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REAL TIME DETECTION OF BACTERIA IN PLATELET CONCENTRATES

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
60314
Program Year/Program:
2003 / SBIR
Agency Tracking Number:
HL070360
Solicitation Year:
N/A
Solicitation Topic Code:
N/A
Solicitation Number:
N/A
Small Business Information
BCR DIAGNOSTICS, INC.
1123 E. THUNDERHILL PL PHOENIX, AZ 85048-
View profile »
Woman-Owned: No
Minority-Owned: Yes
HUBZone-Owned: No
 
Phase 2
Fiscal Year: 2003
Title: REAL TIME DETECTION OF BACTERIA IN PLATELET CONCENTRATES
Agency: HHS
Contract: 2R44HL070360-02
Award Amount: $739,219.00
 

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.

Principal Investigator:

Boris Rotman
4018499957
ROTMAN@BCRBIOTECH.COM

Business Contact:

Rosario Guzman
4014232017
GUZMAN@BCRBIOTECH.COM
Small Business Information at Submission:

BCR DIAGNOSTICS
BCR DIAGNOSTICS 1062 EAST SHORE RD JAMESTOWN, RI 02835

EIN/Tax ID: 050416591
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No