The broader impact/commercial potential of this SBIR Phase I project to develop a portable chip-based diagnostic device to detect the biomarker troponin T in human blood for cardiac disease diagnosis. This nano-biosensor has the potential to improve patient outcomes and reduce healthcare costs. Many patients who experience chest pain, an early symptom of a heart attack (myocardial infarction, MI), are first seen by EMS (emergency medical services) and are transported to a hospital in an ambulance. EMS are equipped with electrocardiogram (EKG) devices, but approximately 40% of all heart attacks cannot be diagnosed with an EKG alone. This leads to longer wait times for a definitive diagnosis, causes difficulty for patient transport decisions, delays treatment for those experiencing a true MI, and causes unnecessary hospital admissions for patients who are later found not to have had a heart attack. Blood-based biomarker assays, which are currently not performed in a prehospital setting, are needed to reach a conclusive diagnosis for all heart attack types. A portable device to monitor troponin T in a prehospital setting would result in faster treatment via improved diagnosis, better routing of patients to appropriate medical centers, and a decrease in unnecessary hospital stays. The cardiac biomarker market, including troponin, is expected to grow to $9.9 billion by 2022. The innovation of the proposed technology lies in the metal nanostructures on the diagnostic chip. These nanostructures allow proteins to be delivered to the sensing area and detected in a high sensitivity manner, while excluding larger debris, such as blood cells. The proposed work will leverage optical techniques for real-time label-free detection of protein biomarkers at the nanostructured chip. The current method for manufacturing the detection chips is slow and uneconomical. This Phase I work will address the high-risk, high-reward technical challenges by creating a low-cost, high-throughput fabrication method to mass manufacture nanostructured chips with reproducible optical properties. Additionally, this Phase I work seeks to validate blood sample delivery to the sensing area and troponin T detection in blood using an integrated microfluidic device. The selectivity and specificity requirements will be addressed by attachment of custom DNA molecules to the sensing area. These pieces of DNA are designed to bind in a highly specific manner to troponin T only. The outcomes of this Phase I project will establish the scientific and technical foundations necessary to move into a Phase II project by developing a low cost and easy to use point-of-care device suitable for rapid prehospital diagnosis of heart attacks. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.
