The innovative diagnostic company Enzyre, has medical diagnostic device development at the heart of its business. Waander van Heerde, Chief Scientific Officer of Enzyre, updates us on the companies’ vision for the future.
As an innovative spin-off company of the Radboudumc hospital, Enzyre has recently received a European EFRO grant of two million euros, being the lead company of a larger consortium with high-tech and med-tech companies. The grant was awarded for the development of a Hemophilia Biochip in combination with a successful seed financing round from business angels and existing shareholders like the Radboudumc, the University Medical Center in Nijmegen, The Netherlands. The funding will pave the way for a two-year period development plan of the Hemophilia Biochip. This will help patients living with Hemophilia to increase control over their hereditary disease management. Enzyre envisions that the availability of point-of-care diagnostic tests will have a large impact on treatment and management of hemophilia since personalized treatment regimens will result in less life-threatening bleeding episodes and side-effects for patients and reduce healthcare costs for society.
With an increasing desire for sustainable and independent healthcare provisions in the home setting, the healthcare sector requires more independent and digital solutions for monitoring therapeutic dosing in for example hemophilia patients. Enzyre took the important decision to miniaturize current coagulation factor activity measurements, thereby moving the testing to hemophilia patients in the home setting rather than the doctor’s office.
To ensure increased patient safety and prevent dangerous situations, the Enzyre team strives to develop a portable point-of-care device that will enable patients to experience increased control of their coagulation status during the day and prevent hazardous situations that may occur during exercise and sports, but also during normal, daily activities.
The first application Enzyre aims to develop is the Hemophilia Biochip for the management of patients with hemophilia. Other uses of the Biochip have been identified like the emergency care setting and monitoring of anticoagulants at home. The expectation is that the current Biochip platform will also be applicable for other therapeutic areas. The wider application of the current technology will reduce costs and will allow us to make our technology also available for patients in non-western countries.
The Hemophilia Biochip prototype will be equipped with a mobile app to enhance the patient experience of monitoring and safety across the clinical needs encountered. The digital tools developed, will use algorithms to provide real-time and diagnostic insights, with the purpose to increase quality of life of the patient.
Patients with severe hemophilia are visiting their Hemophilia Treatment Centre usually twice a year. Most adult severe hemophilia patients treat themselves based on a dosing schedule determined by the hematologist. These dosing regimens are based on the outcome of a single pharmacokinetic analysis in which the hematologist will treat the patient with a single dose of its lacking therapeutic coagulation factor and monitor the subsequent decrease of coagulation factor over time. After this analysis the dosing regimen is only adjusted upon empirical observations in clinical practice. If bleeds occur more frequently than anticipated, the treatment dose is increased. In the absence of bleeds, the hematologist tends to reduce the dosing, driven by a societal desire for cost-effectiveness. In all situations, the patient lacks control of treatment, because the responsibility of compliance is handed over to the patient without providing him with regular nor sufficient information. Retrospective studies showed that therapy adherence was only 53 per cent in patients with hemophilia. With the Hemophilia Biochip all stakeholders in hemophilia care can collectively contribute to a reduction of costly hospital visits, reduce waiting times and allow efficient remote patient-caregivers meetings, ultimately resulting in improved patient quality of life. Moreover, the biochip is likely to contribute to an increased adherence and facilitate personalized and more effective treatment in the comfort of the patients’ own home.
Figure 1. A schematic representation of the Hemophilia Biochip (AB) with the blood collection device of Seventh Sense (C).
Enzyre collaborates with a consortium of high-tech companies of which several are located at the Novio Tech Campus in Nijmegen, The Netherlands. The sensors will be delivered by NXP and high-tech partners Sencio and EPR will take responsibility for sensor packaging and electronical engineering of the printed circuit boards. Enzyre has developed miniaturized biochemical tests to be able to measure the coagulation status in just a single microliter of blood and will validate the tests in the Hemophilia Biochip platform. Together with the Radboud University Enzyre will further optimize the chemical compounds for the tests. The Hemophilia Treatment Center Nijmegen-Eindhoven-Maastricht will be the clinical partner to perform clinical studies with prototypes and initial products assuring that patients receive the best possible experience when accessing these novel services.
The Enzyre team is working lean and smart with ample experience in their research and development team from a laboratory background. Recently, Dirk Pollet was appointed CEO. Dirks brings more than 25 years of experience in the diagnostics and biotechnology industries. Dirk led Multiplicom NV, a European diagnostics company which was acquired by Agilent Technologies. Furthermore, Dirk held senior positions at Cellectis SA, Galapagos NV and Innogenetics NV. The recently obtained grant will support the growth of Enzyre to about 15 staff members, encompassing project managers and support staff for technical development of the prototype and experienced experts in quality and regulatory matters.
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