Roche receives FDA clearance for its first POC test for diagnosing Bordetella infections
The point-of-care test detects and differentiates between three types of Bordetella infection that can cause similar cough symptoms, ensuring patients receive the right diagnosis at the earliest opportunity
8 Dec 2025
Roche has announced that its first point-of-care test for the diagnosis of whooping cough (pertussis) and other Bordetella infections, has been granted U.S. Food and Drug Administration (FDA) 510(k) clearance and Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver, in addition to CE IVDR certification.
The test not only detects Bordetella infections but also differentiates between three key species: B. pertussis, the cause of classic whooping cough; B. parapertussis, which causes a milder pertussis-like illness that may not respond to standard treatments; and B. holmesii, an emerging pathogen increasingly associated with pertussis-like symptoms and potential diagnostic challenges.
The PCR test uses the cobas® liat system to deliver results in just 15 minutes in GP practices and emergency rooms. This speed enables physicians to diagnose patients during their consultation and take immediate action to provide appropriate antibiotics that can prevent severe complications and onward transmission, and reduces reliance on central laboratory facilities.
This new assay expands the cobas® liat system’s capabilities, complementing existing respiratory assays for the detection of SARS-CoV-2, influenza A, influenza B, respiratory syncytial virus (RSV), and group A Streptococcus (Strep A).
Bordetella infections, including whooping cough, are a significant challenge for clinicians due to the similarity of early symptoms to other respiratory infections. Accurately identifying Bordetella among these conditions is essential to delivering the right treatment and ensuring timely intervention.
"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."
