We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

Features Partner Sites Information LinkXpress hp
Sign In
Advertise with Us
INTEGRA BIOSCIENCES AG

Baebies

Baebies develops and commercializes products and services that enable early disease detection and comprehensive diagn... read more Featured Products: More products

Download Mobile App




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

By LabMedica International staff writers
Posted on 08 May 2025

Heparin dosing requires careful management to avoid both bleeding and clotting complications. More...

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."


Gold Member
Fully Automated Cell Density/Viability Analyzer
BioProfile FAST CDV
Verification Panels for Assay Development & QC
Seroconversion Panels
New
PSA Test
Humasis PSA Card
New
Creatine Kinase-MB Assay
CK-MB Test
Read the full article by registering today, it's FREE! It's Free!
Register now for FREE to LabMedica.com and get access to news and events that shape the world of Clinical Laboratory Medicine.
  • Free digital version edition of LabMedica International sent by email on regular basis
  • Free print version of LabMedica International magazine (available only outside USA and Canada).
  • Free and unlimited access to back issues of LabMedica International in digital format
  • Free LabMedica International Newsletter sent every week containing the latest news
  • Free breaking news sent via email
  • Free access to Events Calendar
  • Free access to LinkXpress new product services
  • REGISTRATION IS FREE AND EASY!
Click here to Register








Channels

Clinical Chemistry

view channel
Image: The GlycoLocate platform uses multi-omics and advanced computational biology algorithms to diagnose early-stage cancers (Photo courtesy of AOA Dx)

AI-Powered Blood Test Accurately Detects Ovarian Cancer

Ovarian cancer ranks as the fifth leading cause of cancer-related deaths in women, largely due to late-stage diagnoses. Although over 90% of women exhibit symptoms in Stage I, only 20% are diagnosed in... Read more

Immunology

view channel
Image: The cancer stem cell test can accurately choose more effective treatments (Photo courtesy of University of Cincinnati)

Stem Cell Test Predicts Treatment Outcome for Patients with Platinum-Resistant Ovarian Cancer

Epithelial ovarian cancer frequently responds to chemotherapy initially, but eventually, the tumor develops resistance to the therapy, leading to regrowth. This resistance is partially due to the activation... Read more

Pathology

view channel
Image: AI-analyzed images from the FDM microscope show platelet clumps in motion (Photo courtesy of Hirose et al CC-BY-ND)

AI Microscope Spots Deadly Blood Clots Before They Strike

Platelets are small blood cells that act as emergency responders in the body, rushing to areas of injury to help stop bleeding by forming clots. However, sometimes platelets can overreact, leading to complications.... Read more

Technology

view channel
Image: The new algorithms can help predict which patients have undiagnosed cancer (Photo courtesy of Adobe Stock)

Advanced Predictive Algorithms Identify Patients Having Undiagnosed Cancer

Two newly developed advanced predictive algorithms leverage a person’s health conditions and basic blood test results to accurately predict the likelihood of having an undiagnosed cancer, including ch... Read more
Copyright © 2000-2025 Globetech Media. All rights reserved.