Roche receives FDA clearance with CLIA waiver and CE Mark for its first point-of-care test for diagnosing Bordetella infections, including whooping cough (pertussis)

Rhea-AI Summary

Roche (OTCQX:RHHBY) announced U.S. FDA 510(k) clearance with a CLIA waiver and CE IVDR certification for its first point-of-care PCR test for Bordetella infections, including whooping cough, on 2 December 2025.

The cobas liat system delivers PCR-accurate results in 15 minutes at GP practices and emergency rooms, and detects and differentiates three Bordetella species (B. pertussis, B. parapertussis, B. holmesii) to support faster, targeted treatment and reduce severe complications and transmission.

Positive

• FDA 510(k) clearance and CLIA waiver secured (U.S.)
• CE IVDR certification obtained for EU market
• Test provides PCR-accurate results in 15 minutes at point-of-care
• Differentiates three Bordetella species for targeted diagnosis
• Designed for use in GP practices and ERs enabling immediate treatment decisions

Negative

• Pertussis shows 3–5 year cyclical peaks, causing variable demand
• Pandemic-related interruptions in routine vaccinations and waning immunity have created unpredictable case surges

News Market Reaction – RHHBY

+2.50%

+2.50% Session close to close

In the Dec 2 session, RHHBY gained 2.50%, reflecting a moderate positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement highlights an FDA-cleared, CLIA-waived point-of-care PCR test that delivers Bordet...

Analysis

This announcement highlights an FDA-cleared, CLIA-waived point-of-care PCR test that delivers Bordetella results in 15 minutes and differentiates three species, targeting a disease burden of 24.1 million cases and 170,000 deaths annually. It extends Roche’s diagnostics footprint after prior FDA and CE approvals in oncology and infectious disease. Investors may watch uptake of the cobas liat platform, further regulatory expansions, and how new assays contribute to overall diagnostics growth.

Key Figures

Time to result: 15 minutes Annual pertussis cases: 24.1 million cases Annual pertussis deaths: 170,000 deaths +2 more

5 metrics

Time to result 15 minutes Turnaround time for Bordetella point-of-care PCR test

Annual pertussis cases 24.1 million cases Estimated global whooping cough burden per year

Annual pertussis deaths 170,000 deaths Estimated global whooping cough mortality per year

Disease cycle length every three to five years Typical cyclical peak pattern of whooping cough

CLIA reference year 1988 Clinical Laboratory Improvement Amendments of 1988 cited in waiver

Historical Context

5 past events · Latest: Dec 10 (Positive)

Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Dec 10	Breast cancer data	Positive	+3.5%	Positive Phase III lidERA results reduced recurrence or death risk by 30%.
Dec 10	Breast cancer data	Positive	+3.5%	Roche detailed giredestrant Phase III data showing 30% risk reduction vs SoC.
Dec 09	CE Mark diagnostic	Positive	-0.4%	CE Mark for cobas BV/CV vaginitis PCR assay expanding sexual health testing.
Dec 09	EU drug approval	Positive	-0.4%	European Commission approved Gazyva/Gazyvaro for adults with lupus nephritis.
Dec 08	Oncology data	Positive	-0.4%	ASH 2025 Lunsumio data showed high CR rates and durable lymphoma responses.

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

Pattern Detected

Recent positive clinical and regulatory updates often led to mixed reactions, with sizeable gains on major oncology data but mild declines around some approvals and diagnostic launches.

Recent Company History

Over recent months, Roche has reported several notable developments. On Dec 8–10, 2025, it highlighted positive data for Lunsumio, an EU approval for Gazyva/Gazyvaro in lupus nephritis, and strong Phase III lidERA results for giredestrant, with the latter coinciding with a +3.55% move. Earlier in 2025, multiple FDA clearances and CE Marks for diagnostics and B‑cell lymphoma testing drew smaller or negative reactions. Today’s point-of-care Bordetella test clearance and CE IVDR certification extends this diagnostics expansion theme.

Key Terms

pcr, point-of-care test, fda 510(k) clearance, clia waiver, +4 more

8 terms

pcr medical

"The point-of-care test delivers PCR-accurate results in just 15 minutes"

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.

point-of-care test medical

"Roche announced today that its first point-of-care test for the diagnosis"

A point-of-care test is a medical diagnostic performed where a patient is seen—such as a clinic, pharmacy, or bedside—delivering quick results without sending samples to a distant lab. Investors care because these tests can speed treatment decisions, expand where services are offered, and create new revenue and cost-saving opportunities; think of them as instant checks that let care providers act immediately rather than waiting for lab results.

fda 510(k) clearance regulatory

"has been granted U.S. Food and Drug Administration (FDA) 510(k) clearance"

FDA 510(k) clearance is an official approval from the U.S. Food and Drug Administration that allows medical devices to be legally sold in the United States. It indicates the device is considered safe and effective based on its similarity to already approved products. For investors, achieving 510(k) clearance can signal a company's readiness to bring a medical device to market and generate revenue.

clia waiver regulatory

"FDA 510(k) clearance and Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver"

A CLIA waiver is an official permission that lets a medical test be performed outside specialized laboratories—such as in a doctor’s office, pharmacy, or clinic—because the test is simple, safe, and unlikely to give wrong results. For investors, a waiver often means a much larger, faster market rollout and lower costs for adoption, similar to a consumer product moving from specialty stores onto supermarket shelves.

ce mark regulatory

"in addition to CE IVDR certification. The groundbreaking PCR test"

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.

ivdr regulatory

"in addition to CE IVDR certification."

A medical-device regulation that sets safety, performance and market-entry rules for in vitro diagnostic tests — the lab tests and kits used to analyze blood, tissue or other samples outside the body. It matters to investors because it shapes which products can be sold, how long approvals take, and how much companies must spend to comply; like a new building code, tighter rules can raise costs and delay launches but also raise barriers for competitors.

emergency rooms medical

"deliver results in just 15 minutes in GP practices and Emergency Rooms."

Emergency rooms are the hospital departments open 24/7 that provide immediate care for serious or sudden illnesses and injuries, acting like a hospital’s front door or a medical fire station for urgent needs. For investors, ERs matter because they are a steady source of patient volume and revenue, can be costly to staff and equip, and their caseload and who pays the bills affect a health system’s profitability and cash flow.

antibiotics medical

"take immediate action to provide appropriate antibiotics that can prevent severe complications"

Antibiotics are medicines that kill or stop the growth of bacteria, acting like targeted tools that clear bacterial infections while leaving human cells largely unharmed. Investors care because antibiotics drive sales, influence hospital and outpatient treatment patterns, and face unique risks—such as regulatory approval hurdles, shrinking effectiveness from resistance, and stewardship policies—that can shorten a drug’s commercial life and affect company revenue and valuation.

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

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• The point-of-care test delivers PCR-accurate results in just 15 minutes, enabling healthcare providers to act quickly and prevent severe complications and onward transmission.
• Detects and differentiates between three types of Bordetella infection that can cause similar cough symptoms, ensuring patients receive the right diagnosis at the earliest opportunity.
• Early diagnosis can reduce the risk of complications and severe disease in vulnerable groups such as infants and the elderly, by enabling faster, more precise care decisions.

Basel, 2 December 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that its first point-of-care test for the diagnosis of whooping cough (pertussis) and other Bordetella infections, has been granted U.S. Food and Drug Administration (FDA) 510(k) clearance and Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver, in addition to CE IVDR certification. The groundbreaking PCR test uses the cobas® liat system to deliver results in just 15 minutes in GP practices and Emergency Rooms. This speed enables physicians to diagnose patients during their consultation and take immediate action to provide appropriate antibiotics that can prevent severe complications and onward transmission.

Pertussis affects people of all ages but can be more severe in children, causing an estimated 24.1 million cases and 170,000 deaths annually.¹  A major diagnostic challenge is that early symptoms are often indistinguishable from other respiratory illnesses. This lack of rapid, accessible diagnostics causes clinicians to treat based on symptoms, a delay that allows the disease to progress and leads to severe outcomes, especially for vulnerable groups.

"Faster and more accurate clinical decisions are critical for reducing the risk of severe complications and ultimately stopping the transmission of Bordetella infections.” said Matt Sause, CEO of Roche Diagnostics. “This new test allows clinicians to quickly make a definitive and precise diagnosis to ensure patients get the right treatment earlier."

The test not only detects Bordetella infections but also differentiates between three key species: B. pertussis, the cause of classic whooping cough; B. parapertussis, which causes a milder pertussis-like illness that may not respond to standard treatments; and B. holmesii, an emerging pathogen increasingly associated with pertussis-like symptoms and potential diagnostic challenges.

Whooping cough is a cyclical disease that typically peaks in severity every three to five years.² With a surge underway³, the increase in cases has been further amplified by interruptions in routine vaccinations during the pandemic, along with waning immunity and vaccine hesitancy. These factors have driven infections across all age groups, including older children and adults, where symptoms can be less typical and harder to recognise.

Bordetella infections, including whooping cough, are a significant challenge for clinicians due to the similarity of early symptoms to other respiratory infections. Accurately identifying Bordetella among these conditions is essential to delivering the right treatment and ensuring timely intervention.

About the cobas® liat system
The test is delivered using the cobas® liat system, already used by healthcare professionals worldwide for point-of-care diagnostics. The compact system delivers PCR-accurate definitive results in 20 minutes or less to aid in patient care decisions. This new assay expands the cobas® liat system’s capabilities, complementing existing respiratory assays for the detection of SARS-CoV-2, Influenza A, Influenza B, Respiratory Syncytial Virus (RSV), and Group A Streptococcus (Strep A).  By enabling clinicians to test for a range of conditions during the patient consultation, the system empowers faster, more decisive care decisions and reduces reliance on central laboratory facilities.

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.

For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045. 

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] Yeung KHT, Duclos P, Nelson EAS, Hutubessy RCW. An update of the global burden of pertussis in children younger than 5 years: a modelling study. Lancet Infect Dis. 2017;17(9):974-980. doi:10.1016/S1473-3099(17)30390-0.
[2] CDC. https://www.cdc.gov/pertussis/outbreaks/index.html
[3] PAHO.https://www.paho.org/en/news/26-8-2025-paho-calls-strengthened-vaccination-and-surveillance-amid-spread-antibiotic

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

Hans Trees, PhD Phone: +41 79 407 72 58	Sileia Urech Phone: +41 79 935 81 48
Nathalie Altermatt Phone: +41 79 771 05 25	Lorena Corfas Phone: +41 79 568 24 95
Simon Goldsborough Phone: +44 797 32 72 915	Karsten Kleine Phone: +41 79 461 86 83
Kirti Pandey Phone: +49 172 6367262	Yvette Petillon Phone: +41 79 961 92 50
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 bordetella test English

FAQ

What regulatory clearances did Roche receive for its Bordetella point-of-care test (RHHBY) on December 2, 2025?

Roche received FDA 510(k) clearance with a CLIA waiver in the U.S. and CE IVDR certification in Europe.

How fast does the Roche cobas liat Bordetella test (RHHBY) deliver results in GP and ER settings?

The test delivers PCR-accurate results in 15 minutes at point-of-care locations.

Which Bordetella species does Roche's point-of-care test (RHHBY) detect and differentiate?

The test detects and differentiates B. pertussis, B. parapertussis, and B. holmesii.

What clinical benefit does the 15-minute Roche test (RHHBY) provide to clinicians?

It enables clinicians to diagnose during consultation and take immediate action, supporting timely antibiotic treatment to reduce complications and transmission.

Will the Roche Bordetella point-of-care test (RHHBY) be suitable for primary care and emergency departments?

Yes. The cobas liat system is intended for use in GP practices and emergency rooms to support rapid decisions during patient visits.

How does the current perturbation in vaccination coverage affect Bordetella cases relevant to Roche (RHHBY)?

The release notes that pandemic interruptions to routine vaccinations, waning immunity, and vaccine hesitancy have contributed to a surge in cases, increasing clinical demand and diagnostic needs.