Introduction

Every hour 11 people in the Netherlands are diagnosed with thrombosis! Thrombosis is a medical condition in which blood clots form in the blood vessels, disrupting the normal blood flow. Almost all heart attacks and strokes are caused by thrombosis. One in four deaths worldwide is due to thrombosis. There are a number of risk factors for thrombosis, such as immobility, recent surgery, smoking, obesity, pregnancy, use of contraception and genetic predisposition. But diseases and conditions, such as cancer, chronic inflammatory diseases, chronic kidney disease, chronic lung disease, migraine and infectious diseases can also increase the risk of thrombosis. It has recently been established that Long-Covid syndrome is also associated with an increased risk of thrombosis, partly due to the viral infection and associated infection. Unfortunately, existing antithrombotic therapy is not or hardly effective in seriously ill COVID patients.

The serious consequences of thrombosis can be significantly reduced if it can be detected early. Preventive measures can then be taken, such as compression stockings or the prescription of antithrombotic drugs such as platelet inhibitors or coagulation drugs (usually called “blood thinners”). Unfortunately, the dosage of antithrombotic drugs is complex, because the correct dosage depends on personal factors such as age, weight, genetic predisposition and any other diseases. Too high a dose of this medication can lead to internal bleeding, which can be life-threatening. It is therefore essential that antithrombotic drugs are dosed carefully. Regular monitoring by a doctor is necessary to ensure that the dose is effective and the risk of bleeding is minimized. Doctors would prefer to fully tailor the dosage to the individual patient, but lack the necessary measuring instruments for this. An easy-to-use, accurate and cheap device to perform this measurement quickly is being developed in this project.

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PC200 Point-of-Care Testing Device (POCT)

In the PC200 project we will turn the current proof of concept into a market-ready product. The PC200 is an innovative Point-of-Care Testing Device (POCT) to measure biomarkers like P-selectin. P-selectin present in the blood serves as a valuable biomarker for predicting thrombosis and assessing treatment efficacy, providing critical insights to medical professionals. The current measurement techniques are either expensive or require a lot of labor and are therefore only used in research facilities.

The PC200 can quickly and accurately measure platelet activation by measuring P-selectine optically, at a fraction of the cost of existing biochemical measurement methods. The proof of concept for this has already been demonstrated in a completed REACT-EU project. This project focuses on the further development of a market-ready version of the PC200, including the necessary reagents and disposables for measurements. Clinical studies will be conducted at Maastricht UMC and St. Antonius Hospital in Nieuwegein to validate the effectiveness of the PC200 in various patient groups with an increased risk of thrombosis: patients with heart attacks, strokes, pancreatic cancer, infectious diseases, and migraines. The significant potential of the PC200 to improve the diagnosis, monitoring, and treatment of these conditions will be tested and demonstrated in this project.

The PC200 operates by introducing a specific reagent to a blood sample, which binds to the targeted biomarker, inducing fluorescence. This fluorescence enables the optical measurement of biomarker concentration, facilitating rapid and accurate assessment of platelet activity. Beyond platelet activation tests, this versatile Point-of-Care Testing (POCT) device can also be adapted for detecting and measuring other blood biomarkers that can be fluorescently labeled, broadening its potential applications significantly.

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Benefits of Point-of-Care Testing Devices (POCT)

The PC200 fluorescent cell counter is an innovative Point-of-Care Testing Device (POCT) allowing medical diagnostic testing to be performed at or near the location where a patient is receiving care, rather than in a centralised laboratory. This approach enables faster decision-making by providing immediate test results, often within minutes, which is critical for timely diagnosis and treatment. Point-of-Care Testing (POCT) is characterised by its convenience and speed, providing diagnostic results directly at the patient’s location, such as a clinic, bedside, or home. It is designed for rapid results, often available within minutes, enabling faster decision-making and treatment. Additionally, POCT devices are user-friendly, allowing non-specialist healthcare providers or even patients to perform tests with ease. POCT will be in our opinion a cornerstone of modern healthcare, particularly in emergency, critical care, and remote settings, where quick and accurate test results can significantly impact patient outcomes.

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Early indicator of Thrombosis – P-Selectin biomarker

Thrombosis is a serious condition that causes blood clots, leading to heart attacks, strokes, and other life-threatening complications. Risk factors include immobility, surgery, chronic illnesses, and Long-COVID, which also increases thrombosis risk. Early detection using biomarkers like P-selectin, a molecule linked to platelet activity, offers a promising method for improving diagnosis and treatment. Personalized antithrombotic therapy is critical for minimizing risks, but current tools for precise dosing are inadequate. Developing accurate diagnostic tools is essential to support individualised care and reduce complications from thrombosis.

A promising approach for early detection of thrombosis and related conditions is measuring biomarkers, which are measurable characteristics used as indicators of diseases or conditions in the body. For thrombosis-related disorders, P-selectin is a highly specific and suitable biomarker.

P-selectin is a cell adhesion molecule found on the surface of activated platelets that are prone to clumping and causing thrombosis. It plays a critical role in the blood clotting process and serves as an indicator of increased platelet activity, and thus thrombosis risk. Elevated levels of P-selectin are associated with various conditions, including atherosclerosis, thrombosis, myocardial infarction (heart attack), stroke, and certain inflammatory diseases.

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Challenges with existing biomarker measurements

Measuring P-selectin is challenging due to the limitations of existing techniques. Current methods like FACS and ELISA are highly accurate but expensive, labor-intensive, and impractical for routine diagnostics. LTA, the only diagnostic method in some hospitals, is also labor-intensive and requires significant blood volumes, leaving many patients undiagnosed or diagnosed too late. There is an urgent demand for a new, cost-effective, and rapid test to measure P-selectin and improve diagnostic capabilities for thrombosis-related conditions.

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PC200 – innovative, optical-based device for measuring biomarkers

The PC200 is an innovative, optical-based device for measuring biomarkers like P-selectin, offering a faster, simpler, and more affordable alternative to traditional methods such as ELISA and FACS. With a low cost per test and results in short times, it makes biomarker-based diagnostics and monitoring feasible in clinical settings.

Applications include early thrombosis diagnosis, personalized medication dosing, and thrombosis prevention in at-risk patients. The PC200 helps reduce side effects, healthcare costs, and medication waste while improving patient care and outcomes. It is also a valuable tool for research into conditions like migraines and Long COVID, providing insights into the mechanisms of platelet activity and clot formation. In the PC200 also other biomarkers will be investigated for cardiovascular and oncology applications using the same fluorescent optical measurement principle. 

The PC200 builds on the PC100, an instrument we introduced to the market in 2018. While the PC100 focuses on platelet counting, the PC200 expands these capabilities to biomarker detection of fluorescent stained cells, significantly broadening its scope and applications. By integrating biomarker diagnostics into everyday healthcare, the PC200 represents a major leap forward in medical technology. Developed in collaboration with trusted partners, it is a key step toward more efficient, personalised, and impactful healthcare solutions.