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Rapid Identification of Pathogenic Bacteria in Blood causing Sepsis

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2SB1AI094781-04
Agency Tracking Number: R44AI094781
Amount: $1,653,515.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NIAID
Solicitation Number: PA15-269
Timeline
Solicitation Year: 2016
Award Year: 2016
Award Start Date (Proposal Award Date): 2016-09-01
Award End Date (Contract End Date): 2016-08-31
Small Business Information
500 S AUSTRALIAN AVE
West Palm Beach, FL 33401-6223
United States
DUNS: 827877486
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 RAY MARTINO
 (650) 938-6200
 rmartino@isensesystems.com
Business Contact
 PAUL RHODES
Phone: (650) 938-6200
Email: prhodes@isensesystems.com
Research Institution
N/A
Abstract

DESCRIPTION provided by applicant Sepsis is the leading cause of deaths in US hospitals contributing to or causing of all US hospital deaths and is the most expensive condition treated in US hospitals costing more than $ billion annually More than million blood culture bottles are produced annually with a market size greater than $ B in the US and EU alone The two year phase II period spanned February to February R AI 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 step process for characterization of blood samples currently divided into detection of infection an obligatory Gram stain for all positive cultures performed on the bench by trained technician and then 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 of all US hospital deaths and is the most expensive condition treated in US hospitals costing for than $ 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 todayandapos s cost critical healthcare system the solution is less expensive than current practice

* Information listed above is at the time of submission. *

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