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DiaSorin Whooping Cough Test Clears FDA With Additional Claim

NEW YORK (GenomeWeb) – DiaSorin Molecular announced today that its assay to detect pathogens that cause pertussis, or whooping cough, has received clearance from the US Food and Drug Administration for an additional claim.

The Simplexa Bordetella Direct test kit detects and differentiates two gram-negative pathogens — Bordetella pertussis and Bordetella parapertussis — in fresh nasopharyngeal swab samples without a requirement for nucleic acid extraction. It provides results in about one hour. The moderate complexity test runs on the firm's Liaison MDx system, which also runs FDA-cleared assays for Clostridium difficile, herpes simplex virus 1 and 2, and Group B Strep.

The kit was initially cleared last year for detection from frozen nasopharyngeal swab specimens. According to a DiaSorin spokesperson, additional fresh samples were collected from five geographically diverse sites and compared to another FDA-cleared Bordetella pertussis nucleic acid amplification test.  The B. pertussis target showed 100 percent positive agreement and approximately 98 percent negative agreement. The B. parapertussis target, meanwhile, showed 100 percent positive and negative agreement compared to bi-directional sequencing.

Pertussis is a highly infectious illness that in severe cases can lead to hypoxia or death. Despite vaccinations, cases have increased in the US recently. Worldwide, in 2014 there were were 24 million cases and 160,700 deaths from pertussis in children under 5 years old, according to research published in Lancet.