Basel, Switzerland, December 2, 2025 —Roche has announced the launch of a rapid 15-minute point-of-care PCR test capable of detecting and differentiating major Bordetella species, including B. pertussis, the primary cause of whooping cough. The assay has received FDA 510(k) clearance, a CLIA waiver for decentralized U.S. use, and CE-IVDR certification in Europe, marking a major expansion of Roche’s cobas® liat portfolio for respiratory diagnostics. The newly launched test is designed to detect B. pertussis, B. parapertussis and B. holmesii, pathogens that often mimic common respiratory infections in their early stages. Because clinical symptoms frequently overlap with viral illnesses, diagnosis is often delayed. Roche’s new assay provides PCR-level accuracy at the point of care, enabling clinical teams to diagnose whooping cough during the first consultation and initiate treatment immediately. This is a crucial step for improving patient outcomes and limiting infectious spread, especially among infants and vulnerable populations.

Science Significance

Delivering PCR-accurate molecular diagnostics in just 15 minutes represents a significant technological advance. The test uses real-time nucleic-acid amplification integrated into a compact, automated platform that requires minimal operator training. By enabling the detection of multiple Bordetella species, the assay enhances diagnostic precision and supports improved outbreak tracking and antimicrobial stewardship. Rapid molecular testing at decentralized points of care can profoundly reduce misdiagnosis rates and limit unnecessary antibiotic prescribing, advancing the scientific standard for respiratory pathogen management.

Regulatory Significance

The test’s FDA 510(k) clearance and CLIA waiver represent strong regulatory validation of its reliability, usability and suitability for decentralized settings such as urgent-care centres, primary-care clinics and emergency departments. The CE-IVDR designation ensures compliance with Europe’s updated and more stringent in-vitro diagnostic regulatory framework, confirming the test’s analytical quality, performance and safety. These approvals showcase a meaningful shift toward wider adoption of point-of-care molecular diagnostics, aligning with regulatory trends worldwide.

Business Significance

For Roche, expanding the cobas® liat test menu reinforces its leadership in molecular diagnostics and creates a more comprehensive offering for respiratory-pathogen management. The adoption of rapid point-of-care PCR solutions continues to grow following the global shift toward decentralized testing during the COVID-19 era. By providing clinicians with fast, reliable tools, Roche strengthens its market position across both acute-care and outpatient sectors. The new assay is expected to drive increased demand for the cobas® liat platform, boosting recurring revenue from consumables and test cartridges.

Patients’ Significance

For patients — particularly infants, children, older adults and those with underlying health conditions — rapid identification of Bordetella infections can significantly reduce complications, accelerate appropriate antibiotic treatment and prevent severe disease. Immediate results reduce the burden of unnecessary treatments, hospital admissions and prolonged diagnostic uncertainty. Rapid, accurate diagnosis also limits community transmission, providing broader public-health protections.

Policy Significance

Roche’s test aligns with global public-health policies promoting diagnostic accessibility, antimicrobial stewardship and strengthened outbreak response. By decentralizing PCR-level diagnostics, health systems can improve surveillance, identify cases earlier and deploy resources more efficiently. The adoption of such technologies supports long-term policy goals toward robust respiratory-pathogen management infrastructures and more resilient diagnostic networks across regions.

Roche’s introduction of a 15-minute PCR-accurate Bordetella test represents a significant advancement in respiratory diagnostics, offering rapid, actionable results at the point of care. By combining scientific innovation, regulatory readiness and clinical utility, the new assay stands to improve individual patient outcomes while supporting broader public-health goals of timely diagnosis and effective disease control.

Source: Roche press release