FloBio Introduced Novel Bleeding Risk Diagnostic Test

FloBio has introduced a novel diagnostic test that addresses the critical need for rapid detection of bleeding risk, specifically in patients using direct oral anticoagulants (DOACs), which are commonly prescribed blood thinners.

This diagnostic test offers significant potential benefits for healthcare professionals, particularly emergency and critical care clinicians.

The device is designed to determine a patient's blood clotting status, with a focus on detecting whether the individual is on DOACs. This information can be invaluable in making informed decisions about the treatment of patients at risk of serious bleeding.

The test is designed for in-vitro diagnostic use, and it employs an automated haemodynamic assay that provides a comprehensive picture of the patient's blood clotting status, including the influence of DOACs. This innovative device combines haemodynamic flow and discrete clot activation to closely replicate physiological blood clotting, allowing for rapid and accurate DOAC drug assessments.

Serious bleeding is a major cause of preventable complications and death in U.S. hospitals, and the ability to quickly assess a patient's DOAC status can be crucial in managing these situations.

The diagnostic test apart is its precision and point-of-care capability it allows medical professionals to assess a patient's DOAC status right at the bedside, making it a valuable tool for emergency situations.

Millions of Americans use DOACs to manage conditions such as atrial fibrillation and deep vein thrombosis. While these drugs are highly effective, they can also elevate the risk of bleeding, especially in emergency situations.

Prior to this breakthrough, clinicians lacked effective bedside diagnostics to assess a patient's DOAC status, making it challenging to adequately prevent or manage bleeding, particularly during traumatic events, invasive surgeries, strokes, and other medical conditions.

U.S. Food and Drug Administration has granted breakthrough device designation for its rapid bleeding risk diagnostic test.