Digital Healthcare - Projects 2022

In cooperation with a hospital, Fraunhofer researchers have developed a technology that can determine far more quickly than previously whether a tumor has been completely removed, even while the patient is still in surgery. To achieve this, the consortium combined a compact laser scanning (LSC) microscope with fluorescent antibody-based tumor markers. This provides a way of telling immediately whether any cancer cells remain after the initial removal of the tumor. The detection process involves staining tissue outside the body with an antibody-based tumor marker and then examining it immediately at the critical tumor boundary using the LSC microscope.

From a technological point of view, a 2D microscanning mirror produced with MEMS (Micro-Electronic-Mechanical Systems) is used for this purpose. It oscillates several thousand times per second within the microscope, directing blue and red laser light simultaneously and point by point over the entire image field with a lateral resolution of one micrometer. The mirror simultaneously directs the fluorescent light emitted by the tissue towards highly sensitive photodetectors. The signals from the photodetectors can then be used to construct a two-dimensional image. The resolution and precision of the system is so high that even individual cancer cells can be detected and shown on the display. Thanks to a confocal principle, images can also be captured on different planes. While the device development was ongoing, an antibody-based, tumor-specific staining method was tested to enable fluorescence imaging for both brain and skin tumors. Put simply, this makes the cancer cells glow under the microscope. The consortium is continuing to test the system in the hospital setting. In future, the system is expected to be combinable with imaging supported by artificial intelligence and robotic implementation.

For the first time, a powerful yet portable LSC microscope has been developed as part of the LSC-Onco (Laser Scanning Oncology) project. The LSC microscope can be placed in the operating room right next to the person being treated. The technology was jointly developed by Helios Klinikum Erfurt and the Fraunhofer Center for Microelectronic and Optical Systems for Biomedicine MEOS.

Press release  »Cancer surgery«

A precise point-of-care (PoC) photonic platform is paving the way for a new generation of diagnostic systems. At the heart of the platform is an automatic readout device based on optical fiber microstructures. This guarantees highly accurate measurements and can analyze up to six photonic sensors simultaneously. In future, this will allow diseases such as tuberculosis or Q fever, which has been on the rise in Germany since 1995, to be detected and treated at an early stage.

Photonic sensor platforms are revolutionizing point-of-care diagnostic methods by providing high sensitivity, compactness and multiplexing capabilities for rapid and reliable detection of infectious diseases. For this newly developed innovative platform, an interdisciplinary consortium succeeded for the first time in combining photonic bottle microresonators made of glass fibers with a microfluidic system. The latter is required for transporting the test samples in the cartridge. The resulting optofluidic configuration in a chip cartridge is ideally suited for multichannel detection of target molecules in cell-based samples. For example, cytokines — proteins that play an important role in pathogens and the immune system — can be identified in less than 15 minutes. Other biomarkers for other infectious diseases can also be quantified in this brief period.

The new near-patient diagnostic system was developed as part of the “PoC-Bo-Sens” project funded by the German Federal Ministry of Education and Research (BMBF). The Fraunhofer Institute for Reliability and Microintegration IZM was responsible for coordinating an international consortium from the research fields of photonics, microfluidics, biochemistry, electronics and biomedicine. The next steps on the path to commercialization of the platform include upscaling of the optofluidic cartridge and readout unit, clinical verification, and validation for CE marking. 

Tech News »Point-of-care diagnostics for multiple diseases, courtesy of photonics technology«

Chimeric antigen receptor T-cell therapy (CAR T-cell therapy for short) is an innovative form of immunotherapy for treating cancer patients. In this form of treatment, genetic engineering is used to turn T lymphocytes taken from the patient into CAR-T cells. These cells’ receptors can detect specific antigens on the surface of degenerated cells and trigger a process that destroys them — independently of the immune system’s natural ability to differentiate between self and nonself, which cancer cells can often circumvent.

Researchers at the University Hospital of Würzburg have developed a special chimeric antigen receptor to detect the ROR1 molecule that is expressed by cancer cells in leukemia and breast and lung cancer. The genetic material for this special CAR is implanted in the T cells’ genome by means of a non-viral genetic process. This reprograms the T cells so that they identify the ROR1-positive cancer cells as “nonself” and destroy them. The Fraunhofer Institute for Cell Therapy and Immunology IZI produced many of the batches of CAR T-cell products for testing and validation. These products were used to optimize the demanding manufacturing process in line with pharmaceutical quality standards (good manufacturing practice, or GMP) and update the assortment list according to the German Medicinal Products Act (Arzneimittelgesetz, AMG). This resulted in an expansion of Fraunhofer IZI’s existing general manufacturing authorization for advanced therapy medicinal products (ATMPs). A preclinical study of the safety and effectiveness of ROR1 CAR T cells was also conducted at Fraunhofer IZI under the conditions laid down in Good Laboratory Practice (GLP) guidelines. This means that the team can now proceed to the next step, i.e., translating the treatment to the clinical domain by means of a phase I/II (first-in-human) study. The project was funded by the Proof-of-Concept initiative. This collaboration program was launched in 2017 by the Fraunhofer-Gesellschaft, the Helmholtz Association and the Deutsche Hochschulmedizin (umbrella organization for German university hospital associations). The goal of the initiative is to accelerate the translation of innovative research projects into practical medicine applications.

More about the research project

On behalf of the German government’s Commission of Experts for Research and Innovation (Expertenkommission Forschung und Innovation, EFI), the Fraunhofer Institute for Systems and Innovation Research ISI investigated how much progress has been made in the digitalization of the German healthcare system, and used its findings to recommend courses of action to further drive digital transformation in this area. The focus was on the implementation status of legally required initiatives, the position of the primary stakeholders, data protection and cybersecurity factors, and innovative business models. They also compared Germany’s progress with that of Denmark, Estonia, Spain and Austria.

The study identified a number of factors that are delaying Germany’s digital transformation, including conflicts of interest between the many stakeholder groups involved, especially bureaucratic groups, an inadequate digital infrastructure in healthcare facilities, security concerns, a lack of reliability as regards the technical solutions, and regulatory uncertainties. According to the results of the study, the legal initiatives from the previous legislative period have laid an important foundation for accelerating the digitalization of Germany’s healthcare system. The researchers also recommended additional policy initiatives and measures at the German federal state and government and EU levels — such as the expansion of a powerful broadband infrastructure, the development of an e-health strategy for Germany and a significant improvement in the IT security of healthcare facilities. However, keeping the public informed and increasing digital expertise among healthcare professionals should also be given high priority. The study’s comparison with other countries indicated that these countries had involved stakeholder groups to a greater extent in the early implementation stages of e-health processes. This approach can ensure that the implementation is more closely aligned with the actual needs of the healthcare sector, while also providing more support for the healthcare system’s digital transformation. The experts involved in the study have recommended that in order to support the digitalization of healthcare in Germany, the changes in question should be monitored continuously and tested through trials at living labs for e-health applications.