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)

Core Insights - Roche has received FDA 510(k) clearance and CLIA waiver for its first point-of-care test for whooping cough and Bordetella infections, which provides results in just 15 minutes [1][3] - The test can differentiate between three Bordetella species, allowing for more accurate diagnoses and timely treatment [3][8] - The rise in whooping cough cases is attributed to pandemic-related vaccination interruptions, waning immunity, and vaccine hesitancy, affecting all age groups [4][5] Company Overview - Roche, founded in 1896, is the world's largest biotechnology company and a leader in in-vitro diagnostics, focusing on scientific excellence to improve healthcare [7] - The cobas® liat system, used for the new test, is already established in point-of-care diagnostics and enhances the speed and accuracy of clinical decisions [6][8] - Roche is committed to sustainability and aims to achieve net zero by 2045, reflecting its long-standing dedication to societal contributions through innovative healthcare solutions [9]