DEVELOPMENT OF LIPOSOME COMPLEXED RNA QUALITY CONTROLS

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$738,399.00
Award Year:
2002
Program:
SBIR
Phase:
Phase II
Contract:
2R44GM062085-02
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.
MAINE MOLECULAR QUALITY CONTROLS, 81 RESEARCH DR, SCARBOROUGH, ME, 04074
Hubzone Owned:
N
Socially and Economically Disadvantaged:
N
Woman Owned:
N
Duns:
n/a
Principal Investigator:
CLARK RUNDELL
(207) 885-2733
RUNDELL@MMQCI.COM
Business Contact:
JOAN GORDON
(207) 885-8115
JGORDON@MMQCI.COM
Research Institution:
n/a
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.

* information listed above is at the time of submission.

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