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Great Basin Receives FDA Clearance for Stool Bacterial Pathogens Panel

NEW YORK (GenomeWeb) – Great Basin said today that it has received 510(k) clearance from the US Food and Drug Administration for its stool bacterial pathogens panel, which "addresses a significant unmet need" for an affordable panel that quickly and accurately diagnoses patients suffering from food-borne gastrointestinal distress.

Great Basin noted that its assay simultaneously detects Salmonella, Shigella, Shiga Toxin-producing E. coli, and Campylobacter — bacterial pathogens that make up nearly 95 percent of all food-borne illnesses in the US.

The firm said that more than 40 hospitals and labs are either evaluating or scheduled to evaluate the panel, and noted that these evaluations alone represent the potential for nearly $2.0 million in annual revenue.  

With the FDA clearance, sites that have evaluated the panel and are ready to adopt it can purchase kits to report patient results.

The firm said that it will begin to market the stool bacterial pathogens panel to a customer base of more than 230 hospitals and labs, and will approach potential new customers.

Ryan Ashton, cofounder and CEO of Great Basin Scientific, said that the stool bacterial pathogens panel "is one of the first molecular diagnostic panels available that meets the emergent reimbursement recommendations for smaller, truly syndromic panels," and added that the panel is "priced below likely reimbursement rates."

The firm said that it expects that demand for the panel is likely to yield "significant revenue growth from the product" later in 2017 and early 2018, and that it will "be a key contributor to Great Basin's profitability goals."

The firm noted that the panel supports lab and clinician needs with an easy-to-use workflow of less than two minutes hands-on time, an on-demand system, and a turnaround time of less than two hours, compared to about 96 hours and a labor-intensive workflow with conventional tests.