis from one sample that can also support broader sexual-health testing with the cobas CT/NG (Chlamydia trachomatis/Neisseria gonorrhoeae) and cobas TV/MG (Trichomonas vaginalis/Mycoplasma genitalium) assays, removing the need for extra samples during extended testing.

Roche's Sexual-Health Portfolio

The cobas BV/CV assay further expands Roche Diagnostics' established sexual-health portfolio to deliver a complete testing menu for sexually transmitted infections. By enabling concurrent testing for BV and CV alongside a wide range of STIs, including Chlamydia trachomatis, Neisseria gonorrhea, Trichomonas vaginalis and Mycoplasma genitalium, from the same sample, it strengthens the capabilities of the cobas 6800/8800 systems. This efficient method aids sexual-health clinics, hospitals and laboratories with quicker workflows while ensuring patients receive accurate diagnosis and timely care. Roche plans to extend the assay to the cobas 5800 system through 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 positioned 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
[email protected]

Krystina Monaco
1-317-850-7521
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Lori McLaughlin
1-463-207-2395
[email protected]

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.

SOURCE Roche