5-Minute Point-of-Care Anti-Factor Xa Test for Emergent Patient Management

ABSTRACT We are proposing to develop a multiplexed point-of-care anti-factor Xa (anti-Xa) and hemoglobin test to guide emergent management of bleeding and strokes in patients on anti-Xa direct oral anticoagulants (DOACs). This includes guiding appropriate treatment with andexanet alfa (andexanet, tradename ANDEXXA) during bleeds or thrombolytics for acute ischemic stroke (AIS). In this TABA Supplement to Direct-to-Phase II (D2P2) effort, we will augment our commercialization efforts by preparation and filing of patents related to the test, refine our regulatory strategy, and ensure our regulatory compliance. Currently about 16 million individuals are on direct oral anticoagulants, predominantly for nonvalvular atrial fibrillation, and ~500,000 per year are hospitalized with bleeds or breakthrough strokes. Proper therapeutic treatment require emergent and rapid measurement of anti-Xa activity. This TABA Supplement will lay the groundwork for future commercial activities. The success of developing a 5-minute anti-Xa test will allow for 10x faster responses to guide emergency management of patients and bring a much-needed capability to the point-of-care. A patient's presenting anti-Xa drug levels can vary widely, based on their peak and trough timing, drug dosage, drug clearance rate, and bioavailability. A 5-minute anti-Xa test allows guiding immediate management and timely follow-on measurements to allow tailored therapy. The rapid and cost-effective nature of the device will allow its use in ambulances, emergency rooms, and surgical suites. The simultaneous reporting of hemoglobin gives treating clinicians immediate information about the status of blood loss in the event of bleeding. The results of our efforts will be a rapid, cost-effective, monitoring device, consumable, app, and controls that will provide an urgently needed resource in light of recent developments in anti-Xa therapies.