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Abstract

Grant Number:	5R44GM062085-03
PI Name:	RUNDELL, CLARK A.
PI Email:	rundell@mmqci.com
PI Title:
Project Title:	Development of Liposome Complexed RNA Quality Controls

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.

Thesaurus Terms:
RNA, analytical method, diagnosis quality /standard, liposome, synthetic nucleic acid, technology /technique development
biomedical equipment development, microarray technology, molecular cloning, transfection
polymerase chain reaction

Institution:	MAINE MOLECULAR QUALITY CONTROLS, INC.
	81 RESEARCH DR
	SCARBOROUGH, ME 04074
Fiscal Year:	2003
Department:
Project Start:	01-SEP-2000
Project End:	31-AUG-2004
ICD:	NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES
IRG:	ZRG1

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