SBIR-STTR Award

Cardiovascular disease is the number 1 killer in the United States and much of the Western world. Treatment of the disease costs billions of dollars each year and the costs continue to rise exponentially. Many strides have been made toward improving behavioral patterns that put people at risk, however there is still a need to develop methods to detect disease onset at the earliest possible stage. Early detection requires the measurement of a clinically relevant disease biomarker. One such marker that can be measured is homocysteine. Homocyteine is an amino acid involved in the biosynthesis methionine and has been clinically linked to cardiovascular disease in a number of studies. Existing methods for measurement of homocysteine require expensive instrumentation, are time consuming, and can only be performed in a clinical laboratory. Advanced Microlabs, LLC is developing microfluidic technology for rapid detection of disease biomarkers that will be inexpensive ($1000 instrument, $5/assay) and require very small samples (1-5 microliters). In the current project, we propose to develop an assay for homocysteine starting from whole blood samples. Our technology platform couples electrochemical detection to microchip electrophoresis to provide the desired low-cost, high portability characteristics. During this project, we wiill develop an assay for both total homocysteine and protein-bound homocysteine using this technology. In addition, we will also develop a second microfluidic device that will allow us to isolate cells from whole blood, a requirement for making accurate measurements. The result of this project will be new techology for the measurement of homocysteine as well as continuous generation of cell free media for analysis.

Cardiovascular disease (CVD) is the number 1 killer in the United States and much of the Western world. Treatment of the disease costs billions of dollars each year and the costs continue to rise exponentially. If considered as a separate condition outside of CVD, stroke is the 3rd leading cause of death behind heart disease and cancer. Total Homocysteine (tHCY) is a confirmed independent risk factor for CVD. Additionally, it is a sensitive marker for folate and colalamin (vitamin B12) deficiency, with implications to birth defects, pregnancy complications, psychiatric disorders, and cognitive impairment in the elderly. Several million tHCY tests are performed annually in the U.S. related to these conditions. tHCY has garnered significant attention as a modifiable risk factor for CVD because levels can be reduced simply through dietary supplementation of Folic Acid and Vitamin B12. While tHCY's value in this manner still remains unconfirmed, strong evidence is mounting in its association specifically with stroke. At the same time, tHCY is finding a growing market as a vitamin deficiency monitoring tool for patients taking drugs known to degrade folate metabolism. An additional marker, Reduced Homocysteine (reHCY), has also been proposed as an alternative to tHCY. Currently, tHCY and reHCY analysis requires expensive instrumentation, time consuming procedures, and can only be performed in a clinical laboratory. Advanced Microlabs, LLC is developing microfluidic technology for rapid detection of disease biomarkers that will be inexpensive ($500 instrument, $3/assay), require very small samples (i.e., finger prick instead of a blood draw), provide results within minutes, and require no sample pretreatment such as centrifugation as is now currently the case. In the current project, we will build on our successful Phase I results and create a versatile point-of-care device for the detection of tHCY and reHCY. Additionally because our device is a multi-analyte platform, other relevant markers could be added to our menu in Phase III.

Public Health Relevance:
The U.S. POC market became a $10 billion industry in 2005 and is currently growing at a faster rate than central laboratory testing. This is because devices like ours offer cheaper testing, closer to the patient, reduction in healthcare costs, and enhancements the physician-patient dialog and thus improving care.

Public Health Relevance:
This Public Health Relevance is not available.

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