Roche Secures FDA Clearance For 15-Minute Point-of-Care Test For Whooping Cough; New PCR Test Quickly Detects and Differentiates Bordetella Species

Roche has announced that its first point-of-care PCR test for detecting whooping cough (pertussis) and other Bordetella infections has received FDA 510(k) clearance, a CLIA waiver, and CE IVDR certification. The diagnostic runs on the cobas® liat system and delivers results in just 15 minutes, enabling immediate decision-making in clinics and emergency care settings. With this rapid turnaround, physicians can diagnose patients during the consultation and promptly initiate antibiotics, thereby reducing complications and preventing further transmission.

Pertussis remains a major global health concern, causing more than 24 million cases and 170,000 deaths each year, with young children being particularly vulnerable. Early symptoms closely resemble common respiratory illnesses, making diagnosis difficult without fast and accessible testing. As a result, treatment often begins late, increasing the risk of severe outcomes, especially in infants and other high-risk 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."

Beyond detecting infections, the new test differentiates between B. pertussis, B. parapertussis, and B. holmesii. This species-level accuracy is crucial because these pathogens can cause similar symptoms but may respond differently to standard therapies. B. holmesii, in particular, has emerged as a challenging pathogen due to its association with pertussis-like illness and potential to be overlooked.

Whooping cough follows a cyclical pattern, intensifying every three to five years. The current surge in cases has been exacerbated by disruptions to vaccination during the pandemic, declining immunity, and growing vaccine hesitancy. These factors have contributed to rising infections across all age groups, including children and adults who present with atypical symptoms that complicate clinical assessment. Roche’s rapid diagnostic aims to address this longstanding gap in early and accurate detection.