DIANA: Alliance for innovative point-of-care tests

To improve local medical care through point-of-care tests (PoCT), 80 partners from industry and research in Saxony and Thuringia have joined forces to form the DIANA (Diagnostics and Sustainability) alliance. Dr. Dirk Kuhlmeier coordinates the alliance.

In an interview with MEDICA-tradefair.com, he talks about the collaboration and its goals and opportunities for partners in the network.

Dr. Kuhlmeier, what has happened since funding began in 2021?

Dr. Dirk Kuhlmeier: The long-term goal of our regional funding is to improve healthcare. To this end, almost eight million euros have been allocated to companies and research institutions so far, which have contributed to the development of technological expertise. We are now writing the concept for the second funding period of the Federal Ministry of Education and Research (BMBF) and hope to receive a further seven million euros for our partner organizations. We have been able to use the funding to support numerous point-of-care diagnostics projects. For example, the development of environmentally friendly, high-quality paper-based diagnostics that are inexpensive and sustainable. Think of the billions of plastic cases that ended up in the trash after a single use during the coronavirus pandemic.

Another focus of our work is improved sample preparation, which varies depending on the sample. The range of samples can be relatively broad. This means that even inexperienced users can use on-site diagnostics, even if they have no experience with specific sample preparation. The analysis is then always carried out immediately in a cartridge, a kind of black box. But for the different types of samples such as blood, saliva or urine, modules must be available that explicitly accommodate one type of sample.

What are the goals of the alliance?

Kuhlmeier: Our aim is to be able to map the entire value chain in diagnostics here in the region with this funding. For example, an injection molding company should also be able to manufacture medical products after the project. This concerns technical issues, but also regulatory requirements. Now, funding is limited to the region. We can also accept partners from other regions for projects, but we want to remain rooted in the region.

We want to create a strong regional network for diagnostics. After the funding period, we can expand the regional bracket to become better known as "Diagnostic Valley".

What are the areas of application of the technologies, current projects and research questions?

Kuhlmeier: For us, point-of-care diagnostics is at the center of our activities. Even those partners who have had nothing to do with medical diagnostics or general medical issues to date should learn and understand what special requirements there are in the area of manufacturing, packaging and approval of medical products.

The PlasmaSepPOC project is a good example. It involves the separation of blood plasma from whole blood samples for the detection of biomarkers. Current methods for obtaining plasma from whole blood are often time-consuming, expensive and not suitable for mass production in point-of-care systems. PlasmaSepPOC combines expertise from the disciplines of microfluidics, materials technology and diagnostic technology for a future PoC solution.

If we anchor such a basic project here in the region, we can later transfer what we have learned to other projects.

What are the challenges for the industry?

Kuhlmeier: These are the regulatory aspects, but also communicating the special requirements in the manufacture of medical products, for example the hygienic conditions in production. Miniaturization and working with microstructures are also challenging. The choice of materials is also important to us to move away from petroleum-based products.

What are the advantages for members of the network, researchers and companies?

Kuhlmeier: From our point of view, the projects must be as interlinked as possible. We do not want stand-alone projects, but rather a build-up of expertise in the region that leads to the companies being fit for further projects of this kind. The region should establish itself as a diagnostics region that has both development and manufacturing expertise and thus has a pull effect for other companies in the diagnostics market.