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Global biotech company Roche has today announced that its first point-of-care diagnostic test for whooping cough (pertussis) and other Bordetella infections has received U.S. FDA 510(k) clearance, a CLIA (Clinical Laboratory Improvement Amendments of 1988) waiver, and CE IVDR(In Vitro Diagnostic Medical Device Regulation) certification.

The innovative PCR-based test, designed for use on the cobas® liat system, provides results in just 15 minutes within GP practices and Emergency Rooms—allowing clinicians to diagnose during the patient visit and immediately initiate appropriate antibiotic treatment to prevent serious complications and further transmission.

About the cobas® liat system

The cobas® liat system is widely used worldwide for point-of-care molecular diagnostics. It delivers PCR-accurate results in 20 minutes or less, supporting faster clinical decisions.

The new Bordetella assay expands the system’s respiratory testing menu, which already includes assays for SARS-CoV-2, Influenza A/B, Respiratory Syncytial Virus (RSV), and Group A Streptococcus (Strep A).

By enabling comprehensive respiratory testing during the patient consultation, the system enhances rapid decision-making and reduces dependence on central laboratory services.

About Pertusis

Pertussis affects people across all age groups but is particularly dangerous for children, with an estimated 24.1 million cases and 170,000 deaths globally each year.

Early symptoms often mimic other respiratory infections, making rapid, accessible testing crucial.

Without timely diagnostics, clinicians frequently rely on symptom-based treatment, which can delay care and worsen outcomes, especially for high-risk patients.

What was said

“Fast and precise clinical decisions are essential to reducing severe complications and stopping the spread of Bordetella infections,” said Matt Sause, CEO of Roche Diagnostics. “This new test enables clinicians to make a clear and accurate diagnosis so patients can receive the right treatment sooner.”

The assay detects and differentiates three important Bordetella species:

• B. pertussis – the primary cause of whooping cough
• B. parapertussis – responsible for a milder, pertussis-like illness that may not respond to standard therapy
• B. holmesii – an emerging pathogen increasingly linked to pertussis-like symptoms and diagnostic uncertainty

Whooping cough follows a cyclical pattern, peaking every three to five years. The current global increase in cases has been intensified by disruptions to routine immunization during the pandemic, waning immunity, and rising vaccine hesitancy.

This has led to more infections across all age groups, including older children and adults whose symptoms can be atypical and easily overlooked.

Because early Bordetella symptoms resemble other respiratory illnesses, reliable and rapid identification is essential for administering effective treatment and ensuring timely care.

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