Current treatment of cancer patients relies on establishing an accurate diagnosis using a complex combination of clinical and histopathological data but in some instances accurate diagnosis is difficult or impossible because of atypical clinical or histopathological data. The National Cancer Institute has called for accurate, practical, and affordable tools for the diagnosis of cancer in both research and clinical applications. The detection, identification, and evaluation of the expression pattern of a particular mRNA across many RNA samples are becoming a powerful technique for cancer diagnosis. Molecular assay of gene expression can offer systematic human cancer information useful to make clinical judgments regarding the disease and appropriate treatments. Measurement of tumor gene expression signatures will be done with a book-sized electro-analytical instrument and a disposable 96-sensor array element. The proposed expression analysis system will perform sensitive and selective gene probe assays linked to signal amplification via electroactive enzyme labels. The anticipated Phase I result will be establishing the feasibility of this technology by accomplishing the measurable milestones of validated measurements (greater than 90% agreement with real-time PCR), capable of probing expression signatures with highly sensitive DNA sensors (milestone 10x current sensitivity of 60,000 molecules) in Electrochemical Sensor Plate assays for multiple genes or multiple samples that take less than 2 hours. Alderon Biosciences, Inc. is an innovator in the rapidly developing field of molecular detection systems and the company maintains a chemistry, biochemistry, cell culture, and engineering staff experienced with electrochemical instruments and biologically modified sensors. The company has successfully raised several million dollars in non-SBIR funding for product development, regulatory approval, and commercialization. These experiences have yielded several products including an FDA-approved in vitro-diagnostic device designed to screen children for lead poisoning.
