SOUTH SAN FRANCISCO (dpa-AFX) - Roche Holding AG (RHHBY) on Tuesday said its point-of-care test for diagnosing whooping cough, or pertussis, as well as other Bordetella infections, has received U.S. Food and Drug Administration (FDA) 510(k) clearance and a Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver, alongside CE IVDR certification.
The PCR-based assay, designed for use on Roche's cobas liat system, can detect and differentiate between three types of Bordetella infections that often present with similar cough symptoms. The test delivers results in about 15 minutes.
Pertussis affects people of all ages but is particularly severe in children, contributing to an estimated 24.1 million cases and 170,000 deaths each year.
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