NEW YORK (GenomeWeb) – Great Basin announced today that its Bordetella Direct assay has received CE Marking.
The PCR-based test to detect Bordetella pertussis was granted 510(k) clearance by the US Food and Drug Administration earlier this year and will now be launched commercially.
"Bordetella Direct represents a continuation of our strategy to bring to market high value tests that we expect will improve gross margins as they become a significant part of our revenues," Great Basin Cofounder and CEO Ryan Ashton said in a statement.
The Bordetella Direct test runs on the firm's molecular diagnostic platform, which also run its STEC, Group B Strep, and Toxigenic Clostridium difficile assays, and Staph Blood Culture Panel for identifying methicillin-resistant Staphylococcus aureus and other Staphylococcus species bloodstream infections.
The test was cleared by the FDA in less than two months. "The processes we put in place that resulted in a swift FDA clearance also supported our ability to quickly commercialize the Bordetella Direct test, much to the relief of many of our customers. Immediately after announcing FDA clearance, several hospitals contacted us requesting immediate access to the assay in order to respond to the testing demands from local pertussis outbreaks," Ashton added.
While some labs have adopted in-house molecular diagnostic testing for Bordetella, commercial options are "a choice of expensive panels that test for a wide variety of unrelated respiratory issues or more cost-effective, but labor-intensive stand-alone tests," according to Sandra Nielsen, senior vice president of sales and marketing for Great Basin. "We believe that our solution offers the best of all worlds — an easy-to-use, cost-effective test that provides an answer in less than two hours."