By: IPP Bureau
Last updated : December 04, 2025 3:36 pm
The PCR-based test, delivered via Roche’s cobas liat system, allows results to be obtained during a patient consultation in GP practices and Emergency Rooms
Swiss pharma giant Roche has announced a major advance in the fight against whooping cough and other Bordetella infections.
Its first point-of-care test has received US FDA clearance, a CLIA waiver, and CE IVDR certification, enabling physicians to diagnose infections in just 15 minutes.
The PCR-based test, delivered via Roche’s cobas liat system, allows results to be obtained during a patient consultation in GP practices and Emergency Rooms. This rapid turnaround helps clinicians prescribe appropriate antibiotics immediately, potentially preventing severe complications and halting transmission.
“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.”
Pertussis affects people of all ages but is especially dangerous for children, causing an estimated 24.1 million cases and 170,000 deaths worldwide each year. Early symptoms are often indistinguishable from other respiratory illnesses, leaving doctors to treat patients based on symptoms alone—a delay that can worsen outcomes.
The new test not only identifies Bordetella infections but also differentiates between three key species: B. pertussis, which causes classic whooping cough; B. parapertussis, which produces milder symptoms that may resist standard treatments; and B. holmesii, an emerging pathogen linked to pertussis-like illness and diagnostic challenges.
Whooping cough typically spikes every three to five years, and the current surge has been intensified by pandemic-related vaccination disruptions, waning immunity, and vaccine hesitancy. Infections are spreading across all age groups, including older children and adults, where symptoms can be atypical and hard to recognize.
The cobas liat system is already widely used for rapid point-of-care diagnostics, delivering PCR-accurate results in 20 minutes or less.
The new assay expands its capabilities, complementing existing respiratory tests for SARS-CoV-2, Influenza A and B, RSV, and Group A Streptococcus. By enabling same-visit testing for multiple conditions, Roche aims to empower clinicians to make faster, more confident care decisions while reducing dependence on central laboratories.