Roche receives FDA clearance with CLIA waiver and CE Mark for its first point-of-care test for diagnosing Bordetella infections, including whooping cough (pertussis)

Roche announced  that its first point-of-care test for the diagnosis of whooping cough (pertussis) and other Bordetella infections, has been granted FDA 510(k) clearance and Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver, in addition to CE IVDR certification. The groundbreaking PCR test uses the cobas liat system to deliver results in just 15 minutes in GP practices and Emergency Rooms. The cobas liat system is  already used by healthcare professionals worldwide for point-of-care diagnostics. The compact system delivers PCR-accurate definitive results in 20 minutes or less to aid in patient care decisions. 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).  By enabling clinicians to test for a range of conditions during the patient consultation, the system empowers faster, more decisive care decisions and reduces reliance on central lab facilities.

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.

“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.”