Roche has received FDA 510(k) clearance and CLIA waiver for its new point-of-care test for Bordetella infections, including whooping cough. This innovative PCR test, utilized with the cobas® liat system, delivers accurate results in just 15 minutes. This rapid diagnosis allows healthcare providers to take immediate action, preventing severe complications and the spread of the illness. The test uniquely differentiates between three Bordetella species, ensuring precise identification of the cause of respiratory symptoms. Early and accurate diagnosis is particularly crucial for vulnerable populations like infants and the elderly. Whooping cough, a significant public health concern, is currently experiencing a surge exacerbated by vaccination interruptions. The test's ability to diagnose during a single consultation reduces reliance on central labs and speeds up treatment decisions. This advancement complements existing assays for other respiratory pathogens on the cobas® liat platform. Roche aims to transform healthcare delivery through pioneering diagnostics and medicines for better patient outcomes. The test's speed and accuracy are vital in combating the challenges posed by Bordetella infections.