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Innovative start-up helps doctors, scientists and industry balance coagulation risks

For many doctors caring for seriously ill patients, for example, in stroke units and cancer wards, maintaining the life-saving balance between bleeding and thrombosis is an ongoing challenge. In the late 1980s, scientists at Maastricht University in the Netherlands developed an innovative method, the thrombin generation assay (TGA), which provides a complete overview of a physiological process crucial for maintaining normal haemostasis.

Coagulation is the process whereby the body stops bleeding at the site of an injury by mobilising platelets and plasma factors to form a blood clot. Healthy coagulation is essential to maintaining the delicate haemostatic balance between bleeding and thrombosis; any disruption to the system for any reason can quickly have life-threatening consequences. In fact, according to the World Health Organization, ischaemic heart disease and stroke caused more than 15 million deaths in 2016, equivalent to one in four of all deaths in the whole world that year.

An individual's ability to produce coagulation components and form a blood clot is referred to by specialists as the coagulation profile. In the university city of Maastricht in the Netherlands, Coagulation Profile B.V. is also the name of a specialist provider of analytical services and assay development in the fields of thrombosis and haemostasis. "Coagulation Profile started in 2018 as a spin-off from Maastricht University", explains Dr Henri Spronk, founder and CEO. "A team of seven eminent scientists in the fields of thrombosis, haemophilia and vascular biology came together to create a contract research service provider capable of supporting practice-changing research and development across the whole spectrum of coagulation disorders."

Six years on, Coagulation Profile has become an established research partner and service provider for pharmaceutical and biotech companies around the globe, renowned for its portfolio of high-quality standard and custom-made coagulation marker assays available for preclinical and clinical research under GLP and GCP conditions. Targets include coagulation markers related to the vessel wall (such as ucMGP and PIVKA-II) and blood (ranging from standard PT and aPTT assays to custom-made antigen and enzyme activity assays), as well as flow assessments including the Maastricht Flow Chamber and thromboelastography.

Coagulation Profile specialises in the TGA, a highly sensitive method that captures both pro- and anticoagulant mechanisms in the same analysis, thus providing a complete picture of a patient's risk of bleeding or developing thrombosis at a given point in time. Dr Spronk explains that thrombin generation is a critical step in the coagulation process, and dysregulation of thrombin generation has been shown to play a part in inherited and acquired bleeding disorders, as well as in thrombotic disorders such as DVT, ischaemic stroke, and cancer-associated thrombosis. A very important clinical application of the TGA is for monitoring treatment with bypassing agents or non-factor therapies in haemophilia A or B with inhibitors. More recently, the COVID-19 pandemic has highlighted the need for accurate and sensitive continuous monitoring to minimise risk and optimise therapy in infection-related coagulopathy.

"A limitation with standard assays such as PT or aPTT is that they only capture part of the coagulation process," says Dr Spronk. "TGA is a global assay that captures both the formation and decay of thrombin simultaneously, which means it better reflects in vivo conditions." The TGA assay offered by Coagulation Profile has been developed in collaboration with the Department of Biochemistry at Maastricht University and includes validated protocols for controlling pre-analytical conditions and limiting variability due to coagulation and platelet activation during sample collection and preparation. Standardised reagents, state-of-the-art instrumentation and reference ranges for thrombogram parameters derived from large-scale population-based study data add further value to the Coagulation Profile TGA as a versatile tool across a range of R&D applications, including preclinical and clinical drug development.

Like all products and services offered by Coagulation Profile, the TGA has been brought to market by a team of dedicated scientists who, between them, have authored more than 1,000 peer-reviewed publications. Find out how your preclinical and clinical drug development programme can benefit from the Coagulation Profile team's broad experience and comprehensive knowledge by contacting info@coagulationprofile.com or visiting www.coagulationprofile.com.

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