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 has received FDA 510(k) clearance and CLIA waiver for its new point-of-care test for Bordetella infections, including whooping cough. This groundbreaking PCR test delivers accurate results in just 15 minutes using the cobas® liat system. It enables healthcare providers to diagnose and treat patients rapidly in GP practices and emergency rooms. The test can differentiate between three key Bordetella species, crucial for effective treatment. Early and precise diagnosis is vital for preventing severe complications, especially in vulnerable populations like infants and the elderly. Whooping cough, a cyclical and potentially deadly disease, presents diagnostic challenges due to symptoms mimicking other respiratory illnesses. Current diagnostic limitations can lead to delayed treatment and worse outcomes. This new test empowers clinicians to make faster, definitive decisions during patient consultations. It expands the cobas® liat system's capabilities, which already tests for other respiratory pathogens. Roche aims to improve patient care by transforming healthcare delivery through innovative diagnostics and medicines.