Case Number 113053 - Paper-Based Anti-Coagulation Diagnostic
Contact: Michael Hansen
Description: Drs. Andrew Steckl of the College of Applied Science and Engineering and Giovanni Pauletti of the James L. Winkle College of Pharmacy have developed a paper-based diagnostic device for coagulation.
Over 33 million prescriptions are written in the U.S. each year for approximately 6 to 7 million patients for the leading oral anticoagulant, warfarin. To ensure adequate anticoagulation management, frequent monitoring of drug efficacy is crucial as overdosing can lead to internal bleeding, and underdosing may increase the risk of life-threatening blood clots. Portable Point-of-Care testing devices, in contrast to regular visits to an accredited laboratory or hospital, offer the advantage of convenient home monitoring. Led by the rising number of patients on anticoagulation regimens, improved reimbursement for POC supplies, and superior patient satisfaction for self-testing applications, POC products focusing on coagulation diagnostics are predicted to experience continued strong demand in the near future. To successfully perform meaningful diagnostic self-testing, patients must have reasonable visual acuity, manual dexterity, and cognitive ability. These requirements are met by about 50-60% of patients currently receiving oral anticoagulants. Therefore, we conservatively estimate a U.S. market size of 3 million patients for our new diagnostic test.
Our paper-based microfluidics device measures drug-induced changes in blood viscosity without the need for external accessories. We believe that this technology is a scalable platform with a broad range of product opportunities. Current commercial POC devices generally use electrochemical technology with electrical current detection for quantitative assessment of the clotting time. Central to this technology are test strips impregnated with various chemicals that interact with the applied blood sample. Furthermore, electrical current end-point determination requires an electrical reader unit. In contrast, our microfluidics diagnostic test utilizes lateral flow technology on a commercially available paper strip. No materials are impregnated on the strip. Optical detection is simply accomplished by the human eye. With this in mind our technology has the following advantages:
- No need for external accessories, such as energy sources, chemicals, etc.
- Low bill of materials
- The ability to efficiently mass produce very large quantities of the test strips
- Applicable to all classes of anti-coagulant, including warfarin and exenatide
A provisional patent is pending.
For more information about our Point-of-care device 2014 CEAS Innovation Award Series: Steckl & Pauletti Prototype POC Diagnostic Testing Device