SHERIDAN, WYOMING - December 2, 2025 - Roche has secured FDA 510(k) clearance with a CLIA waiver and CE IVDR certification for its first point-of-care test to diagnose Bordetella infections, providing primary care and emergency clinicians with PCR-accurate results in just 15 minutes to help control whooping cough and related diseases.
Fast, PCR-accurate diagnosis at the point of care
Running on the cobas® liat system, Roche's new assay delivers lab-quality PCR results in GP offices and emergency rooms within a standard consultation. The 15-minute turnaround allows physicians to move from suspicion to definitive diagnosis immediately, supporting timely antibiotic prescribing that can prevent severe complications and reduce onward transmission.
Pertussis remains a major global burden, with an estimated 24.1 million cases and 170,000 deaths annually, and early symptoms often mirror other respiratory illnesses. In the absence of rapid, accessible diagnostics, clinicians have traditionally treated empirically based on symptoms, increasing the risk that vulnerable patients-especially infants and older adults-progress to severe disease before the causative pathogen is confirmed.
Differentiating three Bordetella species with similar presentations
A key feature of the new test is its ability not only to detect Bordetella infections but to differentiate three clinically relevant species that can present with similar cough symptoms. The assay identifies:
- Bordetella pertussis, the classic whooping cough pathogen
- Bordetella parapertussis, which causes a milder pertussis-like illness that may not respond to standard treatments
- Bordetella holmesii, an emerging organism increasingly linked to pertussis-like presentations and diagnostic ambiguity
By distinguishing among these organisms in near real time, the test helps clinicians tailor treatment strategies, avoid inappropriate therapy and better understand local epidemiology as pertussis and related infections resurge across age groups.
Supporting faster, more precise care decisions amid rising cases
Whooping cough is a cyclical disease that typically peaks every three to five years, and current surges are being amplified by routine vaccine disruptions during the COVID-19 pandemic, waning immunity and vaccine hesitancy. Rising infection rates in older children and adults, where symptoms can be atypical, further complicate recognition and containment.
"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."
For health systems, deploying CLIA-waived testing directly at the point of care can reduce pressure on central laboratories, shorten time to isolation decisions and improve antimicrobial stewardship by ensuring macrolides and other antibiotics are targeted where they are most likely to benefit patients and communities.
Expanding the cobas® liat respiratory testing menu
The Bordetella assay extends the capabilities of the compact cobas® liat platform, which already supports point-of-care testing for SARS-CoV-2, Influenza A and B, RSV and Group A Streptococcus. The system is designed to deliver PCR-accurate, definitive results in 20 minutes or less, enabling clinicians to test for multiple respiratory pathogens during a single visit.
By consolidating rapid testing for viral and bacterial causes of cough and upper respiratory symptoms on one device, the expanded menu allows practices and emergency departments to build more efficient diagnostic algorithms and reduce unnecessary referrals and repeat visits. The newly cleared Bordetella test is expected to be particularly impactful during seasonal peaks and outbreak settings where timely differentiation from other respiratory infections is critical.
Strategic step in Roche's diagnostics and public health portfolio
For Roche, the launch reinforces its position as a global leader in in-vitro diagnostics and aligns with its strategy to bring high-performance molecular testing closer to the patient. Combining point-of-care PCR with a broadened respiratory panel helps healthcare providers respond more effectively to evolving infectious disease patterns, while supporting public health goals to limit transmission and protect high-risk populations.
For full information about Roche's new Bordetella point-of-care test and the cobas® liat diagnostics portfolio, visit https://www.roche.com.