Bleeding Risk Diagnostic Test to Reduce Preventable Complications in Hospitals

By LabMedica International staff writers
Posted on 19 Oct 2023

Image: The bleeding risk diagnostic test determines blood clotting status and whether a patient is on blood thinners (Photo courtesy of FloBio)

Millions of people rely on Direct Oral Anticoagulants (DOACs) to manage conditions like atrial fibrillation and deep vein thrombosis. These medications are efficient but pose an increased risk of bleeding, making emergency medical treatment challenging. Current bedside diagnostics don't effectively assess the status of DOACs in a patient, complicating the management of bleeding during traumatic incidents, surgeries, strokes, and other health emergencies. Serious bleeding episodes associated with these anticoagulants can result in up to 20% mortality within a month, extend hospital stays, and increase the likelihood of readmission. Now, a rapid bleeding risk diagnostic test can evaluate blood clotting status and identify if a patient is taking DOACs. This knowledge allows emergency and critical care providers to make informed decisions on drug reversal, which can minimize severe bleeding, a significant cause of avoidable complications and fatalities in hospitals.

FloBio (Philadelphia, PA, USA) is developing the first accurate, point-of-care test to detect DOACs that will aid emergency medical staff in deciding whether to administer medications that counteract DOACs' effects. Designed for in-vitro diagnostic purposes, this automated test offers a complete picture of a patient's blood clotting status after factoring in the anticoagulant effects of these blood thinners. The innovative device platform integrates hemodynamic flow with discrete clot activation to mimic physiological blood clotting. This allows for a quick and thorough evaluation of DOAC levels right at the patient's bedside. The U.S. Food and Drug Administration has granted Breakthrough Device Designation for FloBio’s rapid bleeding risk diagnostic test.

"Every year hundreds of thousands of Americans taking DOACs experience emergencies. It is critical that physicians have tools to rapidly detect DOACs so they definitively know whether to proceed with drug reversal to safely manage patients," said Jerri Ann Thatcher, Founding CEO. “We are encouraged that the FDA has recognized that our device has the potential to provide more effective diagnosis and treatment of life-threatening diseases and conditions. Our team looks forward to working with the FDA to accelerate the development, assessment, and commercialization of our technology, which so clearly fills a void in the market.”

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