New research study shows enhanced sensitivity of intrinsic-activated thrombin generation assay

We are proud to share the results of a research study that highlights an innovative intrinsic pathway approach to thrombin generation testing for monitoring treatment with non-factor replacement therapies in severe haemophilia A, developed by Coagulation Profile B.V. in close collaboration with scientists and clinicians at Maastricht University. The study, entitled “Intrinsic activated thrombin generation for treatment efficacy and monitoring of octocog alpha and emicizumab in severe hemophilia A,” has been accepted for publication in Research and Practice in Thrombosis and Haemostasis [1].

Maintenance treatment with novel non-factor replacement therapies such as emicizumab requires little routine monitoring; however, in clinical situations such as during an operation or when switching therapies, accurate monitoring of drug levels becomes critically important. Conventional assays such as activated partial thromboplastin time (APTT) tend to overestimate the therapeutic efficacy due to interference from of these novel agents, potentially putting patients with severe haemophilia A at increased risk of bleeding.

To address this challenge, the team at Coagulation Profile BV hypothesised that triggering thrombin generation via the intrinsic coagulation pathway would improve sensitivity in the presence of non-factor therapies, leading to the development of a novel intrinsic trigger reagent called PPP Reagent INT. In the study, testing the PPP Reagent INT thrombin generation assay on plasma samples from healthy donors and patients with severe haemophilia A demonstrated up to sixfold greater sensitivity to changes in both factor VIII and non-factor therapies compared with standard reagents, leading the study team to conclude that intrinsic-activated thrombin generation holds promise as a future tool for monitoring novel non-factor therapies in clinical practice.

At Coagulation Profile, we are proud to contribute our analytical expertise to research that advances safer, faster solutions for managing haemostasis and optimising patient care. This work reflects our ongoing commitment to scientific excellence in the fields of thrombosis, haemophilia and vascular biology. Find out how your development programme can benefit from our broad experience and comprehensive knowledge by contacting us at info@coagulationprofile.com or visiting www.coagulationprofile.com.

Reference:

1. Urlings EH, Heubel-Moenen FCJI, van Oerle R, et al. Intrinsic activated thrombin generation for treatment efficacy and monitoring of octocog alpha and emicizumab in severe hemophilia A. Volume 10, Issue 4, May 2026, 106627.