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.

Grant Number: 3R44HL170817-01A1S1
NIH Institute/Center: NIH
Principal Investigator: Eugene Chan