Value Proposition: Traditional DNA integrity testing relies on real time PCR to amplify a limited number of chromosomal loci and determine the relative proportions of segments. This suffers from biased amplification that will skew the distribution of DNA lengths and make accurate determination of concentrations difficult. In addition, PCR based methods are cost prohibitive in clinical environments since they require expensive reagents, are laborious to perform, and require specialized equipment. Cylindrical Illumination Confocal Spectroscopy (CICS), an implementation of single molecule confocal fluorescence spectroscopy, eliminates the need to utilize RT-PCR for amplification while allowing to determine DNA size and quantity in a highly efficient and accurate manner through fluorescence burst size distribution analysis (BSDA).
Technical Details: The DNA Integrity Assay (DIA) analyzes the size distribution of cell free DNA to determine disease state. Apoptotic cells release DNA fragments of small, uniform size due to the controlled molecular processes that occur upon cell death. Yet, in tumor cells where apoptosis is inhibited, cell death often occurs through necrosis, which releases DNA of large and variable size. Thus, the size distribution of cell free DNA can be used as a nonspecific marker of neoplastic disease. Because cell free DNA can be readily and non-invasively obtained through urine, stool, or blood samples, DIA has high potential for routine cancer screening and treatment monitoring. BSDA correlates fluorescent burst size to DNA length through the stoichiometric labeling and analysis of individual DNA fragments. This new method of performing DIA increases assay specificity, sensitivity, and speed while lowering cost.
Patent Status: Granted US Patent 8,835,110
Associated Technologies: C10398
