Acute myocardial infarction (MI), aka "heart attack" is the biggest killer in the western world and is the cause of death for nearly 500,000 Americans each year. The symptoms of MI can be vague and non-specific;for this reason 6 to 9 million adults present to hospital Emergency Departments in the US and are worked up for suspected MI annually. Advances in cardiac biomarkers have had a large impact on the diagnosis, risk stratification and management of suspected MI patients and rapid and sensitive testing of the cardiac biomarkers troponin has become the cornerstone for diagnostic workup and care of suspected MI patients. Rapid troponin testing can decrease time to appropriate treatment for MI patients and allow for faster MI rule-out, which will help decrease the $10 to $13 billion expended annually for the care of non-MI patients in coronary care units. Yet, despite the clear need for sensitive and rapid cardiac troponin measurements to quickly diagnose and manage patients, there is no POC system that can match the analytical performance of contemporary sensitive laboratory systems. In this project we will produce and demonstrate a fully integrated POC immunoassay platform, based on a CMOS microchip, that is as easy to use as an over the counter pregnancy test and as accurate as state-of- the-art laboratory tests (15pg/mL with 10% CV). In addition to troponin, which is critically important, the system is capable of measuring a myriad of other biomarkers for heart failure, pulmonary embolism and deep vein thrombosis, sepsis and other conditions where speed, convenience and in the field measurement of biomarkers is important.

Public Health Relevance

The lack of laboratory quality point-of-care (POC) tests, forces healthcare providers to implement inefficient testing protocols and make decisions based on incomplete information. This effects patient outcomes and causes the healthcare system to spend billions of dollars each year on unnecessary treatments. In this project we demonstrate a microchip-based assay platform that performs assays with laboratory precision and a one-step protocol and which can be mass- produced in existing microchip foundries.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
2R44HL116078-02
Application #
8648513
Study Section
Special Emphasis Panel (ZRG1-CVRS-C (10))
Program Officer
Lee, Albert
Project Start
2012-08-15
Project End
2015-01-31
Budget Start
2014-02-15
Budget End
2015-01-31
Support Year
2
Fiscal Year
2014
Total Cost
$1,886,700
Indirect Cost
Name
Silicon Biodevices, Inc.
Department
Type
DUNS #
830821927
City
Palo Alto
State
CA
Country
United States
Zip Code
94303