FDA clears DiaSorin Bordetella test

Jan. 16, 2019—DiaSorin Molecular has received FDA clearance for its new Simplexa Bordetella Direct test. This CLIA moderate-complexity assay is designed for use on the Liaison MDX to provide qualitative detection and differentiation of Bordetella pertussis and Bordetella parapertussis. The assay is performed directly from nasopharyngeal swab samples without extraction and provides results in about an hour.

“We are very excited about our addition of the Simplexa Bordetella Direct assay as it will help in the detection and appropriate treatment of this infectious disease. The assay meets the needs of today’s laboratories by detecting both B. pertussis and B. parapertussis with a simple workflow,” Michelle Tabb, chief scientific officer for DiaSorin Molecular, said in a press release.