Programmable nano-bio-chips: multifunctional clinical tools for use at the point-of-care.

A new generation of programmable diagnostic devices is needed to take advantage of information generated from the study of genomics, proteomics, metabolomics and glycomics. This report describes the 'programmable nano-bio-chip' with potential to bridge the significant scientific, technology and clinical gaps through the creation of a diagnostic platform to measure the molecules of life. This approach, with results at the point-of-care, possesses capabilities for measuring such diverse analyte classes as cells, proteins, DNA and small molecules in the same compact device. Applications such as disease diagnosis and prognosis for areas including cancer, heart disease and HIV are described. New diagnostic panels are inserted as 'plug and play' elements into the modular platform with universal assay operating systems and standard read out sequences. The nano-bio-chip ensemble exhibits excellent analytical performance and cost-effectiveness with extensive validation versus standard reference methods (R(2) = 0.95-0.99). This report describes the construction and use of two major classes of nano-bio-chip designs that serve as cellular and chemical processing units, and provides perspective on future growth in this newly emerging field of programmable nano-bio-chip sensor systems.