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Beacon Biotechnology's Point of Care Type I Diabetes Screen

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
96059
Program Year/Program:
2010 / SBIR
Agency Tracking Number:
DK088490
Solicitation Year:
N/A
Solicitation Topic Code:
NIDDK
Solicitation Number:
N/A
Small Business Information
BEACON BIOTECHNOLOGY, LLC
12635 E. MONTVIEW BLVD. AURORA, CO 80045
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 1
Fiscal Year: 2010
Title: Beacon Biotechnology's Point of Care Type I Diabetes Screen
Agency: HHS
Contract: 1R43DK088490-01
Award Amount: $329,529.00
 

Abstract:

* * Description of team not provided in the application aside from CVs thus making it difficult to assess quality. 3. Innovation: Strengths * Development of inexpensive, simple, disposable, point-of-care screening method attractive. * A ntigen-modified detector is unique. * Solid IP concerning bioluminescent molecules attached to the surface of a detector. Weaknesses * Clear description why ELISA has not proven successful for diabetes-related autoantibody testing lacking. * Pr oposal ignores other bioluminescence immunoassay products on the market. * What is envisioned cost per device? Instrument development not a part of the proposal. 4. Approach: Strengths * Detailed description of protein preparation (e.g., p reparation of biotinylated proteins, etc.) and use methodology comparing two methods for quantifying the relevant antibodies. * Alternative approaches proposed to counter potential pitfalls and if sensitivity or selectivity criteria are not met (i.e., e quivalent to current FDA approved methods). Weaknesses * Research and design merely compares two techniques that employ the BrightSPOT platform. Instrumentation neither described nor made clear if already complete. * Preliminary data based predomi nately on HIV application in pooled plasma. Where blood is used, it is first diluted. How this influences speed, limit of detection and sensitivity not clear. * Stability/shelf-life of immobilized antigen not addressed. 5. Environment: Strengt hs * Company seems to have adequate space, equipment, and resources. * Team will also take advantage of resources at the University of Colorado-Denver. Weaknesses * None Protections for Human Subjects: Not Applicable (No Human Subjects) Vertebrate Animals: Not Applicable (No Vertebrate Animals) Biohazards: Acceptable Budget and Period of Support: Recommended budget modifications or possible overlap identified: * No real evidence of need for additional 6 months (12 totals) of funding. * Budget too high for proposed work. Salary for individuals conducting work unrelated to proposal requested (e.g., FDA consultant, software development, etc.) but not warranted. Resource Sharing Plans: Not Applicabl e (No Relevant Resources)

Principal Investigator:

Christina L. Roark
CROARK@BEACONBIOTECHNOLOGY.COM

Business Contact:

Christina L. Roark
llansing@beaconbiotechnology.com
Small Business Information at Submission:

BEACON BIOTECHNOLOGY, LLC
BEACON BIOTECHNOLOGY, LLC 12635 E. MONTVIEW BLVD. AURORA, CO 80045

EIN/Tax ID: 120581643
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No