Semiconductor Electronic Label-Free Assay (SELFA) for Diagnosing Heart Disease

DESCRIPTION provided by applicant Cardiovascular disease is the leading cause of morbidity and mortality worldwide In United States and Europe alone about million patients are annually admitted to emergency departments with acute coronary syndrome These patients are immediately screened for potential acute myocardial infarction AMI via electrocardiogram and biomarker detection in blood samples Due to its high specificity and elevated concentrations in blood for hours past an incident cardiac troponin I cTnI has become one of the most reliable biomarkers for diagnosing AMI where a cTnI concentration of less than ng mL is considered a negative result while a cTnI concentration of ng mL or greater is considered a positive result Furthermore recent studies have shown that cTnI could also be used for AMI risk stratification However for this intended use ultra sensitive assays are required to detect slightly elevated levels of cTnI in blood samples Currently there are two methods available for determining the concentration of cTnI in patient samples lab based assays and point of care POC assays While lab based assays are more sensitive they have a longer turnaround time TAT of typically minutes to hour which is not ideal for application such as diagnosing AMI where speed is crucial On the other hand while current POC assays have much improved TAT of minutes and could be implemented at bed side they have inferior sensitivity and hence found to not be as reliable as lab based assays Additionally even the current lab based assays do not have the necessary analytical sensitivity in quantifying cTnI in patient samples to aid in AMI risk stratification We at Selfa Inc aim to develop a novel and sensitive label free POC assay for rapid reliable and accurate detection of cTnI in patient blood samples that could aid in diagnosing and risk stratification of AMI This assay will be based on a novel semiconductor nanowire field effect transistor technology that utilizes anti cTnI antibodies to quantify cTnI in a patient sample In or preliminary studies we have demonstrated a fold improved sensitivity in detecting cTnI concentrations compared to current lab based assays Our novel assay will consist of disposable one time use test strips and an easy to use and portable reader In Phase I of this Fast Track proposal we will a examine various anti cTnI antibody cTnI combinations to maximize the sensitivity of our biosensor and b develop and optimize the th generation lab grade SELFA test strips prototype and validate their analytical and clinical performance Upon successful completion of Phase I in Phase II of this proposal we will c develop and optimize the st generation commercial grade SELFA test strips and portable reader device d establish and evaluate a robust strategy for high throughput calibration of the test strips and finally f validate the analytical and clinical performance of the commercial grade test strips an reader and prepare and initial the FDA regulatory approval process PUBLIC HEALTH RELEVANCE The aim of this project is to develop a novel and sensitive point of care assay for rapid reliable and accurate detection of cardiac troponin I in patient blood samples that could aid doctors in diagnosing and risk stratification of acute myocardial infarction