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Revolutionizing Anemia Detection: Microfluidics in Point-of-Care Diagnostics

Case study on point-of-care diagnostic device for iron deficiency and anaemia emplying a disposable microfluidic device.

Interview: Dr. Anna Zhenchuk

Managing Director, BioAnalyt GmbH

In our special interview with Dr. Anna Zhenchuk, she tells us about her company BioAnalyt, discusses the project, and gives us valuable insights into her team's experience with the Open Call. If you're interested in how the program has impacted their project, read on and learn more about the application process for the Open Call.

Could you tell us more about BioAnalyt and what the company does exactly?

BioAnalyt is a company that revolutionizes the field of food and nutrition analysis, making it more accessible, efficient, and impactful in addressing global nutrition and health challenges, particularly in resource-limited settings.

Since its founding in 1999, BioAnalyt has developed and commercialized 6 iCheck devices for measuring vitamins A and E, total carotenoids, iron, and iodine in food and biological samples, primarily supporting application areas in nutrition programs, animal health, and food quality, particularly for fortified foods. iChecks are currently used in over 60 countries by food and animal feed producers, governments, NGOs, and researchers.

Our current development focuses on developing and bringing to the market an analytical platform for single-drop analysis in the PoC diagnostic market. The first target application for this analytical platform focuses on the diagnosis of iron deficiency and associated iron deficiency anemia. Utilizing the multi-modal sensing technology of the platform enables early stage detection, diagnosis and monitoring of iron deficiency anemia both in clinical and field settings. Its portability and simplicity will transform iron deficiency diagnostics from acute to preventive, ultimately improving the health and well-being of individuals affected by this condition.

How did you find out about the MIH and the Open Call?

We found out about the MIH while attending the BioChip Conference in Berlin, where they had a booth set up. During an on-site discussion the team from MIH introduced us to their concept and the possibilities associated with the Open Call.

What was your motivation for applying to the Open Call and what is your expected outcome?

The possibilities that arise from working with an established network of partners which combine the whole expertise in the development and manufacturing of microfluidic components from the PoC to actual production got us really interested in applying to the Open Call. A further advantage arises from a shortened development time as the different companies within the network already have an established modus of operandi, are experienced in working together and are controlled by a joint project management. In addition, the possibility for funding made the collaboration even more interesting.

Our expected outcome is on the one-side a strongly improved consumable for our analytical platform and on the other hand valuable connections and insights with partners also for potential future projects and for the transfer of the developed product into the actual manufacturing process.

How did you find the application process? What specific criteria did you have to meet to receive funding?

The application process was straightforward and actually quite simple for a project with such a complexity. The communication and assistance from the side of the MIH network already in the process of the preparation of the required documents was very well done and the provided templates significantly facilitated the process. Early stage communication with potential partners in the preparation of the gate 1 assessment was very helpful for the process. The cooperation with the MIH required a high TRL level of the development for the entry into the discussions. Financial projections, market research and a detailed description of the project were necessary in order to show the potential for the development project.

Can you very briefly describe the problem you introduced to the Open Call and how the MIH members address it?

Our product aims to provide a PoC solution for the diagnosis of iron deficiency and iron deficiency anemia. The problem we introduced to the Open Call was the short comings of our current consumables. In particular the high variability of the background signal of the consumables in one of the detection schemes, varying strongly from production batch to production batch but also within a single production batch posed a challenge in reaching the full potential of the technology. Short comings with regard to the collected volume of the sample and the sample uptake by our current consumable were also addressed. In addition, the scalability of the manufacturing process was discussed to identify the most suitable production scheme within the targeted cost of goods.

The MIH members address these challenges by redeveloping the consumable into a microfluidic chip with optimized collection and sample handling properties providing an detection window for the multi-modal detection scheme. Concerning the variability of the background signal several different potential candidates of raw materials are currently being evaluated to identify an optimized material selection. With regards to the manufacturing technology different technologies were evaluated by the members of the MIH during the concept phase. It was agreed upon to start with an injection molding scheme able to meet the targeted production price but also to keep the doors open towards other technologies as roll-to-plate or roll-to-roll manufacturing in a continued collaboration.

What does the program specifically provide you, which you would not have achieved independently?

The program provides us with a single-entry point to a whole established network of partners combining all expertise and resources required for the development of a new and optimized consumable for our device. Our internal capabilities for such a development are limited and if not for the MIH we would have needed to form a collaboration with different companies at different stages of the project. In particular, the diverse set of fabrication technologies and the evaluation of the most suitable solution within the network significantly helped in the development. Additionally the partners involved in the network meet the requirements for ISO13485 needed for this development. This unique combination allows us to conduct the development within a reasonable timeframe without the need for managing contacts and projects with different companies.

The MIH introduced your problem to its 20 members whose capabilities and expertise cover the MFC valuechain, what is your view on accessing a wide diversity of services through a single entry point?

Entering a new field or starting a new development which is not envisioned to stop at the proof-of-concept level and which requires knowledge not or only partially available within your own team is always challenging. It normally requires to establish contacts with several partners at different stages of the development which can provide the needed expertise at that time, often requiring a transfer of knowledge between different partners. With this regard the MIH as the single entry point provided by the NGM consortium significantly reduces the hurdles to engage in such developments as the whole value chain is directly accessible and present during the whole process from the proof of concept phase to the transfer into production. As the modus operandi and all necessary agreements have already been established between the different partners the efforts on the side of the applicant are significantly reduced.

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

The current stage of the project is inline with the project plan and large progress has already been made. All partners are highly involved and the project management from all partners is excellent. Bi-weekly meetings have been established to communicate the progress and these meetings are always very well ordered and stick to the timeframe. In summary we are very happy with the status of the project.

What are your plans after the program, how will you utilize the results?

The results of the project will be utilized to take the next steps of bringing our PoC device to the market. In terms of product development the developed microfluidic chip will be used to optimize the performance of the analytical platform. With the completion of the development we can engage in establishing the manufacturing scheme with the partners from the MIH and taking all steps necessary as e.g. clinical trials to achieve ISO 13485 certification of our product. In addition we will use the results to evaluate the potential for the detection of further diagnostic markers forming the basis to extend the capabilities of our analytical platform.

What is your advice to other projects interested in applying for the Open Call?

It is a very good opportunity to perform projects where several partners with different expertises in the field of microfluidics are needed. The work and project management is well organized and executed. If one has a technology which has reached the required TRL and “just” needs a push on the side of the microfluidics, I can highly recommend to others to apply for the Open Call as it is a great opportunity to get 20 potential partners covering the diverse needs of developing a product and actually bringing it to the level of production.

DOWNLOAD the data sheet to find out more about the project:

Reference Case_BioAnalyt
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