Roche’s point-of-care polymerase chain reaction (PCR) test for pertussis (whooping cough) and other Bordetella infections has received 510(k) clearance from the US Food and Drug Administration (FDA) and CE In Vitro Diagnostic Medical Devices Regulation (IVDR) certification.
The test also secured a Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver.
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
Designed to run on the cobas liat system, the test is said to deliver results in 15 minutes and can be used in the practices of general practitioners and emergency settings.
According to Roche, this rapid turnaround allows healthcare professionals to diagnose patients at the time of consultation, potentially enabling prompt administration of antibiotics and reducing the risk of complications and further transmission.
The test identifies and differentiates between three main Bordetella species: B. pertussis, which causes classic whooping cough; B. parapertussis, responsible for a milder illness that may be unresponsive to standard treatments; and the B. holmesii pathogen that presents with symptoms akin to pertussis and poses diagnostic challenges.
Roche Diagnostics CEO Matt Sause said: “Faster and more accurate clinical decisions are critical for reducing the risk of severe complications and ultimately stopping the transmission of Bordetella infections.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalData“This new test allows clinicians to quickly make a definitive and precise diagnosis to ensure patients get the right treatment earlier.”
Roche noted that Bordetella infections, along with whooping cough, are difficult for clinicians to diagnose because early symptoms resemble those of other respiratory infections.
This new assay adds to the cobas liat system’s existing portfolio, which includes tests for Influenza A and B, SARS-CoV-2, respiratory syncytial virus (RSV), and Group A Streptococcus (Strep A).
In October 2025, Roche received CE mark approval for its Elecsys Dengue Ag test, a fully automated immunoassay for diagnosing acute dengue infection. This test detects the non-structural protein 1 (NS1) antigen in human serum and plasma, which is a key indicator of acute infection in the early days of illness.
