Sepsis is the leading cause of deaths in US hospitals contributing to or causing 52% of all US hospital deaths and is the most expensive condition treated in US hospitals, costing more than $17 billion annually. More than 300 million blood culture bottles are produced annually, with a market size greater than $1.2B in the US and EU alone. The two-year phase II period spanned February 2013 to February 2015 (5 R44 AI094781-03). The developments, funded in part by this grant, have created a new paradigm to diagnose blood stream infection causing sepsis. The work of this grant has assisted in creating the SpecID blood culture system, which the company is now commercializing. The SpecID solution replaces the present 3-step process for characterization of blood samples, currently divided into 1) detection of infection; 2) an obligatory Gram stain for all positive cultures performed on the bench by trained technician; and then 3) species ID by MALDI-TOF, (again requiring skilled sample preparation), The SpecID solution combines faster detection, more accurate Gram status determination than the benchtop stain, and ID more accurate than MALDI, in a single fully automated step which reduces the time to ID, streamlines lab workflow, and saves significant cost. The result is improved patient outcomes and improved lab operating performance. Phase IIB aims address application to clinical human specimens along with development of instruments and media appropriate for commercial use. The objectives of this proposal reflect the major goals required to achieve commercial entry of the SpecID smart culture system into commercial, high volume laboratories including development of the SpecID blood culture instrument, blood culture bottle sensor attachment, and the clinical and analytical studies to prove performance, gain regulatory approval and make first sales.

Public Health Relevance

Sepsis is the leading cause of deaths in US hospitals contributing to or causing 52% of all US hospital deaths and is the most expensive condition treated in US hospitals costing for than $17 billion annually. Rapid identification of the infectio is critical for effective treatment. The ultimate goal of this project is to bring hospitals a new technology solution that reduces the time to identification in a single automated instrument. The result is improved patient outcomes and importantly in today's cost critical healthcare system the solution is less expensive than current practice.

National Institute of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
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Special Emphasis Panel (ZRG1)
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Ritchie, Alec
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Isense, LLC
West Palm Beach
United States
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Lim, Sung H; Mix, Samantha; Anikst, Victoria et al. (2016) Bacterial culture detection and identification in blood agar plates with an optoelectronic nose. Analyst 141:918-25
Lim, Sung H; Mix, Samantha; Xu, Zeyu et al. (2014) Colorimetric sensor array allows fast detection and simultaneous identification of sepsis-causing bacteria in spiked blood culture. J Clin Microbiol 52:592-8