Roche has secured regulatory green lights in both the U.S. and Europe to begin shipping its first point-of-care test for whooping cough amid a worldwide surge in cases and the recent deaths of infants in Kentucky.
Designed for use in doctor’s offices, clinics and emergency rooms, the diagnostic aims to deliver results in fewer than 15 minutes through the company’s cobas liat rapid PCR testing system.
Also known as pertussis, whooping cough is caused by a highly contagious bacteria, with peak numbers of cases typically coming in cycles every three to five years. The disease can be prevented with vaccines during pregnancy, infancy and booster shots later in life.
According to the Pan American Health Organization, while about 4,100 cases were reported in North, South and Central America during 2023, that number exploded to more than 43,000 in 2024—and high numbers of cases have continued into this year as the rate of vaccinations has dropped. The PAHO has also reported the emergence of antibiotic-resistant strains.
Most recently, the state of Kentucky reported at least 566 cases and its third unvaccinated infant death from the disease after not recording an infant death since 2018, according to the University of Minnesota’s Center for Infectious Disease Research and Policy, known as CIDRAP.
The center said more than 25,000 cases of whooping cough have been reported in the U.S. this year so far—including a high point of at least 3,500 in Texas, with that state seeing two infant deaths.
Roche’s test—which received a CE mark approval in Europe and a 510(k) clearance from the FDA, with a laboratory waiver allowing it to be used on the front lines of care—checks for the main culprit of whooping cough, the bacteria Bordetella pertussis, as well as the bug B. parapertussis, which causes a milder illness that may not respond to standard treatments, and the emerging pathogen B. holmesii that can bring similar cough symptoms.
The assay can be used on the cobas liat system alongside respiratory diagnostics for SARS-CoV-2, the virus behind COVID-19, in addition to tests for influenza A, influenza B, respiratory syncytial virus and group A streptococcus, or strep throat. The platform also received FDA clearances earlier this year for multiplex assays for sexually transmitted infections.