Regulations governing clinical laboratory testing and good laboratory practice require each patient test be accompanied by quality controls. Controls for current nucleic acid testing usually consist of reused patient specimens that are unstable and may be infectious. This Phase I project develops a system to produce synthetic controls and standards for molecular based diagnostic testing. Unique product features are the following: the release of nucleic acid in the clinical test, non-infectivity, and stability for months at room temperature and 4 C. The synthetic controls are cationic liposome-encapsulated oligonucleotides produced using modified liposomal gene therapy techniques. For this feasibility study, the prototype product will be a BCR/abl based RNA segment complexed with a cationic liposome. Reproducible results obtained during several days of routine laboratory use of the control material will demonstrate success. Unique process features are the following: ease of preparation, applicability to RNA and DNA, and the ability to encompass oligonucleotides up to 19 kb in size. The result of this work will be a low cost method for the production of stable and easy to produce encapsulated RNA and DNA oligonucleotides. A family of controls and standards including quantitative RNA standards will be developed in Phase II.
The technology developed in this Phase I project will be used to produce quality control products for BCR/abl laboratory tests. Targeted customers will be all diagnostic laboratories testing for the BCR/abl gene rearrangement associated with chronic myelogenous leukemia (CML) and manufacturers of CML diagnostic kits.
