MOUNTAIN VIEW, California, June 13, 2016 -- Specific Technologies, which has developed a new paradigm combining detection with ID of microorganisms growing in culture, announces that it is among the first recipients of a grant under the new NIH SBIR Commercial Readiness Program. The $2.8M award builds upon a recently announced $2.9M Phase 2b SBIR award focused on the manufacture of the Spec80, Specific's 80-bottle clinical blood culture instrument. The CRP award bridges the gap between manufacture and regulatory clearance by funding the development of the quality and manufacturing systems required for regulatory submittal, along with the design and coordination of the analytical, preclinical and clinical trials required for regulatory review. Together this pair of recent awards reflects the judgment of expert study section reviewers that combining detection and ID of blood infection represents a much needed advance that will accelerate the detection and treatment of septicemia, which is among the most deadly conditions in terms of mortality rate, is the leading cause of death in hospitals, and is estimated to cost the US health care system over $20B per year.
Specific Technologies' new paradigm for blood culture not only furnishes detection faster than all present platforms, but uniquely integrates a Gram status determination more accurate than the bench-top stain, and highly accurate species ID all entirely hands free during culture. Because the system compresses what is now 3 steps in the microbiology laboratory into one automated instrument, it offers clinical microbiology laboratories reduced costs as well as faster answers and a streamlined workflow.
Specific is pleased to relay this continuing support from the NIH, which was awarded upon the recommendation of industry expert reviewers, each of whom is a leader in clinical microbiology and is well-familiar with all the alternative instruments and methods available for characterizing blood infection. As an indication of the level of excitement on the part of these experts, one Reviewer wrote: "The SpecID system is faster and cheaper than existing blood culture systems, but offers more value...the reviewer is excited about the development of this technology to replace current blood culture systems." Another wrote: "This system is a highly significant advance in blood culture, incorporating identification into the culture system..."
"We are grateful to the NIH for its continuing support of the development and now commercialization of our innovative paradigm combining detection with ID during culture. The level of enthusiasm among the expert Reviewers gives us confidence that the system we are developing will be well received by clinical laboratories," said Dr. Paul Rhodes, Chief Executive Officer of Specific Technologies. "Our fully automated system will streamline the lab work flow, reduce costs, and substantially shorten the time from sample arrival to the Gram status and species ID determinations required to move to resistance determination. The system is completely hands-free, and does away with sample preparation for Gram stains as well as for MALDI or other means of species ID, saving labs money while streamlining work-flow. With this technology it is perfectly possible to lower costs while improving patient care. Thanks in part to this grant the Spec80 80-bottle benchtop system will be available to customers well within the first half of 2017."
About the SpecID System
During growth in culture, bacteria produce small molecule volatile metabolites unique to their species and strain. Utilizing an inexpensive printed chemical sensor array to obtain a fingerprint that combines detection and identification into a simple, automated single step, the novel SpecID system identifies microorganism species and strain from a phenotypic metabolomic signature obtained during growth.
About Specific Technologies
Specific Technologies has developed in vitro diagnostic systems for rapid identification of cells at the strain level, and is applying this fundamental new platform to the detection and characterization of microorganisms during culture. The company's unique, patented metabolomic signature technology leverages a low-cost printed chemical colorimetric sensor array to identify cell type down to the strain level. Specific Technologies is located in Mountain View, CA.
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