Bleeding Risk Diagnostic Test to Reduce Preventable Complications 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.”

Related Links:
FloBio