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03 Dec 2025
Admin
News Article

Roche Launches 15-Minute Point-of-Care Test for Whooping Cough: A Big Step for Faster, Accurate Diagnosis

Roche has secured FDA 510(k) clearance, a CLIA waiver, and CE IVDR certification for its first point-of-care PCR test for whooping cough and other Bordetella infections. The test runs on the cobas liat system and delivers results in just 15 minutes.

This speed changes everything. Clinicians can now diagnose patients during the consultation and start treatment immediately

Why Rapid Diagnosis Matters?

Pertussis affects people of all ages. But it hits children the hardest, causing 24.1 million cases and 170,000 deaths each year.

The biggest challenge? Early symptoms often copy common respiratory infections, making diagnosis slow and uncertain. This delay allows the disease to worsen and increases community spread.

What Roche Says?

“Faster and more accurate clinical decisions are critical,”
— Matt Sause, CEO, Roche Diagnostics

He highlights how the new test enables clinicians to deliver the right treatment earlier, preventing complications and reducing transmission.

What the Test Can Detect?

The assay differentiates between three key Bordetella species:

B. pertussis — classic whooping cough
B. parapertussis — milder illness, often less responsive to standard therapy
B. holmesii — an emerging pathogen that complicates diagnosis

This level of precision helps clinicians avoid misdiagnosis and choose the right antibiotics faster.

A Growing Public Health Challenge

Whooping cough is cyclical and peaks every three to five years. A surge is underway now.

Several factors are driving the rise:

Interrupted childhood vaccination schedules
Waning immunity
Vaccine hesitancy
Less typical symptoms in older children and adults

These challenges have created urgent demand for fast, accessible testing.

The cobas liat System: Fast, Compact, Point-of-Care

The cobas liat platform is already widely used for respiratory infections. It delivers PCR-accurate results in 20 minutes or less.

This new Bordetella assay expands its existing menu, which includes:

SARS-CoV-2
Influenza A
Influenza B
RSV
Group A Streptococcus

Clinicians can now test for multiple conditions in real time, without relying on central labs.

About Roche

Founded in 1896, Roche has grown into the world’s largest biotechnology company and a global leader in in-vitro diagnostics. Its mission remains clear: pursue scientific excellence and develop tools that save and improve lives.

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