Roche Launches Groundbreaking 15-Minute Point-of-Care Test for Whooping Cough and Other Bordetella Infections, Receiving FDA Clearance, CLIA Waiver, and CE Mark
Roche has announced U.S. Food and Drug Administration (FDA) 510(k) clearance and Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver—along with CE IVDR certification—for its first point-of-care (POC) test designed to diagnose whooping cough (pertussis) and related Bordetella infections. The test, performed on Roche’s cobas® Liat system, delivers polymerase chain reaction (PCR)-accurate results in just 15 minutes, enabling clinicians in primary care settings and emergency departments to make immediate, life-saving decisions during a single patient visit.
This milestone marks a transformative shift in the management of Bordetella infections, which are notoriously difficult to diagnose in their early stages due to overlapping symptoms with common colds, influenza, and other respiratory illnesses. By offering rapid, precise, and species-specific detection at the point of care, Roche’s new diagnostic tool promises to reduce the burden of disease, prevent transmission, and improve outcomes—particularly among vulnerable populations such as infants, the elderly, and immunocompromised individuals.
A Timely Innovation Amid Rising Pertussis Cases
Whooping cough remains a persistent global health threat. According to the World Health Organization, pertussis accounts for an estimated 24.1 million cases and 170,000 deaths annually, with the majority occurring in unvaccinated or under-vaccinated children. However, the disease is far from eradicated in high-income countries. In fact, recent years have seen a resurgence driven by several converging factors: waning immunity from childhood vaccines, pandemic-related disruptions to routine immunization programs, and growing vaccine hesitancy.
Pertussis follows a cyclical pattern, typically peaking every three to five years. Health authorities in multiple countries, including the United States, have reported a notable uptick in cases in 2024–2025, signaling the onset of a new epidemic wave. Compounding the challenge, older children and adults—who often present with atypical or milder symptoms—can unknowingly serve as reservoirs for the bacteria, transmitting it to more vulnerable individuals, particularly unvaccinated infants for whom pertussis can be fatal.
Until now, diagnosing Bordetella infection has been a slow and cumbersome process. Traditional laboratory-based PCR testing, while highly accurate, can take 24 to 72 hours for results—delaying treatment and increasing the risk of complications and community spread. Culture methods, though specific, are even slower and less sensitive. As a result, many clinicians have been forced to rely on clinical judgment alone, often leading to misdiagnosis or delayed antibiotic therapy.
Roche’s new POC test directly addresses these diagnostic gaps. By bringing lab-quality PCR testing to the front lines of care, it allows physicians to confirm or rule out pertussis within minutes—while the patient is still in the exam room.
Precision Diagnostics: Differentiating Three Key Bordetella Species
One of the test’s most significant features is its ability not only to detect Bordetella DNA but also to differentiate among three clinically relevant species:
- Bordetella pertussis – The primary causative agent of classic whooping cough, characterized by severe, uncontrollable coughing fits and the distinctive “whoop” sound during inhalation.
- Bordetella parapertussis – Causes a milder, pertussis-like illness that may not respond to standard antibiotic regimens used for B. pertussis, necessitating different management strategies.
- Bordetella holmesii – An emerging pathogen increasingly implicated in respiratory infections with pertussis-like symptoms. Its presence can confound traditional diagnostic assays and may not respond to conventional pertussis treatments.
This level of differentiation is critical. Misidentifying one species for another can lead to inappropriate antibiotic use, prolonged illness, or unnecessary public health interventions (such as school or workplace quarantines). With Roche’s test, clinicians can tailor therapy based on the exact pathogen involved, improving patient outcomes and optimizing antimicrobial stewardship.
Enabling Immediate Clinical Action
The test’s 15-minute turnaround time on the cobas® Liat system—already deployed in thousands of clinics, urgent care centers, and emergency departments globally—means that diagnosis and treatment decisions can occur in real time. During a single office visit, a healthcare provider can collect a nasopharyngeal swab, run the test, and, if positive, prescribe appropriate antibiotics such as azithromycin or clarithromycin.
Early antibiotic intervention is especially crucial in pertussis. While antibiotics do not always shorten the duration of symptoms once the characteristic cough has developed, they are highly effective at reducing transmission when administered early in the disease course—typically within the first 1–2 weeks. Moreover, timely diagnosis allows for prompt post-exposure prophylaxis for close contacts, including household members and childcare providers, helping to contain outbreaks before they spread.
For infants—who are at the highest risk of severe complications such as pneumonia, seizures, and even death—early diagnosis can be lifesaving. Similarly, in elderly patients or those with underlying respiratory conditions like COPD, distinguishing pertussis from other infections prevents delays in supportive care and reduces hospitalization rates.
A Strategic Step in Roche’s POC Diagnostics Vision
Matt Sause, CEO of Roche Diagnostics, emphasized the broader implications of this launch: “Faster and more accurate clinical decisions are critical for reducing the risk of severe complications and ultimately stopping the transmission of Bordetella infections. This new test allows clinicians to quickly make a definitive and precise diagnosis to ensure patients get the right treatment earlier.”
The introduction of this Bordetella assay expands Roche’s growing portfolio of rapid molecular POC tests on the cobas® Liat platform, which already includes tests for influenza A/B, respiratory syncytial virus (RSV), group A strep, and SARS-CoV-2. By integrating multiple high-impact respiratory pathogens into a single, easy-to-use system, Roche is empowering frontline providers to manage complex diagnostic scenarios with confidence.
The CLIA waiver is particularly significant. It means the test can be performed in settings without full laboratory infrastructure—such as pediatrician offices, community clinics, and school-based health centers—dramatically expanding access to high-quality diagnostics in underserved areas.
Public Health Implications and Future Outlook
Beyond individual patient care, this test holds substantial public health value. Rapid, accurate diagnosis enables more effective surveillance, earlier outbreak detection, and targeted containment measures. In an era of increasing antimicrobial resistance and vaccine-preventable disease resurgences, tools that support precision diagnostics and appropriate antibiotic use are more important than ever.
Looking ahead, Roche’s innovation may also influence clinical guidelines. As POC molecular testing becomes more widespread, professional societies may update recommendations to emphasize testing over empirical treatment for persistent coughs, especially in high-risk settings like neonatal units or long-term care facilities.
Moreover, the success of this Bordetella assay could pave the way for future multiplex panels that simultaneously screen for a broader range of respiratory pathogens—further streamlining diagnosis during peak respiratory virus seasons.
Roche’s newly cleared point-of-care test for Bordetella infections represents a major leap forward in the fight against whooping cough and related illnesses. By delivering PCR-level accuracy in just 15 minutes and differentiating among three key bacterial species, it equips clinicians with the information they need to act swiftly, treat appropriately, and prevent transmission. At a time when pertussis cases are on the rise and diagnostic delays continue to jeopardize patient outcomes, this innovation arrives not a moment too soon. With regulatory approvals in both the U.S. and Europe, the test is poised to transform clinical practice and strengthen global efforts to control one of the most persistent—and preventable—infectious diseases of our time.
Source Link: https://www.roche.com/
