Virogenomics is currently developing a portable, electrochemical device for rapid disease diagnosis of multiple indications. The basis of our approach is a patent-pending electrochemical immunoassay performed on patterned electrode arrays, and we take advantage of existing microelectronics technology to create this sensor platform. Importantly, we fabricate our sensors using an attachment method that is broadly reactive, and therefore will allow us to incorporate new ligands onto the device as new biomarker-ligand pairs are discovered. This is accomplished using surfaces that are resistant to non-specific adsorption, enabling the platform to work with complex samples such as serum. The envisioned product will present 6-20+ unique sensors arrayed onto a single support, and will be integrated with fluid handling technologies into a device equipped with hardware and firmware required to do a complete analysis of biomarkers in serum samples and communicate the result. External readers, such as a fluorescent microscope, are not used, enabling a standalone device. The target materials and manufacturing cost for the assay cartridges is $15-50. The target reader instrument cost is $500-1000. The combination of quantitative electrochemical detection with rapid, low-cost diagnosis from multiple biomarkers in a single serum sample will provide a significant improvement to existing technologies. The proposed grant project aims to collaborate closely with the Oregon Health and Science University (OHSU) to establish the feasibility of using the Virogenomics electrochemical assay for use in the multiplexed analysis of 4 serum antibodies linked to Rheumatoid arthritis in a single sample of serum. Using an IRB-approved protocol, we aim to collect serum samples from patients that are positive for RA. We aim to benchmark the performance of our assay against standard ELISA-based methods for the quantitative analysis of serum antibodies. No current array technology has this level of flexibility in design, fabrication and operation for completely electronic (non-optical) diagnostic test. This method is scalable in two dimensions: First, increasing the number of sensor pads in one device will allow for biomarker profiling on a single sample. Second, increasing the number of instrument ports will permit a larger number of human samples to be run at a given time. We aim to open up a new set of tools for use in research and FDA approved diagnostics.
Public Health Relevance: This Phase 1 NIH SBIR project proposes to rapidly assess the feasibility of using an electrochemical diagnostic and instrumentation system for the low-cost, multiplexed detection of serum autoantibodies linked to rheumatoid arthritis. If successful, this technology would be transformative in the clinical diagnosis of rheumatic, musculoskeletal and skin diseases. In addition, this multiplexed test uses a novel attachment chemistry that would be amenable to incorporating new ligands of diagnostic utility as they are discovered.
