Specific Technologies announces new results and a major new NIAID grant award

January 4, 2016 – MOUNTAIN VIEW, California Specific Technologies, which has developed a new diagnostic paradigm combining detection with ID of microorganisms growing in culture, today announces development of a new paradigm for the quantitative determination of antibiotic efficacy, within hours of positive blood culture, with minimal sample preparation and at a low cost. Together with the SpecID blood culture system, this antibiotic susceptibility testing (AST) system, SpeciFAST, offers phenotypic MIC matching CLSI gold standard results, in most cases within 3 hours from positive blood culture, while greatly simplifying workflow, and all at the cost of current practices which take days longer.

The new technology, initially developed for use directly with positive blood culture samples (it does not require removal of red blood cells), is equally suited for use with standard emulsions obtained from colonies, making it a candidate replacement platform for legacy systems in modern microbiology laboratories.

In conjunction with the announcement of this innovation, Specific Technologies has received notice of a new $2.9M National Institutes of Health award for development of this antibiotic susceptibility testing (AST) system. This is the fourth grant the Company has received from the NIH for the development of a disruptive system to increase the speed of time-to-answer for blood infection, a life-threatening condition where time is of the essence, even while reducing lab cost.

"The alarming increase in antibiotic resistant infections combined with a dearth of new antibiotics has increased the demand for rapid, reliable and affordable antibiotic susceptibility determination," said Gary Procop, Director of Molecular Microbiology, Virology, Mycology and Parasitology at the Cleveland Clinic Foundation. "We look forward to working with Specific to evaluate this promising new technology, and are delighted that NIAID has seen fit to so strongly support this work."

In awarding this funding, the NIAID study section concluded, "The panel agreed that the proposed antimicrobial susceptibility testing platform with better sensitivity and speed of detection compared to existing methods is of high biomedical significance and clinical impact because of its potential to improve detection, treatment, monitoring, and surveillance of microbial antibiotic resistance that can impact the overall antibiotic stewardship and reduce the global trends of emerging antibiotic microbial resistance, mortality, and healthcare costs. A significant clinical need, promising technology, convincing scientific premise based on impressive preliminary data, and high probability of success are strengths of this application. Moreover, thoughtful commercialization strategy, rigorous scientific and engineering design, and well-planned clinical collaborations are strengths."

"These new developments and recent grant award further demonstrate the broad and disruptive capabilities of our underlying technology for microbiology diagnostics," said Paul A. Rhodes, Ph.D., CEO of Specific Technologies. "We are developing a truly new diagnostic paradigm, based on the ability to monitor the unique pattern of volatiles emitted by all growing microorganisms. The impact is faster detection and ID of samples, and with SpeciFAST the fastest system yet-announced for phenotypic MIC determination."

"Our paradigm will be cost-effective, simple and easy to integrate into existing lab practice," said Rob Lozuk, President of Specific Technologies. "We have initiated collaborations with global thought leaders to accelerate development of this disruptive capability and look forward to broadly commercializing both SpecID and SpeciFAST."

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About the SpecID System

During growth in culture, bacteria produce small molecule volatile metabolites unique to their species and strain. Utilizing a chemical fingerprint that combines detection and identification into a simple, automated single step using a low-cost disposable printed sensory array, the novel SpecID system identifies microorganism species and strain from the metabolomic signature of volatiles produced during growth.

About Specific Technologies

Specific Technologies has developed in vitro diagnostic systems based upon a unique, patented metabolomic signature technology that enables rapid identification of microorganisms. Its first commercial application applies this fundamental new platform to the detection and characterization of microorganisms causing blood stream infection, and to the rapid and low cost phenotypic determination of their antibiotic susceptibility. Specific Technologies is based in Mountain View, CA.

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