Advances in the field of in vitro diagnostics (IVDs) have reduced the levels of hepatitis B & C in the blood supply. Quantitative, genome-based IVDs for-hepatitis are being developed using the polymerase chain reaction (PCR) technology. These lVDs are more sensitive than the currently employed IVDs, therefore, they have the potential to further reduce the levels of contaminated blood. In addition, quantitative IVDs are needed to monitor treatments and to develop new treatments for viral infections. The primary concerns among clinicians regarding the PCR technology are the high susceptibility to contaminating DNA and the lack of standardization. Both of these problems are inherent to the PCR technology, which involves amplifying a few DNA molecules to several million copies. The long term objective of this research is to develop quantitative, genomic-based IVDs for a range of infectious viruses and bacteria based on a proprietary technology which does not involve DNA amplification. The presence of viral DNA or RNA affects the release of a probe. The method has the potential to be more sensitive than PCR because release of a single probe can be detected. An automated version of the method will be developed in a 96 well format.
Based on the work completed in Phase I, it is our goal to develop and market a quantitative, in vitro diagnostic test for hepatitis B and to follow shortly with tests for hepatitis C, HIV, CMV and RSV. We also intend to develop tests for non-viral infectious organisms.
