The Philadelphia-based FloBio has designed the precision, point-of-care test Direct Oral Anticoagulant detection test to aid emergency medical professionals make more informed choices
FDA has granted breakthrough device designation to FloBio’s DOAC detection test. (Credit: Michal Jarmoluk from Pixabay)
Medical diagnostics company FloBio has received breakthrough device designation from the US Food and Drug Administration (FDA) for its rapid bleeding risk diagnostic test.
The Philadelphia-based company has designed the precision, point-of-care test Direct Oral Anticoagulant (DOAC) detection test to aid emergency medical professionals in making more informed choices.
The test is intended to detect blood clotting status and determine whether a patient is on DOACs, which are blood thinners that are commonly used to manage atrial fibrillation and deep vein thrombosis.
The rapid, actionable information would aid emergency and critical care professionals in making well-informed judgments regarding drug reversal to lessen serious bleeding, which is a significant contributor to avoidable complications and fatalities in American hospitals.
The automated haemodynamic test, which was created for in-vitro diagnostic application, provides a thorough analysis of a patient’s blood clotting state, including anticoagulation brought on by DOACs.
FloBio founding CEO Jerri Ann Thatcher said: “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.
“We are encouraged that the FDA has recognised 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 commercialisation of our technology, which so clearly fills a void in the market.”
The device platform combines discrete clot activation with haemodynamic flow to imitate physiological blood clotting. It then generates a thorough DOAC medication assessment at the patient’s bedside in a few minutes.
According to the medical diagnostics firm, the FDA status will enable the device to offer more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
FloBio, a spinout from the University of Pennsylvania, is also developing a new point-of-care IVD platform with its first DOAC test granted the breakthrough status.