SBIR Phase I: Novel Optical Platform for Patient Self Monitoring of Coagulation in Whole Blood

This Small Business Innovation Research Phase I project develops a novel optical system for use in home monitoring of oral anticoagulation therapy, of particular benefit in situations where a patient is dangerously at risk of injury from a bleed. Current systems that are sold for use in home testing appear to have issues of precision and accuracy at the high end of the range, which may contribute to significant morbidity and mortality. In the period from 2006 to 2008 there were close to 4000 adverse events reported to the FDA associated with the use of this generation of handheld testing devices. In the most serious of these adverse events, the devices erroneously reported values within a clinically acceptable range, while the patient displayed clinical symptoms of bleeding, and laboratory tests showed that the patient was dangerously over anticoagulated. The detection system proposed in this project seeks to monitor the aggregation and dis-aggregation of rouleaux as an indicator of clot formation. The proposed optical system, if successful, is tuned particularly to the dis-aggregation of rouleaux and thus, will be more accurate and precise in the supratherapeutic range. There are three million people in the US who are on long term oral anticoagulant therapy and who would benefit from tighter control of their dosages enabled by the availability of home testing systems. The number of people who perform home testing has grown since Medicare first provided coverage in 2003 and then expanded coverage in 2008, yet currently the number of people who perform home testing represents only a small percentage of all persons eligible. As home testing becomes more popular, there can be expected a concomitant increase in the number of adverse events. Home test systems must give accurate results over their entire reporting range, as there is no opportunity for a health care professional to judge the result in the context of a patient?s clinical symptoms. When used properly, home test systems can be of particular value to those who find it difficult to visit a lab or clinic for regular testing, such as the elderly, the economically disadvantaged, and those who are geographically dispersed in rural areas. Development and commercialization of a home test system that implements the innovations proposed by this research is expected to increase the safety of home monitoring of oral anticoagulant therapy.