Tasso, Inc — Department of Health and Human Services SBIR Phase I: NIAID

Description

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 the rudimentary level of sample preparation they accomplish and the use of blood collection methods that limit the volumes of blood that are utilized and induce high levels of error Based on 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 the collaboration with Prof David Beebe an essential thought leaders in the field of clinical microfluidics and sample preparation technologies 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 uL These engineering developments will set the stage for aim in which we will perform a pilot clinical study on two cohorts of human volunteers We will select serum proteins with high abundance and measure these in the first cohort and repeat the process on 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 Project Narrative 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 cost diagnostic information critical to patient management