MOLECULAR DX: MEETING CLINICAL EXPECTATIONS

Thurai Moorthy

President/CEO MultiGEN Diagnostics, North Carolina, USA

Abstract

Since the elucidation of DNA structure, attempts have been made to use this novel nucleotide polymer for diagnostic purposes. In doing so, several technologies have been developed to enable the development of specific assays for clinical diagnosis, public health, food safety, veterinary, environment and biopharmaceuticals. Market acceptance of these assays is based on a combination of cost, user friendliness, and clinical performance. At the same time, a wealth of scientific knowledge is continually published, which brings new information about diseases and potential treatment modalities (e.g. targeted chemotherapy). Although most present assays are for confirming clinical symptoms (e.g. C. trachomatis and N. gonorrhea), the newclinical trend includes screening (e.g. colorectal cancer) and predicting (pharmacogenomics), public health (e.g. Zika virus), monitoring treatment efficacy (e.g. cell-free circulating DNA), and personalized medicine. Thus, clinical expectations are increasing the need for new molecular tools. To fulfill these new realities, we present four new molecular platforms (MultiGEN, IC-Code, PrimaCap, Allele Specific Multiplex Sequencing - ASMS), which within a short period can enable the development of the most appropriate assay to meet respective clinical expectations.