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DEVELOPMENT OF LIPOSOME COMPLEXED RNA QUALITY CONTROLS

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
61036
Program Year/Program:
2002 / SBIR
Agency Tracking Number:
GM062085
Solicitation Year:
N/A
Solicitation Topic Code:
N/A
Solicitation Number:
N/A
Small Business Information
MAINE MOLECULAR QUALITY CONTROLS, INC.
10 SOUTHGATE ROAD SUITE 170 SCARBOROUGH, ME 04074
View profile »
Woman-Owned: Yes
Minority-Owned: No
HUBZone-Owned: No
 
Phase 2
Fiscal Year: 2002
Title: DEVELOPMENT OF LIPOSOME COMPLEXED RNA QUALITY CONTROLS
Agency: HHS
Contract: 2R44GM062085-02
Award Amount: $738,399.00
 

Abstract:

DESCRIPTION (provided by applicant): The explosion of new molecular laboratory tests has significantly improved diagnosis and management of leukemia, but the problem of a renewable supply of stable controls for test validation has not been resolved. The current paradigm of using cell lines or patient specimens for quality assurance is unsatisfactory because materials are unstable, potentially infectious, of limited supply, and cannot be processed through routine test extractions. Patient confidentiality is problematic and each specimen has only one genotype, thus making control of multiplex tests, including gene chips, prohibitively expensive. Phase II will produce synthetic, stable, non-infectious, multi-analyte controls for quality assurance of molecular-based leukemia tests. Feasibility of our novel approach was demonstrated by Phase I production of stable, cationic liposome-complexed RNA, useful as controls in BCR-ABL clinical tests. Phase II manufacture of a comprehensive Leukemia Control Set begins by creating seven additional clone banks containing leukemic gene segments. RNA will be produced in vitro and stabilized with liposome complexes generated by Phase I proprietary techniques. Reference gene segments will be incorporated to render controls useful for minimal residual disease quantification tests used to direct therapies. The proposed project makes a significant contribution to the support and implementation of critical molecular tests for leukemia.

Principal Investigator:

Clark A. Rundell
2078852733
RUNDELL@MMQCI.COM

Business Contact:

Joan Gordon
2078858115
JGORDON@MMQCI.COM
Small Business Information at Submission:

MAINE MOLECULAR QUALITY CONTROLS, INC.
MAINE MOLECULAR QUALITY CONTROLS 81 RESEARCH DR SCARBOROUGH, ME 04074

EIN/Tax ID: 010532331
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No