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

• 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

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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.