Specific Diagnostics announced formation of its US commercial sales, service, support and marketing teams in anticipation of the launch of the Reveal Rapid AST System for blood infection samples. Following 11 studies across France and England comprising over 1,400 clinical positive blood culture samples, yielding overall accuracy of 97.8%, and in tandem with the commencement of clinical and analytical studies in preparation for 510(k) submission to the FDA, Specific’s commercial team will be engaging with leading lab directors across the US to introduce them to the rapid turn-around, ease of use, broad antibiotic menu, high throughput and low cost of the Reveal rapid AST system.
“Our successful European launch, with 11 validation studies across France and England that have been completed or are now finishing, gives us confidence that we are very much ready for FDA clinical studies, as we move to introduce Reveal in the US,” said Jeff Holman, VP of Global Marketing for Specific. “With clinical trials underway, we want to be informing microbiology leaders who might wish to be early evaluators of our technology in the US.”
Specific Diagnostics has filled roles for heads of US sales, service, deployment and training to begin organizing customer-facing teams in preparation for early demand access to the Reveal system, and to support Specific’s creation of “Reveal Centers of Excellence” at select nationally recognized microbiology labs. Details of an early access program will be announced early in the new year.
“Our strategy to first launch in Europe has paid off,” said Dr. Paul A. Rhodes, CEO of Specific. “The excellent results produced by all these sites in France and England along with the ease-of-use established by these labs has prepared us for entry into the US market. The US commercial team we have formed will have their hands full introducing Reveal to leading US microbiology labs. They all have adopted some form of rapid ID for blood infections and want an affordable solution for rapid AST to be able to rapidly act for the benefit of patients.