Baebies has received Breakthrough Device Designation from the U.S. Food and Drug Administration for its Anti-Factor Xa test developed for the FINDER® platform. This is the first point-of-care test designed to monitor heparin therapy, delivering results in under 15 minutes using only 50 microlitres of whole blood. The test is intended for patients being treated with unfractionated or low molecular weight heparin and aims to support faster and more effective dose adjustments in critical care environments.
The Breakthrough Device Designation ensures the test receives priority review and dedicated guidance from the FDA, helping to speed up its route to market. It also opens opportunities for the FINDER platform to enter the wider coagulation diagnostics market, which is currently valued in the billions.
Heparin therapy demands precise dosing to avoid serious complications such as excessive bleeding or blood clots. This is especially important in high-risk settings like extracorporeal membrane oxygenation (ECMO), where mortality rates can reach 50% and bleeding occurs in over a third of patients. Anti-Factor Xa testing is the preferred method for managing heparin dosing but is currently limited to central laboratories, often requiring more than an hour for results. Such delays can impact patient care.
Baebies' new test addresses this gap by offering a rapid, easy-to-use solution that does not require sample centrifugation. It can be used directly at the point of care or in central laboratories, providing timely results that support urgent clinical decisions.
This development marks a significant step forward in heparin management. The test meets the FDA’s criteria for breakthrough technology by addressing a serious condition, offering clear advantages over existing options, and providing a solution where no approved alternatives are currently available.
