NEW YORK (GenomeWeb) – Great Basin Scientific announced today that it has completed a clinical trial and 510(k) submission to the US Food and Drug Administration for its Bordetella Direct Test for Bordetella pertussis, the infectious agent that causes whooping cough. The company is also seeking a CE mark for the test.
The "sample-to-result" PCR-based test detects B. pertussis bacteria directly from a patient nasopharyngeal swab and runs using a fully-enclosed assay cartridge on the firm's diagnostic system, requiring less than one minute of hands-on time.
There are about 16 million cases and 195,000 deaths caused by whooping cough per year, according to the US Centers for Disease Control and Prevention.
"Pertussis is a very contagious disease and the incidence is steadily rising," Sandra Nielsen, Great Basin's senior vice president of sales, marketing, and human resources, said in a statement. "We look forward to serving our customers with a valuable and cost-effective tool that provides faster and more accurate results over culture-based tests for life-threatening and life-changing diseases, like pertussis."
Great Basin also recently submitted its Stool Bacterial Pathogens Panel to the FDA. The firm noted that it will have six commercial assays on the market once that panel and the pertussis assay are cleared. It also has three additional assays in development.