Research Project
9047035
? DESCRIPTION (provided by applicant): There is an urgent unmet need for diagnostic technologies that can rapidly inform a healthcare professional on the appropriate management strategy for patients with infectious diseases. Recent epidemics of flu and Ebola have crucially highlighted the importance for rapid detection solutions. However, point-of-care (POC) diagnostic devices are currently limited to a narrow range of abundant biomarkers principally due to (1) the rudimentary level of sample preparation they accomplish, and (2) the use of blood collection methods that limit the volumes of blood that are utilized and induce high levels of error. Based on 2 technologies developed by Tasso, Inc. and by researchers at the University of Wisconsin - Madison, we propose the development of an integrated sample collection - to - preparation platform, the HemoLink-SPOT, which will allow performing immunoassays on par with laboratory assays in a point-of-care setting. The resulting platform will enable measuring a broad range of proteins, including low abundance viral antigens and host response proteins, using a handheld device. Ultimately, we expect this technology will open new windows of diagnostic closer to time of infection, leading to the ability to perform important patient management decisions earlier. To achieve this project, Tasso is uniquely positioned through (1) the collaboration with Prof. David Beebe, an essential thought leaders in the field of clinical microfluidics and sample preparation technologies, (2) on-going IRB-approved clinical trials for the blood collection platform, the HemoLink, which will enable testing the technology proposed in the Phase I project. These basis will ensure the development of a technology that is broadly applicable and that works on real-world, clinically-relevant, sample matrices. The proposal consists of three Aims. First, a manufacturable embodiment of the HemoLink-SPOT sample preparation cartridge will be designed, optimized, and tested for its ability to purify from whole blood proteins of interest and perform all the steps required for an ELISA. Secondly, the HemoLink blood-collection platform will be modified to interface with the sample preparation cartridge allowing the simple user-friendly transfer of a precise volume of blood of 150 uL. These 2 engineering developments will set the stage for aim 3, in which we will perform a pilot clinical study on two cohorts of 15 human volunteers. We will select 2 serum proteins with high abundance and measure these in the first cohort and repeat the process on 2 selected serum proteins of low-abundance in the second cohort. These studies will provide important technological risk-assessment towards a Phase II application. PUBLIC HEALTH RELEV: Current POC solutions for infectious diseases suffer from a very limited sensitivity and range of tests that can be performed. These usually require that the disease is sufficiently advanced to measure host antibodies. Tasso,Inc. is proposing the development of a system that will allow laboratory-quality test to the point-of-care thus opening new diagnostic windows at earlier time points in the disease progression. The device will provide patients at home, or medical staff in outpatient clinics, with early, sensitive, and low-cot diagnostic information critical to patient management.
