Baebies, a North Carolina-based diagnostics company, has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its Anti-Factor Xa test on the FINDER® platform. The test represents the first point-of-care heparin monitoring assay, designed to provide results in under 15 minutes using just 50 µL of whole blood from patients receiving unfractionated or low molecular weight heparin.
The FDA designation recognizes the test's potential to significantly improve heparin monitoring by bringing it closer to the patient, enabling faster and more effective dose management in critical care settings where timely anticoagulation decisions can be life-saving.
"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."
Critical Need in Anticoagulation Management
Heparin dosing requires tight control to prevent both bleeding and clotting complications. The stakes are particularly high in settings such as extracorporeal membrane oxygenation (ECMO), where mortality rates often reach approximately 50%, and bleeding occurs in more than one-third of patients.
Anti-Factor Xa tests are the preferred method for guiding heparin therapy. However, current testing options are confined to central laboratories and typically take over an hour to deliver results, creating dangerous delays in time-sensitive dosing adjustments.
Dr. Sitaram Emani, Associate Professor of Surgery at Harvard Medical School, who has collaborated with Baebies on the technology, commented: "It is rewarding to see our long-standing, NIH-funded collaboration with Baebies achieve FDA breakthrough. I look forward to the test supporting timely anticoagulation decisions and advancing heparin management."
Technical Advantages Over Existing Methods
The FINDER Anti-Factor Xa Test offers several significant advantages over current testing methods. It requires no centrifugation and can be run directly at the point of care or in a central lab, delivering results in minutes rather than hours.
The test meets all FDA Breakthrough Device criteria by addressing a life-threatening condition, offering substantial advantages over existing methods, introducing breakthrough technology where no cleared alternatives exist, and serving the best interest of patients.
Expanding Diagnostic Capabilities
Founded in Research Triangle Park, North Carolina, Baebies has delivered over 22 million tests globally and is recognized as a technology leader in digital microfluidics (DMF). The company's multifunctional FINDER platform supports chemistry, immunoassay, molecular, and coagulation testing from small-volume samples.
"We're growing beyond our pediatric roots to serve broader populations by bringing multifunctional diagnostics to patients of all ages, wherever care is delivered," said Vamsee Pamula, PhD, Founder and President of Baebies.
The Breakthrough Device Designation will help accelerate the regulatory review process, potentially bringing this innovative technology to clinical settings sooner. For patients requiring heparin therapy, particularly those in high-risk situations, this advancement could significantly improve monitoring precision and treatment outcomes by enabling real-time dose adjustments based on rapid test results.
Market Impact and Future Directions
The breakthrough designation positions Baebies to enter the multi-billion-dollar coagulation testing market with a disruptive technology. By addressing the critical gap in point-of-care heparin monitoring, the FINDER platform could transform standard practices in intensive care units, cardiac surgery, and other settings where anticoagulation management is crucial.
Healthcare facilities currently relying on central laboratory testing for Anti-Factor Xa levels may soon have access to a bedside alternative that dramatically reduces result turnaround times, potentially improving patient outcomes while streamlining clinical workflows.
