Why is the work of the cluster nanodiag BW so important?

Which objectives do we have? What benefits do our results open up?

The BMBF's high-tech strategy identifies health as one of the major global societal challenges. Groundbreaking findings from cutting-edge research show that epigenetic factors are causally involved in common and often fatal diseases, including cancers, diabetes, cardiovascular, mental, neurodegenerative and infectious diseases. These include the so-called post-translational modifications (PTM) of proteins. So far, these can only be detected with very complex mass spectrometry or with error-prone immunoassays. Recent research results show that miniaturized analysis systems based on nanopore technology will make it much easier, faster and more reliable to determine these modifications in the future - with the unique selling point that even isomers of the same mass can be differentiated. The nanodiag BW future cluster pursues the vision of realizing such miniaturized analytical devices and processes and transforming them into disruptive diagnostic products, innovative services and spin-offs with high growth potential. This will make epigenetic markers accessible to routine diagnostics and significantly improve the prevention, therapy and follow-up of common and severe diseases.

This is expected to make a significant contribution to improving the health of citizens in the coming years.

Example 1: Precaution. Epigenetic mechanisms are highly dynamic and depend on factors such as age, living conditions and lifestyle - in other words, on the individual "lifestyle" of each person. The advantage of detecting epigenetic markers over other testing strategies is that individual predispositions of patients can be determined at an early stage. In analogy to already established screenings, it would be conceivable in the future to determine the personal, lifestyle-related risk for diseases such as cancer, but also Alzheimer's, rheumatic diseases, diabetes or cardiovascular diseases via epigenetic factors and to derive corresponding behavioral recommendations.

nanodiag BW wants to create the conditions that make this possible.

Example 2: Therapy planning. Some cancer therapies, which can cause severe side effects, do not work in certain patient groups due to epigenetic changes in cellular signaling pathways. It would be highly beneficial to clearly identify these patients before starting therapy to avoid exposing them to unnecessary risks and burdens. With innovative analytical tools based on nanopore technology, the corresponding stratification (grouping) of patients on the basis of epigenetic markers would be possible quickly and reliably.

nanodiag BW wants to develop technologies that make this possible.

Example 3: Therapy monitoring. Epigenetic factors react quickly to therapies; in the negative case, this can lead to the formation of resistance in a very short time. Therefore, it is important to reliably detect these highly dynamic markers and to determine them during therapy.

nanodiag BW wants to develop devices that make this possible.

Example 4: Follow-up care. Recurrences or metastases can occur even many years after successful completion of cancer therapy. Conventional methods often detect these metastases too late; nanopore technology could detect characteristic epigenetic changes in proteins or nucleic acids in vesicles released into the blood by tumor cells as part of a less invasive and therefore higher frequency monitoring, so that life-saving measures can be initiated in time.

nanodiag BW wants to develop methods that make this possible.

Due to its high sensitivity, nanopore analytics in combination with new enrichment methods is particularly compatible with non- or minimally invasive sampling (liquid biopsy), so that no tissue sample needs to be taken for this purpose.

The market potential for the application of nanopore-based technologies and solutions results from the demand for corresponding devices for central laboratories, clinics, doctors' practices and possibly the home care sector, for intermediate products and consumables such as "test strips" as well as the associated services and processes. The global market volume for cancer diagnostics alone, for example, was reported to be approximately USD 170 billion in 2020 and will increase to USD 280 billion by 2028. At a constant growth rate (approx. 6% p.a.), a volume of 340 billion USD will be reached towards the end of the maximum cluster period. Experience with other disruptive technology developments, such as automated high-throughput electrophysiology by the project partner Nanion, shows that demand for new solutions is only created by the fact that they are technically realized and offered. In this respect, nanopore analytics in the field of medical diagnostics will create its own market to a large extent. It will help to avoid cost-intensive established diagnostics and unnecessary or harmful expensive therapy trials and thus contribute overall to increasing efficiency in the healthcare system.