FloBio has received breakthrough device designation from the US Food and Drug Administration (FDA) for its rapid bleeding risk diagnostic test.
The test is intended for delivering effective treatment or diagnosis of debilitating diseases or life-threatening conditions.
It assists in ascertaining blood clotting status and whether a patient is taking direct oral anticoagulants (DOACs).
This information could assist emergency and critical care clinicians in making informed treatment decisions regarding drug reversal to minimise severe bleeding, a leading contributor to preventable complications and fatalities in US hospitals.
Millions of Americans rely on DOACs, an effective medication for treating atrial fibrillation and deep vein thrombosis. DOACs can increase the risk of bleeding and the complexity of emergency care.
FloBio stated that it is developing the first precision point-of-care DOAC detection test, aimed at assisting emergency medical professionals in making better-informed decisions, including the choice of drugs to reverse the impacts of DOACs.
Created for in-vitro diagnostic purposes, the automated haemodynamic assay provides a comprehensive assessment of a patient's blood clotting status, including that of anticoagulation due to DOACs.
The novel device platform integrates haemodynamic flow with discrete clot activation to mimic physiological blood clotting and deliver a thorough DOAC drug evaluation at the patient’s bedside.
FloBio founding CEO Jerri Ann 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.”
