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TDI’s Isonostic™ products bring a new class of biomarkers (protein isoforms) into clinical use. Isonostic™ assays are able to quantify both the isoforms currently seen by molecular diagnostics and a much wider variety of protein post-translational modifications (PTMs). Molecular diagnostics (DNA and RNA) offer insights into single nucleotide polymorphisms (SNPs) and splice variants, which account for 8-10% of protein isoforms. Traditional immunodiagnostic assays (IAs) report the overall up- or down-regulation of the parent protein, typically lumping all isoforms of that protein into the result. Isonostic™ assays combine the power of immuodiagnostics with the isoform resolving power of capillary electrophoretic methods.
TDI’s core focus is the development of Isonostic™ assays that better direct clinical decisions in cancer treatment and monitoring. Cancer is tied with heart disease as the leading cause of death in the US.1,2 Current cancer diagnostic tests exhibit poor specificity (false positive rates) and sensitivity (false negative rates).1 More importantly, there are few clinical assays that can be used by the pathologist and oncologist to direct the course of therapy once a patient is diagnosed with cancer. Consequently, most tumors are aggressively treated, although the aggressive treatment may only benefit a small fraction of the patients. This paradigm of conservative over-treatment results in unnecessary hardships and side effects for large numbers of patients and adds a substantial and potentially avoidable cost burden on the US healthcare system.