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Great Basin Whooping Cough MDx Clears FDA

NEW YORK (GenomeWeb) – Great Basin Scientific has received 510(k) clearance for a molecular diagnostic test to detect Bordetella pertussis, the bacteria that causes whooping cough.

The sample-to-result test, called Bordetella Direct, runs directly from a patient nasopharyngeal swab using a fully-enclosed assay cartridge on the firm's diagnostic system, requiring less than one minute of hands-on time.

It is also the fifth test on the firm's molecular diagnostics platform. Other tests include ones for Shiga toxin-producing Escherichia coli (STEC), Group B Streptococcus, Toxigenic Clostridium difficile, and a Staph Blood Culture Panel for identifying bloodstream infections caused by methicillin-resistant Staphylococcus aureus and other staphylococcus species.

The firm highlighted that the test received clearance in fewer than 60 days from submission. "We are pleased with the speed in which this test was cleared, and are further encouraged by the higher-than-expected demand from our customer base requesting immediate evaluations of Bordetella Direct," Ryan Ashton, co-founder and CEO of Great Basin, said in a statement.

The rapid clearance was attributed in part to the creation of a clinical affairs team tasked with streamlining the firm's clinical trial processes and strengthening its methods for presenting submissions to the FDA, with the objective of more rapidly and efficiently expanding its product menu, CTO Robert Jenison said.

Ashton said that children's hospitals are seeing a growing call for pertussis testing, while at the same time experiencing a reduction in reimbursements. "Our on-demand test is fast, easy-to-use, and cost effective, making it a compelling option to meet growing demands," he said.

Great Basin has struggled financially since being delisted from the Nasdaq, but the firm recently noted that it has been improving operational efficiencies and implementing cost management programs, including by restructuring. "We believe that Great Basin has a compelling menu of assays that, along with our no-cost instrumentation model and exceptional ease of use, should make us a convincing molecular diagnostics option for a wide variety of hospitals and labs in the US," Ashton said earlier this year.