APTITUDE MEDICAL SYSTEMS INC — Department of Health and Human Services SBIR Phase I: NHLBI

Description

PROJECT ABSTRACT There is a major need for the widespread measurement of cardiac troponin at high sensitivity in the diagnosis of myocardial infarction Yearly M patients present to the emergency department with symptoms of acute myocardial infarction Rapid identification can significantly improve patient outcomes and by ruling out those without myocardial infarction it can save hospitals billions of dollars per year High sensitivity cardiac troponin has become an accepted practice but it is limited to hospitals with sophisticated centrals labs There is no point of care version of this test which is urgently needed in pre hospital settings and in hospitals without a central lab We propose to develop a novel aptamer based POC troponin assay that utilizes high performance aptamers instead of antibodies in a simple and robust low cost microfluidic device to achieve detection limit of less than pg ml in min from blood In phase I we will develop a DNA aptamer pair with ultra high affinity and specificity against cTnI reduced non specific binding resistance to heterophilic antibody interference and increased stability and batch to batch consistency We will exploit these aptamers in an electrochemical microfluidic device with the capture aptamer immobilized on the sensor electrode and the detection aptamer forming a DNA concatemer yielding rapid kinetics and ultra high sensitivity and verified the technical feasibility with clinical samples In phase II we will create a prototype similar to a glucose test strip which outperforms the current standard point of care systems validated by a retrospective clinical study in healthy and AMI patients in comparison with commercial products We expect to follow on with private capital or strategic investment from a partner company to proceed through clinical stage and FDA clearance via collaboration with industry partners NARRATIVE Each year million patients present to the emergency department with symptoms of myocardial infarction requiring immediate diagnosis to improve chances for survival and save hospitals billions of dollars in unnecessary overcrowding New high sensitivity troponin I tests can enable such rapid diagnosis but they are limited to central labs and require over an hour of processing time We propose to create the first high sensitivity point of care troponin I assay that will enable the most immediate diagnosis in pre hospital settings and in hospitals which do not have sophisticated central labs