Point of Care Blood Coagulopathy Diagnostics

We have developed a novel low-cost, multi-functional blood coagulation sensor that can measure a patient’s coagulation status within less than 10 minutes using a 25mL drop of blood. This device addresses the critical unmet need to identify and manage patients with an elevated risk of life-threatening bleeding or thrombosis, the major causes of in-hospital preventable death. In addition, our innovation will enable rapid coagulation testing in the home or primary care setting for over 15 million patients worldwide who routinely receive oral anticoagulants to prevent venous and arterial thrombosis, the world’s number one killer. Coagulation testing at the point of care is currently the fastest growing segment of the in vitro blood diagnostics market, with nearly $2 billion in global annual sales. Driven by the immediate need for improved blood product utilization and the rapidly growing numbers of patients receiving anti-coagulants worldwide, the coagulation testing industry is expected to burgeon by nearly 10-fold over the next decade. The blood coagulation sensor described in this proposal is well positioned to have a significant competitive advantage over other point of care coagulation devices. This is because current devices can only measure clotting time and often fail to identify the underlying coagulation defect. As a result, additional time-consuming laboratory tests are yet performed to assess relevant parameters: clot rate, fibrinogen, and fibrinolysis parameters, to reveal the underlying cause of bleeding or thrombosis. Current mechanical viscoelastic assays such as thromboelastography (TEG) can quantify these parameters in real-time; however, due to high cost, large size, complex operation and large blood volumes, these devices are unsuitable for use at the patient’s bedside. Our proposed coagulation sensor uniquely combines the strengths of a low-cost, palm-sezed module with the capability to quantify multiple relevant coagulation parameters required to diagnose the underlying coagulation defect within a fraction of the time and at the cost of current devices. Our approach, we term integrated coagulation laboratory (iCoagLab), involves placing a drop of blood in a 3-channel, disposable cartridge. A laser source, similar to a common laser pointer illuminates the blood sample and a small camera images laser speckle patterns reflected from the sample over time. By analyzing laser speckle intensity fluctuations in real-time, we can measure the viscoelastic properties of blood during coagulation and recover information about multiple coagulation metrics within minutes. iCoagLab’s capabilities for comprehensive coagulation profiling at the bedside will have major clinical impact in identifying patients at high risk of bleeding or thrombosis, tailoring blood transfusion and anti-coagulation protocols, and monitoring hemostasis during therapy to improve patient outcome.