Great Basin Scientific, a molecular diagnostics company, announced it has received US Food and Drug Administration (FDA) 510(k) clearance for its Stool Bacterial Pathogens Panel (SBPP). More than 40 hospitals and labs are currently evaluating or are scheduled to evaluate SBPP, the company’s second mid-plex panel. These evaluations alone represent the potential for nearly $2.0 million in annual revenue for the company, which historically has had an 82% win rate for its product evaluations. With this FDA clearance, the company will begin to actively market SBPP to its current customer base of over 230 hospitals and labs, and will commence aggressive outreach to potential new customers. Sites that have evaluated and are ready to adopt the panel can now purchase kits to report patient results.
“The Stool Bacterial Pathogens Panel is a milestone product for both the market and Great Basin, as this is one of the first molecular diagnostic panels available that meets the emergent reimbursement recommendations for smaller, truly syndromic panels,” said Ryan Ashton, co-founder and chief executive officer of Great Basin Scientific. “The market demand for right-sized panels is rapidly growing as evidenced by the fact that, before we received clearance and were allowed to market SBPP, our customers contacted us requesting investigational use evaluation of the panel. As a result, SBPP currently comprises 25% of all new product evaluations and 40% of the estimated potential revenue in our previously announced $5.0 million New Business Pipeline. We are excited to begin actively marketing this panel, which is priced below likely reimbursement rates, and expect demand for SBPP to add additional revenue for the Company, with significant revenue growth from the product expected later in 2017 and early 2018. We also anticipate that with its higher ASP and strong gross margins, SBPP will be a key contributor to Great Basin’s profitability goals.”
SBPP addresses a significant unmet need for an affordable panel that quickly and accurately diagnoses patients suffering from food-borne gastrointestinal distress. The assay is designed to simultaneously detect Salmonella species, Shigella species, Shiga Toxin-producing E. coli (stx1, stx 2, O157 serotype-specific genes), and Campylobacter species (C. jejuni and C. coli), key bacterial pathogens that make up nearly 95% of all food-borne illnesses in the US. SBPP supports lab and clinician needs with an easy-to-use workflow of less than two minutes hands-on steps, an on-demand system, and a turnaround time of under two hours, compared to conventional tests that are labor intensive, requiring multiple individual tests with poor sensitivity and long turnaround times (96 hours).
According to the Centers for Disease Control, there are 48 million food-borne illnesses in the US annually, representing a significant portion of what the Company estimates to be an $800 million market for diagnostic testing solutions for gastro-intestinal distress. SBPP addresses this large market where current solutions are either too slow or too expensive relative to reimbursement rates. Considered a “right-sized” panel, SBPP produces a definitive result in under two hours, with under one minute of hands-on time, compared with conventional laboratory methods requiring extensive hands-on labor and 3-4 days of processing time to obtain a definitive result, or mega-panels that include analytes that are unnecessary and, consequently, have a higher rate of reimbursement denial.
“Clinicians have indicated to us they prefer a more targeted, therapy-focused approach to diagnostic testing over the high-priced mega-panels used in capital-intensive systems that have higher reimbursement resistance from payors,” said Sandra Nielsen, senior vice president of sales and marketing. “Further, labs are looking for ways to streamline workflow and cut costs without compromising patient safety. SBPP uniquely addresses all these needs, as demonstrated by the unexpected requests from our current customers to evaluate the panel prior to clearance. We are pleased to be able to serve current and new customers and their patients with this unique product offering, the demand for which we believe validates Great Basin’s investment in delivering right-sized panels that better meet the call for cost-effective, accurate and easy-to-use diagnostics.”
As announced in the company’s Business Update on June 26, 2017, the Company had approximately $5.0 million of potential new revenues in the new business pipeline, of which SBPP comprises nearly $2.0 million. These potential revenue estimates, as well as those below are based on the evaluating site’s own estimate of their expected testing volumes multiplied by the product price offered to the prospective customer.
To the extent these evaluations and scheduled evaluations are converted into customers, the company expects such conversions to begin immediately with further strong customer and revenue growth to occur between the fourth quarter of 2017 and the first quarter of 2018. The company’s historical “win rate” (those evaluations that elect to become customers) has been 82%.
Great basin scientific, us fda clearance, stool bacterial pathogens panel
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