DxDiscovery begins most diagnostic development projects by identifying which proteins or other molecules indicate the presence of disease in the patient. These indicators are known as biomarkers. DxDiscovery then develops sensitive and specific detection reagents (monoclonal or polyclonal antibodies) that can pinpoint these biomarkers in patient samples, such as blood or urine.
Our primary approach to intellectual property is to capitalize on our biomarker discoveries by patenting the use of these biomarkers for diagnosis of their respective diseases. In cases where a disease already has a known, suitable, biomarker, the detection reagents themselves can be patented (antibody sequencing). In addition, DxDiscovery’s technologies for efficient biomarker discovery and detection reagent development are proprietary, and they enable us to establish an advantageous and protected commercial niche.
Initially, DxDiscovery will license the use of biomarkers and detection reagents, e.g., monoclonal antibodies, to partner firms for the manufacture and sale of diagnostic kits. Ultimately, DxDiscovery will develop internal manufacturing and marketing capabilities for select diagnostics that are the best fit for such in-house production.
DxDiscovery has a portfolio of diagnostic development projects. For each product in our pipeline, we pursue a mixture of funding sources to maximize research opportunities and minimize time to market delivery. Most early-stage projects are supported by federal small business innovation research (SBIR) grants or small business technology transfer (STTR) grants. For example, development of our diagnostic for invasive candidiasis is supported by a multi-year grant from the National Institute for Allergy and Infectious Diseases. We pursue strategic partnerships with private or corporate investors as diagnostic projects mature through Phase I feasibility and Phase II pre-clinical studies (federally funded) into Phase III clinical trials (privately funded).
DxDiscovery is well poised to take advantage of the exponential growth in the point-of-care diagnostics market. The in vitro diagnostics business sector had a $60 billion dollar global market in 2012 with an expected compound annual growth rate of 6.8% through 2018.
DxDiscovery develops strategic partnerships with investors for products that are nearing clinical trials. For interested private or corporate investors, we encourage early communication, ideally during the initiation of the pre-clinical studies phase of product development.