Roche launches new PCR test to help improve diagnostic accuracy for women affected by vaginitis in countries following the CE Mark

Roche (OTCQX: RHHBY) received the CE Mark for its cobas® BV/CV PCR assay on 9 December 2025 to detect bacteria causing bacterial vaginosis and yeast causing candida vaginitis from a single vaginal swab.

Rhea-AI Summary

Roche (OTCQX: RHHBY) received the CE Mark for its cobas® BV/CV PCR assay on 9 December 2025 to detect bacteria causing bacterial vaginosis and yeast causing candida vaginitis from a single vaginal swab.

The test enables broader sexual health testing on cobas 5800/6800/8800 systems without an additional sample, aims to improve diagnostic accuracy versus microscopy/pH/clinical observation, and is now available in countries accepting the CE Mark.

Market context: the global sexual health segment is valued at CHF 1.1 bn with 11% annual growth; vaginitis growth is cited at 26% yearly.

Positive

• CE Mark received on 9 December 2025
• Single vaginal swab enables broader sexual health testing
• Integrates with cobas 5800/6800/8800 systems
• CHF 1.1 bn sexual health segment; vaginitis growth 26%

Negative

• None.

Argus Dec 9 session

-0.41% close to close Open Argus

Details

News Market Reaction – RHHBY

On Dec 9, the day this news came out, RHHBY closed 0.41% below the previous close.

Data tracked by StockTitan Argus for the Dec 9 session.

Market Context

This announcement highlighted Roche’s CE Marked cobas BV/CV PCR assay, which targets infectious caus...

Analysis

This announcement highlighted Roche’s CE Marked cobas BV/CV PCR assay, which targets infectious causes of vaginitis and taps into a sexual health market valued at CHF 1.1 bn with 11% annual growth and a vaginitis segment growing 26% yearly. It fits alongside recent positive clinical and regulatory updates in oncology and autoimmune disease. Investors may watch future adoption of the assay on cobas systems, additional regulatory milestones, and how vaginal infection testing contributes to Roche Diagnostics’ broader growth profile.

Key Figures

Sexual health market size: CHF 1.1 bn Market growth rate: 11% Vaginitis growth rate: 26% +5 more

Sexual health market size

CHF 1.1 bn

Global sexual health market segment referenced in assay launch

Market growth rate

11%

Annual growth rate of global sexual health segment

Vaginitis growth rate

26%

Yearly growth rate of vaginitis segment within sexual health

Bacterial vaginosis prevalence

25%

Women of reproductive age impacted by bacterial vaginosis

Candida vaginitis incidence

75%

Women experiencing candida vaginitis at least once in lifetime

Median follow-up

35.1 months

Phase III STARGLO three-year follow-up duration

Overall survival benefit

25.5 vs 12.5 months

OS Columvi+GemOx vs R-GemOx in STARGLO study

Progression-free survival

20.4 vs 5.5 months

PFS Columvi+GemOx vs R-GemOx in STARGLO study

Historical Context

5 past events · Latest: Dec 09

5 events

1. Dec 09

   Diagnostic launch

   24h Move

   -0.4%

   CE Mark and launch of cobas BV/CV vaginitis PCR assay.

2. Dec 09

   Drug approval EU

   24h Move

   -0.4%

   European Commission approval of Gazyva/Gazyvaro for lupus nephritis.

3. Dec 08

   Clinical data Lunsumio

   24h Move

   -0.4%

   Lunsumio combinations showing strong responses and survival data in lymphomas.

4. Dec 08

   Clinical data Lunsumio

   24h Move

   -0.4%

   Genentech Lunsumio data in earlier lymphoma treatment lines at ASH 2025.

5. Dec 08

   Phase III update

   24h Move

   +0.8%

   Three-year STARGLO data showing longer OS and PFS with Columvi combo.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

pcr, ce mark, bacterial vaginosis, candida vaginitis, +1 more

5 terms

pcr medical

"Roche launches new PCR test to help improve diagnostic accuracy..."

PCR (polymerase chain reaction) is a laboratory method that makes many copies of a tiny piece of genetic material (DNA or RNA) so scientists can detect and study it reliably — think of photocopying a faint, tiny note until the words are easy to read. For investors, PCR matters because it underpins diagnostic tests, drug development, and biotech tools whose sales, regulatory approvals, and real-world use can materially affect company revenues and market perceptions during health events or product launches.

ce mark regulatory

"Roche ... announced today the CE Mark for its cobas BV/CV..."

A CE mark is a regulatory stamp placed on products to show they meet the European Union’s basic safety, health and environmental rules and can be sold in the European Economic Area. For investors it matters because the mark unlocks market access, affects how quickly a product can generate revenue, and signals regulatory risk and potential compliance costs—think of it as a passport that lets a product enter a large market.

bacterial vaginosis medical

"detection of bacteria associated with bacterial vaginosis and yeast..."

An imbalance of the natural bacterial community in the vagina that can cause abnormal discharge, odor, and discomfort; it is not always an infection in the usual sense but a shift in which species dominate, similar to weeds overtaking a garden. Investors care because it is a common, recurring condition that drives demand for diagnostics, treatments and clinical trials, can affect regulatory reviews and labeling, and influences revenue and risk for companies developing products targeting women's reproductive health.

candida vaginitis medical

"bacteria associated with bacterial vaginosis and yeast associated with candida vaginitis."

Candida vaginitis is a common vaginal infection caused by an overgrowth of Candida yeast, producing itching, discharge, and irritation. For investors, it matters because its frequency and treatment options drive demand for prescription drugs, over‑the‑counter remedies, diagnostics and related health services; think of it like a recurring maintenance issue that determines how much customers and health systems will spend on products and innovation in women's health.

sexually transmitted infection medical

"BV and CV infections are also associated with an increased risk of having a sexually transmitted infection..."

A sexually transmitted infection is an infection passed between people through sexual contact, caused by bacteria, viruses, or parasites; think of it like catching an illness from close personal contact. Investors care because rates of these infections drive demand for testing, treatments, vaccines and public-health programs, influence regulatory approvals and reimbursement, and can affect costs for insurers and employers—so changes can meaningfully alter revenue and risk for healthcare-related companies.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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• The new PCR test aids in the diagnosis of infectious causes of vaginitis through the detection of bacteria associated with bacterial vaginosis and yeast associated with candida vaginitis. 
  
  
• The test will help improve diagnostic accuracy for millions of women¹ affected by vaginitis annually, delivering more accurate and specific results.
• This test offers faster diagnosis by using a single vaginal swab for broader sexual health testing, eliminating the need for an additional sample.

Basel, 9 December 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the CE Mark for its cobas® BV/CV (Bacterial Vaginosis/Candida Vaginitis) assay to accurately identify specific bacteria and yeast responsible for BV and CV in vaginal samples from symptomatic patients collected using the cobas PCR Media proprietary tube.

Clinicians typically rely on microscopy, pH testing, and clinical observation to diagnose BV and CV, which present with non-specific symptoms. These methods can deliver inaccurate results, leading to delays in treatment or prescription of unsuitable therapies. The cobas BV/CV assay resolves this challenge by delivering accurate and specific results, allowing healthcare professionals to deliver targeted therapies to patients more quickly.

“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.”

Bacterial vaginosis impacts approximately 25% of women of reproductive age², while up to 75% of women experience candida vaginitis at least once in their lifetime³. Vaginal symptoms are one of the most common reasons women visit the doctor each year. Diagnosis of these conditions can be challenging as symptoms are often non-specific, and traditional testing methods, such as microscopy, lack precision. Causing uncomfortable and sometimes distressing symptoms such as itching, burning, discharge, and irritation,  BV and CV infections are also associated with an increased risk of having a sexually transmitted infection (STI).⁴

The global sexual health market segment is valued at CHF 1.1 bn, with an annual growth rate of 11%. Of this market segment, vaginitis is the primary growth driver with a yearly growth rate of 26%.⁵ The cobas BV/CV assay further expands Roche Diagnostics’ established sexual health portfolio. By enabling testing for BV and CV alongside a broad range of sexually transmitted infections, including Chlamydia, Gonorrhoea, Trichomonas, and Mycoplasma genitalium, using the same sample, the assay enhances the capabilities of the cobas 5800/6800/8800 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.

The cobas BV/CV assay is now available in countries accepting the CE Mark.

About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.

In recognising our endeavour to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for the fifteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work.

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

References
[1] Hildebrand JP, Carlson K, Kansagor AT. Vaginitis. National Library of Medicine. 2025 Jan 19, PMID: 29262024  Bookshelf ID: NBK470302
[2] 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. 2019 May;46(5):304-311. doi: 10.1097/OLQ.0000000000000972. PMID: 30624309
[3] https://www.cdc.gov/std/treatment-guidelines/candidiasis.htm
[4] 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. 2024 Aug 14;62(9):e00816-24
[5]  FY24 IQVIA Diagnostics market book
 

Roche Global Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

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Dr Rebekka Schnell Phone: +41 79 205 27 03

Roche Investor Relations

Dr Bruno Eschli Phone: +41 61 68-75284 e-mail: bruno.eschli@roche.com	Dr Sabine Borngräber Phone: +41 61 68-88027 e-mail: sabine.borngraeber@roche.com
Dr Birgit Masjost Phone: +41 61 68-84814 e-mail: birgit.masjost@roche.com

Investor Relations North America

Loren Kalm Phone: +1 650 225 3217 e-mail: kalm.loren@gene.com

Attachment

• Media Investor Release BV_CV test English

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Roche (RHHBY) announce on 9 December 2025 about a new PCR test?

Roche announced CE Mark clearance for the cobas® BV/CV PCR assay to detect bacterial vaginosis and candida vaginitis from a single vaginal swab.

How does the cobas BV/CV assay change sample requirements for vaginitis testing (RHHBY)?

The assay uses a single vaginal swab in cobas PCR Media, eliminating the need for an additional sample for broader sexual health testing.

Which laboratory platforms support Roche's cobas BV/CV test (RHHBY)?

The cobas BV/CV assay is compatible with cobas 5800, 6800, and 8800 systems.

What market size and growth did Roche cite for sexual health and vaginitis (RHHBY)?

Roche cited a CHF 1.1 bn sexual health segment with 11% annual growth and stated vaginitis is a primary driver at 26% yearly growth.

How does Roche say the cobas BV/CV assay improves clinical diagnosis of vaginitis (RHHBY)?

Roche says the assay delivers more accurate and specific results than microscopy/pH/clinical observation, enabling faster targeted therapies.