Roche receives FDA clearance for rapid 15-minute pertussis PCR test

USA—Roche has secured regulatory approval for its point-of-care polymerase chain reaction (PCR) test designed to detect pertussis, commonly known as whooping cough, along with other Bordetella infections.

The US Food and Drug Administration (FDA) granted the test 510(k) clearance, while European regulators provided CE In Vitro Diagnostic Medical Devices Regulation (IVDR) certification.

Additionally, the test obtained a Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver, expanding its accessibility across various healthcare settings.

Healthcare providers can run the diagnostic test on Roche’s cobas liat system, which delivers results in just 15 minutes.

The rapid turnaround time makes the test particularly valuable in general practitioner offices and emergency departments where quick decision-making is essential.

Physicians can now diagnose patients during their initial consultation rather than waiting days for traditional laboratory results.

This immediacy allows doctors to prescribe antibiotics promptly when necessary, potentially reducing both serious complications and the spread of infection to others.

The test distinguishes between three distinct Bordetella species that cause different types of illness.

It identifies B. pertussis, the bacterium responsible for classic whooping cough with its characteristic severe coughing fits.

The assay also detects B. parapertussis, which produces a milder form of the disease that may not respond to standard antibiotic treatments.

Furthermore, the test recognizes B. holmesii, a pathogen that creates diagnostic challenges because it produces symptoms similar to pertussis but requires different clinical management.

Matt Sause, CEO of Roche Diagnostics, emphasized the clinical importance of rapid diagnosis in managing these infections.

He noted that faster and more accurate clinical decisions play a critical role in preventing severe complications and halting transmission chains.

The test enables clinicians to make definitive diagnoses quickly, ensuring patients receive appropriate treatment without delay.

Diagnosing Bordetella infections presents significant challenges for healthcare providers because early symptoms closely resemble those of common respiratory infections like colds or the flu.

Patients typically experience runny nose, mild fever, and occasional cough before the distinctive whooping cough pattern emerges.

This similarity often leads to delayed diagnosis and continued disease transmission.

The new pertussis assay joins Roche’s growing portfolio of rapid diagnostic tests available on the cobas liat system.

The platform already offers tests for influenza A and B, SARS-CoV-2, respiratory syncytial virus (RSV), and Group A Streptococcus (Strep A).

In October 2025, Roche expanded its diagnostic capabilities further when it received CE mark approval for its Elecsys Dengue Ag test.

This fully automated immunoassay detects the non-structural protein 1 (NS1) antigen in human serum and plasma, serving as a key indicator of acute dengue infection during the critical early days of illness.