Development of a disposable non-instrumented prothrombin time (PT) test for home use is proposed. Phase I data using flow channels built with precision woven fabric demonstrated the potential of the proposed test device. The blood flow endpoints formed due to clotting were repeatable, easy to read, and showed good correlation between PT and bar length. A simple and accurate disposable device is potentially a powerful tool to help patients monitor their PT at home. The specific objectives of this research are to: 1) finalize the design of the scale-up prototype device, 2) develop protocols to obtain scale-up and pilot production devices, 3) conduct clinical trials to evaluate the quality of the devices, and 4) submit data for FDA market approval.

Proposed Commercial Applications

NOT AVAILABLE

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 #
5R44HL067001-03
Application #
6622213
Study Section
Special Emphasis Panel (ZRG1-HEM-1 (10))
Program Officer
Link, Rebecca P
Project Start
2000-09-05
Project End
2005-01-31
Budget Start
2003-02-01
Budget End
2005-01-31
Support Year
3
Fiscal Year
2003
Total Cost
$338,441
Indirect Cost
Name
Portascience, Inc.
Department
Type
DUNS #
009762050
City
Moorestown
State
NJ
Country
United States
Zip Code
08057