Rapid, Inexpensive Microchip Assay for Homocysteine

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 2R44HL083579-02A1
Agency Tracking Number: HL083579
Amount: $750,000.00
Phase: Phase II
Program: SBIR
Awards Year: 2008
Solicitation Year: 2008
Solicitation Topic Code: N/A
Solicitation Number: PHS2007-2
Small Business Information
DUNS: 141630561
HUBZone Owned: Y
Woman Owned: Y
Socially and Economically Disadvantaged: Y
Principal Investigator
 () -
Business Contact
Phone: (970) 491-4064
Research Institution
DESCRIPTION (provided by applicant): 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 consi dered 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 colalami n (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 gar nered 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 releva nt 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.

* Information listed above is at the time of submission. *

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