First Point-of-Care Heparin Monitoring Test Provides Results in Under 15 Minutes

Heparin dosing requires careful management to avoid both bleeding and clotting complications. In high-risk situations like extracorporeal membrane oxygenation (ECMO), mortality rates can reach about 50%, with bleeding occurring in over one-third of patients. Anti-Factor Xa tests, the preferred method for monitoring heparin therapy, are typically conducted in central labs and take over an hour to return results, leading to delays in crucial dosing decisions. Now, a new point-of-care heparin monitoring assay designed for patients receiving unfractionated or low molecular weight heparin offers results in under 15 minutes from just 50 µL of whole blood.

Baebies (Durham, NC, USA) has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its Anti-Factor Xa test on the FINDER platform. This designation highlights the test’s potential to bring heparin monitoring directly to the patient, enabling faster and more efficient dose management in critical care settings. Unlike existing tests, the FINDER Anti-Factor Xa Test requires no centrifugation and can be performed directly at the point of care or in a central lab, providing results within minutes. The test addresses a life-threatening condition, offers substantial improvements over current methods, introduces breakthrough technology where no approved alternatives exist, and aligns with the FDA’s Breakthrough Device criteria, ultimately benefiting patients.

"This designation provides priority FDA review and dedicated regulatory guidance, accelerating our efforts to bring the test to market," said Richard West, Founder and CEO of Baebies. "It positions FINDER to expand rapidly into the multi-billion-dollar coagulation testing space."

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