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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: SB1AI094781
Amount: $998,515.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NIAID
Solicitation Number: PAR16-027
Timeline
Solicitation Year: 2017
Award Year: 2016
Award Start Date (Proposal Award Date): 2016-09-01
Award End Date (Contract End Date): 2019-08-31
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

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

The objectives of this Commercialization Readiness Pilot CRP Program proposal reflect the key
goals not supported by the Phase II or Phase IIB programs but required to achieve commercial
market entry of the SpecID blood culture system including development of blood culture media
manufacturing processes development of quality control and documentation systems FDA strategy to
achieve k approval and development of the SpecID blood culture instrument and blood culture
bottle sensor attachment 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 infection 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

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

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