title: Point-of-care molecular diagnostic devices: an overview.
abstract: Point-of-care molecular diagnostic devices are a rapidly expanding market. A variety of technologies are being developed for DNA detection and amplification, mostly aiming to detect pathogens. Of the two devices for detection of human genetic variations, both focus on CYP2C19 and have obtained regulatory approval. Most other devices have not obtained US FDA approval and are still undergoing clinical trials. Most, if not all, devices in development require equipment to which disposable test cartridges are placed. Thus, they may not fulfill FDA's definition of being 'simple'. There is a clear need to develop completely disposable devices that do not require equipment maintenance, and to detect other genetic variants predictive of disease susceptibility and drug response.
authors.affiliation: Department of Medicine, Royal Melbourne Hospital, The University of Melbourne, Parkville, VIC 3050, Australia.
authors.forename: Chi Lan Nguyen
authors.initials: CL
authors.lastname: Vu
authors.affiliation: Department of Medicine, Royal Melbourne Hospital, The University of Melbourne, Parkville, VIC 3050, Australia.
authors.forename: Jianxiong
authors.initials: J
authors.lastname: Chan
authors.affiliation: Department of Medicine, Royal Melbourne Hospital, The University of Melbourne, Parkville, VIC 3050, Australia.|Department of Neurology, Royal Melbourne Hospital, Parkville, VIC 3050, Australia.
authors.forename: Marian
authors.initials: M
authors.lastname: Todaro
authors.affiliation: Centre for Neural Engineering, The University of Melbourne, Parkville, VIC 3050, Australia.
authors.forename: Stan
authors.initials: S
authors.lastname: Skafidas
authors.affiliation: Department of Medicine, Royal Melbourne Hospital, The University of Melbourne, Parkville, VIC 3050, Australia.|Department of Neurology, Royal Melbourne Hospital, Parkville, VIC 3050, Australia.
authors.forename: Patrick
authors.initials: P
authors.lastname: Kwan
mesh_terms: D065731:Cytochrome P-450 CYP2C19 / Q000235:genetics; D004247:DNA / Q000235:genetics; D014644:Genetic Variation / Q000235:genetics; D006801:Humans; D025202:Molecular Diagnostic Techniques / Q000295:instrumentation* / Q000379:methods; D057089:Pathology, Molecular / Q000295:instrumentation; D019095:Point-of-Care Systems; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D004247:DNA; C045793:CYP2C19 protein, human; D065731:Cytochrome P-450 CYP2C19
keywords: Atlas io™; Gene Z; Nanomix; Nanosphere Verigene®; QuantuMDx Q-POC™; SNP Dr; Spartan; molecular diagnosis; point-of-care