SBIR Phase I: Automated DOAC assay to determine coagulation status in emergent care

The broader impact/commercial impact potential of this Small Business Innovation Research (SBIR) Phase 1 project is a diagnostic product that addresses patient safety and clinical decision-making for physicians managing patients taking Direct Oral Anticoagulants (DOACs). DOACs are becoming the preferred drugs to reduce the risk of blood clots that can lead to significant adverse events, such as stroke. However, DOACs are part of the leading class of drugs implicated in adverse event-related emergency department visits. These adverse events place a significant burden on the healthcare system in the form of transfusions, exposure to blood products, platelet repletion, reversal therapies, and additional complications (e.g. infection, sepsis, multiple organ failure) driving longer hospitalizations, higher mortality rates, and escalating healthcare costs. In emergency situations, the rapid detection of DOAC anticoagulation is needed when planning for urgent care for surgery, serious trauma, drug overdose, emergency procedures, or monitoring for drug accumulation in cases of renal and liver failure. This project proposes a diagnostic at the point of care. With an estimated 21 M patients globally taking DOACs, this technology could significantly reduce the $2.5 B in costs related to treating and correcting adverse events caused by the absence of DOAC information in emergency care situations. This Small Business Innovation Research (SBIR) Phase I Project will demonstrate the feasibility of a point-of-care (POC) diagnostic chip for emergency room clinicians to manage bleeding risk and avoid overuse of drug reversal therapies, thereby improving patient outcomes while reducing healthcare costs. Currently there is no approved rapid diagnostic POC test that accurately identifies the type of DOAC drug a patient is using, nor how much of the drug is in the patient’s blood. An integrated microfluidic cartridge is proposed developed to manage blood distribution within the device, mix the blood with DOAC detection reagents, and provide an integrated assay result that evaluates the three important clotting factors in clot formation (fibrin/thrombin/platelets). The technology is unique in that, unlike other coagulation tests, it re-creates the blood clotting physiology, and characteristic blood flow, that happens within the body. With DOAC-reversing drugs, the diagnostic can determine DOAC type (Factor Xa or Factor IIa), and the level of DOAC in the blood, allowing emergency room physicians to make more informed care decisions. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.