REAL TIME DETECTION OF BACTERIA IN PLATELET CONCENTRATES

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$739,219.00
Award Year:
2003
Program:
SBIR
Phase:
Phase II
Contract:
2R44HL070360-02
Award Id:
60314
Agency Tracking Number:
HL070360
Solicitation Year:
n/a
Solicitation Topic Code:
n/a
Solicitation Number:
n/a
Small Business Information
BCR DIAGNOSTICS, 1062 EAST SHORE RD, JAMESTOWN, RI, 02835
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
n/a
Principal Investigator:
BORIS ROTMAN
(401) 849-9957
ROTMAN@BCRBIOTECH.COM
Business Contact:
ROSARIO GUZMAN
(401) 423-2017
GUZMAN@BCRBIOTECH.COM
Research Institute:
n/a
Abstract
DESCRIPTION (provided by applicant): Bacterial contamination of blood products is currently a major problem in transfusion medicine and a leading cause of transfusion-related deaths. Platelets are particularly susceptible to contamination because they are stored at room temperature. BCR Diagnostics, Inc. (BCR) has developed a novel biosensor platform for detecting low levels of bacteria in real time (i.e., about 2 minutes). During Phase I, BCR has demonstrated the feasibility of adapting its technology to developing a low-cost biosensor for detecting bacteria in platelet concentrates shortly before transfusions. BCR's biosensor is based on the LEXSAS (Label-free Exponential Signal-Amplification System), a unique methodology using spores as ultrasensitive nanodetectors capable of emitting fluorescent light signals when encountering single bacterial cells. For Phase II, BCR proposes: 1. To construct a marketable biosensor prototype that will extend the system's sensitivity to single bacterial cells. 2. To use the prototype for a study designed to obtain experimental data that will meet the Food and Drug Administration (FDA) requirements for premarket approval of the biosensor. The study will consist of three major tasks: 1. To test, optimize, and standardize the biosensor prototype in terms of sensitivity, completion time, analysis reproducibility, and dynamic range. 2. To use the prototype for experiments designed to obtain a "Data Package" to be submitted to the FDA. This task includes experiments that will show the accuracy (sensitivity and specificity) of the biosensor for identifying platelet concentrates spiked with a panel of about 13 different bacterial strains from a list provided by the FDA. 3. To do a double-blind study to validate the commercial usefulness of the biosensor. Other potential applications of the bacteriologic biosensor include: diagnostics, environmental surveillance, food and beverage monitoring, and sterility testing.

* information listed above is at the time of submission.

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