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Reference Case: PoC Test to Improve Diagnosis & Disease Monitoring of Chronic Kidney Diseases



Interview: Loek Willems, Wieke de Bruin & Erik Toonen

Hycult Biotech


Get to know the team behind the Hycult Biotech project in our exclusive Q&A featuring Loek Willems, Wieke de Bruin, and Erik Toonen. Find out more about Hycult, gain insight into their application, and learn about their experience with the Open Call and how it has impacted their project.



Can you tell us a bit about Hycult Biotech and what the company does exactly?

For 29 years, Hycult Biotech has been an independent, family-owned Dutch company dedicated to developing and manufacturing antibodies, proteins, and ELISA kits. Our products are utilized in immunology research worldwide, ranging from academia to pharmaceutical companies. We are committed to creating tools for innate immunity research, with specialism in complement and related diseases. Our team of scientists also participates in various international academic projects, focusing on next-generation biomarkers for specific diseases or treatments. Moreover, through our subsidiary Biocult, we leverage our experience in the design and scaling of monoclonal antibodies and assays to offer services to startups and diagnostic companies.


What was the motivation behind your application to the Open Call?


We have a unique opportunity to apply our existing technology and in-house expertise to new and innovative concepts. Our focus is on developing high-quality antibodies for the complement system and their use in immuno assays. As the field of complement therapeutics continues to rapidly expand, it is crucial to bridge the gap between academic/ pharmaceutical research and the long-term need for novel diagnostic tools. Due to the complexity of complement analysis, standard methods may not be adequate, resulting in an unmet need for reliable diagnostic tools. Leveraging our experience, we are confident in our ability to develop reproducible and user-friendly methods that can aid in treatment decisions for complement-related diseases. By the end of the project, we aim to have a prototype test that we can evaluate with specialists in the field.



How did you find the Open Call application process?

Wieke de Bruin, Head of Research and Development

The process of joining the Open Call program was relatively straightforward from our perspective. The program managers and lead partner GENSPEED quickly introduced us to the available options and benefits of participating. It felt like a natural brainstorming session where we explored how we could leverage our collective strengths. The primary criteria for securing funding, apart from the required financial investment, were having a clear vision and a well-thought-out plan. By preparing a comprehensive pitch that highlighted our concept and market potential, we were able to successfully persuade the program board to support our proposal.


Describe briefly the problem you introduced to the Open Call and how the MIH members address it?


There is a significant and urgent need for a non-invasive diagnostic test that can facilitate early detection and monitoring of chronic kidney diseases (CKD). The current diagnostic tests available for CKD are inadequate, as the disease often presents silently, with up to 9 out of 10 individuals being unaware of their condition. Although complement analysis has shown promise as an early indicator of kidney disease, the current method of diagnosis requires kidney biopsies, which is invasive and impractical. With our expertise in the field and GENSPEED's proven success in developing quantitative point-of-care tests, we are confident that we can collaborate to develop a supporting test that utilizes blood or urine as a more accessible alternative to kidney biopsies.


What would you say the Open Call specifically provides you with which you would not have achieved on your own?


Physicians prefer point of care tests above various single plex assays such as ELISA, especially because it is less laborious and provides faster results. Other platforms fail to measure complement markers in a multiplex setting with reliable outcome. We would like to bring our specific antibodies to a multiplex platform that can be trusted and offers ease of use. The MIH program helps us, at an affordable budget, to investigate the use of a microfluidic system as an alternative multiplex platform.


Loek Willems, Business Manager (L) & Erik Toonen, R&D Scientist (R)

The MIH introduced your problem to its 20 members whose capabilities and expertise cover the entire microfluidics value chain, what's your view on accessing a wide range of services through a single entry point?


One major advantage of participating in the program is that, while we are in the process of creating the design for our product, other MIH partners are already exploring the scalability of the product through roll-to-roll manufacturing. This is an area that we would have previously only explored incrementally after successfully designing the prototype. By tackling this issue in parallel, we can ensure that upscaling challenges are addressed and resolved in a timely manner, allowing for rapid production once the prototype assay has been accepted by early adopters. Additionally, the program offers access to industrial partners and ambassadors in the field, which expands our network beyond our current connections, making it even more attractive.


How do you feel about the current state of your project with the MIH?


We are currently in the initial stages of development and have already begun exchanging reagents and expertise with our MIH partners. Their proactive approach gives us confidence that we are receiving guidance throughout the process. Simultaneously, we are actively seeking to engage with key opinion leaders in the field of complement diagnosis or therapeutics to generate interest in our project. This will enable us to promptly initiate feasibility testing of the prototype assay in relevant disease models.


What are your plans after the program?


Once the prototype is accepted and market size can be addressed, we will look into the regulatory aspects of bringing this to market. We need to address specific claims as diagnostic or monitoring tool in relation to envisioned therapy. Atleast we could bring this interesting tool to the research market as supporting tool for complement therapeutic trials. Together with GENSPEED, we would be highly motivated to explore diagnostic options around our current ideas.


What would you advice other projects interested in applying to the Open Call?


Consider unconventional plans that are beyond your current technical capabilities. If you envision expanding into a different market but lack the necessary expertise or funds, this program provides an accessible and affordable solution. The Open Call offers a significant boost to your budget, making previously unattainable goals more feasible. If you possess intellectual property, such as reagents or assay designs, consider how modifying them could make them more attractive in a different market. Additionally, creating new content for existing products to address unmet medical needs could bring you closer to seemingly unachievable goals.


#Roll-to-Roll


DOWNLOAD the 2-page data sheet to find out more about the project:

Reference Case_Hycult
.pdf
Download PDF • 1.25MB


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