FLoBio LLC, in conjunction with researchers at the University of Pennsylvania, has pioneered low volume microfluidic assays to monitor blood function under diverse disease and pharmacological conditions. Utilizing over a decade of experience with protein micropatterning, microfluidics, novel fluorescent biosensors, and patient blood testing, the team has developed a point-of-care (POC) disposable chip that allows scalable manufacturing and reliable bedside emergency room (ER) use. Such single-use chips will be developed for rapid patient monitoring in the context of detection of direct oral anticoagulants (DOACs). In over 4 million treatment visits, direct oral anticoagulant (DOAC) such as apixaban, rivaroxaban, or dabigatran are prescribed. DOACs are used for stroke prevention in patients with atrial fibrillation (A-fib) and in the treatment of venous thromboembolism (VTE) or prevention of VTE following hip or knee arthroplasty. These drugs potently inhibit coagulation Factor Xa (FXa) or thrombin (FIIa). Unfortunately, these patients are at greater risk of bleeding following trauma or emergency elective surgery. For example, A-fib patients on DOACs that suffer a stroke are poor candidates for emergency lytic therapy. A technology for monitoring DOAC levels and clearance would address an unmet medical need to identify bleeding risk during trauma or surgery, especially in elder patients with poor renal clearance of a DOAC. FLoBio will implement Phase I research on the following Specific Aims: Manufacture of a single-use chip for detection of FXa inhibitors (FXi) or direct thrombin inhibitors (DTI), especially at levels below <50 ng/mL (< 100 nM) where clinicians specifically need diagnostic information; Development of an alpha unit for chip reading with robust chip operating protocols and data analysis for scoring DOAC levels; and placement of a unit for preliminary on-site tests using blood from consenting, non-emergency A-fib or VTE patients taking DOACs for comparison of chip readout with LCMS gold standard measurements made on stored plasmas. In Phase II, beta-units for chip reading will be developed and larger chip manufacturing runs will be implemented for deployment at a major trauma surgery site in the US and at major thrombosis treatment clinical center. In the US, this technology has the potential to benefit nearly 60,000 patients annually on DOACs that suffer stroke, trauma, or a major bleed.

Public Health Relevance

FLoBio LLC proposes to design, manufacture, and validate a novel microfluidic chip to monitor whole blood function including platelet, thrombin, and fibrin production under microfluidic conditions. The development of a technology that is small and easy to use will be essential for bedside monitoring of patients taking direct oral anticoagulants (DOACs) who suffer stroke, trauma, or major bleeding episodes. The need for rapid DOAC monitoring is an urgent unmet need widely recognized by clinicians. In the US, this DOAC detection technology has the potential to benefit nearly 60,000 patients on DOACs that suffer stroke, trauma, or a major bleed.

National Institute of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
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Special Emphasis Panel (ZRG1)
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Warren, Ronald Q
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Flobio, LLC
United States
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