# A rapid microfluidic diagnostic assay for the measurement of Direct Oral Anticoagulants from patient whole blood

> **NIH NIH R44** · FLOBIO, LLC · 2022 · $1,222,556

## Abstract

Abstract: Direct oral anticoagulants (DOACs) are becoming the preferred approach to managing
anticoagulation, particularly in thrombolytic disorders. DOAC use is anticipated to reach $30B globally in the next
five years, overtaking other anticoagulants such as warfarin. While highly effective, DOACs can elevate bleeding
risks, and complicate emergency care, which may include the use of expensive DOAC reversal agents. As current
diagnostics fail to adequately identify problems caused by DOACs, there exists growing safety concerns for this
class of drugs that are reinforced by the Joint Commission’s call for laboratory test monitoring, and evidence-
based approaches for safe DOAC, and reversal agent use. Whether treating a stroke/VTE/PE patient, heart
arrhythmia patient, or trauma/urgent surgery patient, the real-time determination of a patient’s state of
anticoagulation, including DOAC type (factor Xa inhibitor vs. direct thrombin inhibitor) is critical for rapid care
decisions to avoid adverse bleeding. A significant limitation of core laboratory detection of DOACs is the length
of time to results, which can exceed more than the typical 20-minute decision making window. FloBio is
developing the first DOAC in vitro diagnostic product to provide physicians with rapid knowledge of
anticoagulation state in emergency care settings. With our analyzer/imaging station, and disposable DOAC assay
cartridge/microfluidic device, our novel approach combines hemodynamic flow, and discrete clot activation, to
mimic physiological blood clotting. In less than 10 minutes, a healthcare provider will know a patient’s relative DOAC
concentration, and the DOAC classification.
FloBio’s Phase I work has demonstrated a scalable, multiplex, disposable DOAC assay cartridge/microfluidic
device that facilitates the natural blood clotting cascade in vitro, an instrument for measuring assay signals,
analytic software to provide the end user with a simple outcomes assessment, and clinical data that validates
the feasibility of the assay and device to detect DOAC class and level in human blood. FloBio’s innovation is a
diagnostic assay that will be the first in the market to provide real-time data on fibrin and platelet accumulation
on basal vascular and coagulation proteins, under flow, that recapitulates in vivo coagulation processes.
In Phase II, FloBio will focus on validating the DOAC assay in a 100 subject clinical study at the University of
Pennsylvania. This study will validate the capability of the assay to detect both class and DOAC level, within a
clinical patient population. A second clinical study with DOAC spiked healthy adult blood will determine the
device, assay and system range, sensitivity, specificity, variance, and consistency. Clinical assay data will be
validated against the gold standard of detection, LCMS. Automation of critical assay functions will also be
evaluated to reduce variation in the assay, and the feasibility of a fully integrated, automatable...

## Key facts

- **NIH application ID:** 10482562
- **Project number:** 2R44HL149480-02A1
- **Recipient organization:** FLOBIO, LLC
- **Principal Investigator:** Adam Cuker
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $1,222,556
- **Award type:** 2
- **Project period:** 2019-09-01 → 2023-10-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10482562

## Citation

> US National Institutes of Health, RePORTER application 10482562, A rapid microfluidic diagnostic assay for the measurement of Direct Oral Anticoagulants from patient whole blood (2R44HL149480-02A1). Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/grant/nih/10482562. Licensed CC0.

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