Responsible change in hematological diagnostics, therapy, and research:

The MLL MVZ Annual Review 2025

December 16, 2025

Infrastructure and services: shortening distances, securing processes

This ambition was particularly evident in the new, highly automated sample reception area at the MLL MVZ. With its completion in spring 2025, we reorganized the core of our daily operations. Samples are now registered, sorted, and transferred to the diagnostic areas faster than ever. Every step is digitally traceable, and many manual tasks have been replaced by automated processes. This increases not only speed and capacity but also, above all, process reliability, giving our teams more time for tasks that require their experience and diagnostic judgment.

Another component is the sample transport service, which we expanded in 2025. Around 220 participating practices and clinics have now been connected step by step, and 50% of all incoming samples are transported in this way. This service picks up samples from these facilities on site and delivers them to us by 7:00 a.m. the next day. For our partners, this means reliable time slots for collection and delivery, clear contact persons, and greater planning security for everyday care. Thus, the service is growing in the intended direction: closer to the needs of our colleagues and patients, embedded in regional care structures, and poised to reach more locations in the medium term.

At the same time, we have refined our digital communication channels. With the more comprehensive establishment of KIM-Mail – communication in the medical sector – findings and documents can now be integrated directly into our senders' systems via a standardized, secure channel. KIM is thus a further step toward truly networked care, in which information no longer fails at system boundaries but arrives where it is needed for care.

New diagnostic milestones and findings: precision in depth

In addition to improving pathways and processes, 2025 saw the introduction of a wide range of new and enhanced diagnostic services. These services share a common goal: enabling more precise statements about disease risks, progression, and treatment options.

One focus was on patients with clonal cytopenias. We implemented a new risk prediction score in the diagnostic process to help assess patients more accurately, identify progression risks more effectively, and plan check-ups and therapeutic decisions more efficiently. We were also able to refine the prognosis models for myelodysplastic neoplasms. A new study shows that the size of the genetic clone – i.e., the proportion of diseased cells in the bone marrow, which has often been neglected in the past—provides important additional information on disease progression, response to therapy, and survival in myelodysplastic neoplasms.

We have expanded molecular monitoring further in the field of acute myeloid leukemia (AML). Standardized MRD diagnostic strategies (in accordance with the new ELN guidelines published in December), the integration of new markers, and the systematic evaluation of progression data are helping align treatment pathways more closely with individual disease dynamics, from initial diagnosis to follow-up care.

At the same time, we have expanded our diagnostic offerings to include personalized therapies. For example, we now offer a new UGT1A1 genotyping assay. This assay plays an important role in diagnosing Meulengracht disease and in pharmacogenetics for drug-induced toxicity, such as with irinotecan and nilotinib. The inclusion of such pharmacogenetic issues in our portfolio demonstrates the breadth of modern hematological diagnostics.

Last but certainly not least, we pay special attention to rare or complex cases. We offer examination methods that go beyond all standard requirements. Special staining and analyses, as well as interdisciplinary case conferences, demonstrate that diagnostic excellence is necessary where routine methods are insufficient. We combine highly standardized processes with an individualized approach for each patient.

Another step in this direction was the launch of our whole-genome sequencing study on rare anemias. Our goal is to use comprehensive genome data to more quickly and reliably identify the genetic cause of previously unexplained anemias. Here, research and care are directly interlinked: the findings should shorten future diagnostic pathways and give treating physicians more confidence when caring for these patient groups.

The dispatch of our three millionth medical report since our founding in 2005, as well as the one million samples processed in molecular genetics to date, highlight the close link between continuity and innovation in our laboratory's daily operations.

Research and scientific presence: exchange on many stages

The fact that diagnostics always involves research was demonstrated once again in 2025 at several scientific events in which the MLL MVZ was involved as an organizer, host, speaker, or contributor of award-winning work.

The 21st ELN and 24th KNL Symposium kicked things off at the end of February. The focus was on current developments in leukemia research, including MRD, NGS, and cytogenetic issues such as complex karyotypes and CHIP (clonal hematopoiesis with indeterminate potential). For us, the ELN is and will continue to be an important platform for presenting our data and discussing the development of guidelines and diagnostic standards with the community.

Just a few weeks later, in March, the fourth ESH conference, "How to Diagnose and Treat: CML/MPN," took place in Vienna. The conference covered a wide range of topics, including new treatment options, registry data, and the potential role of artificial intelligence in diagnosing and assessing the progression of chronic myeloid leukemia (CML) and myeloproliferative neoplasms (MPN). The audience showed great interest in our contributions on the opportunities, limitations, and practical application scenarios of AI in hematology.

From May 7 to 9, 2025, we attended the 38th International Symposium on Technological Innovations in Laboratory Hematology (ISLH) in Halifax. The symposium focused on technological innovations in laboratory hematology, automation, and AI applications. We were especially pleased that Dr. Dr. Armin P. Piehler received the Carol Briggs Top Scoring Abstract Award for his machine learning–based thalassemia prediction work. This award highlights the potential of combining routine data, modern statistics, and AI methods, as well as their effectiveness in practice.

In June, members of the international hematology community gathered for the European Hematology Association (EHA) Congress in Milan. The focus was on new developments in AML MRD diagnostics, guideline issues, and the role of artificial intelligence in morphology, among other things. The EHA Congress once again provided us with an important platform to present our projects, such as the automated analysis of myeloid precursor cells, and to contribute to the dialogue on future standards in hematological diagnostics.

In early July, we held the INSTAND training course, "Modern Diagnostics of Leukemia and Lymphoma," in Munich. Over the course of two intensive days, we discussed key procedures ranging from cytomorphology and immunophenotyping to molecular genetics, and we brought them to life in laboratory tours.

As part of the Medical Faculty PhD Program at the Technical University of Munich, doctoral students enrolled in the PhD Lab course, "Hematologic Malignancies," were able to gain insights into our work, carry out practical exercises, and discuss current topics, such as integrated findings, genome sequencing, and AI in diagnostics, with our teams over a period of five days. This course is offered every semester at TUM.

The scientific exchange continued seamlessly in the fall. From October 24 to 27, the annual meeting of the German, Austrian, and Swiss Societies for Hematology and Medical Oncology (DGHO) took place in Cologne. The focus was on new findings regarding AML, CLL, myeloproliferative neoplasms, and MRD diagnostics. We were especially delighted to see Dr. Veronika Ecker receive an award for her poster on the combined genetic and phenotypic analysis of NPM1-mutated AML. This prize exemplifies the close connection between immunophenotyping and molecular genetics at the MLL MVZ.

From October 13 to 16, the 47th Annual Meeting of the International Society of Oncology and Biomarkers (ISOBM) was held in Murnau. The meeting was dominated by an international perspective on oncology diagnostics. With the theme "A New Era of Biomarkers in Oncology," participants discussed opportunities and limitations of AI in diagnostics, the importance of minimal residual disease (MRD) as a therapy parameter, translational biomarker research, and standardization in laboratory medicine. Our contributions emphasized our dedication to consistent, standardized MRD concepts and evidence-based biomarkers.

2025 was a significant year for the international cytometry community. At the International Clinical Cytometry Society Meeting & Course (ICCS 2025), we shared our insights on the regulatory and technical challenges of clinical flow cytometry. Topics ranged from quality control and handling laboratory developed tests (LDTs) to further developing technical standards. The election of Prof. Wolfgang Kern as ICCS president also impressively recognized the MLL MVZ's role in international cytometry.

Our expertise was in demand once again on the American continent. From December 6 to 9, at the ASH Annual Meeting and Exposition in Orlando, we presented on new approaches to detecting clonal evolution in circulating tumor DNA, translating ctDNA MRD concepts into the treatment of B-cell lymphomas, and biallelic TET2 changes in NPM1-mutated AML, among other topics. Other topics included MRD diagnostics based on phenotype and genotype using flow cytometry.

Looking to the Future: MLL, MVZ, Innovation Summit, Genome Network, and more

Our own formats played a central role. The MLL MVZ Innovation Summit, held on November 10 and 11, brought together leading scientists and industry experts at our premises. Topics discussed included single-cell DNA methylation, long-read sequencing, and innovative omics approaches, as well as practical application scenarios and collaborations with industry partners. At the end of November, we held the continuing education event, "The Diagnostic View Into the Microscope: Hematology in the Context of Clinical Practice, Diagnostics, and Therapy," which combined cytomorphology, immunophenotyping, and molecular genetics in a CME-certified course.

One important future initiative is the Hematology Genome Network, which we established and that held several working meetings in 2025. The focus was on current projects in genomic medicine and joint projects for the coming years. The network aims to integrate research project and patient care data to generate personalized knowledge-based care, from efficient next-generation sequencing to whole-genome sequencing. Discussions revealed that examining entire genomes is a critical area for the future of diagnostics and therapy, both nationally and internationally. As MLL MVZ, we actively support these approaches and are committed to ensuring that genomic diagnostics are recognized as viable innovations in the healthcare system and are further integrated.

Quality, accreditations, and other awards

All these activities are based on a consistent understanding of quality. In 2025, in addition to our DAkkS accreditation, our College of American Pathologists (CAP) accreditation was reconfirmed. This certification verifies our compliance with the highest international quality and safety standards, ensuring the reliability and reproducibility of our results. This accreditation is both an obligation and a door opener for us. It enables us to participate in international research collaborations, clinical trials, and pharmaceutical partnerships, and it makes the quality of our work comparable worldwide.

Our company has also received recognition. We maintained our position in the TOP 100 innovation competition for the seventh consecutive year, and we were recognized as one of the 100 most innovative medium-sized companies in Germany by the Wirtschafts Woche ranking, "Innovation Champions 2025." Such awards are, for us, above all an expression of the joint achievement of all our employees — from the sample reception teams to the specialist departments, IT, administration, and organization.

Our managing director is Prof. Torsten Haferlach and Prof. Wolfgang Kern, received special recognition when they were appointed top reviewers for the journal Leukemia (Nature Publishing Group). Their work on review boards ensures that new research results are evaluated at the highest level and impact the international community. This is an additional contribution to scientific quality that often goes unnoticed outside of everyday laboratory routines.

Togetherness, young talent, and commitment: Focusing on people

2025 was a year of major professional projects and togetherness. To celebrate the company's 20th anniversary, we took two large group trips in the summer. In July and August, around 100 colleagues each set off for Dresden for two nights. A boat trip on the Elbe, cultural highlights ranging from the Zwinger to the Frauenkirche, and an evening together at the Kurländer Palais set the stage for conversations, connections, and a strong sense of community. These days demonstrated the importance of personal connections and shared experiences for an organization that often deals with complex, abstract issues.

In 2025, we were interested in promoting young talent in the medical technology sector. We welcomed several classes from vocational schools specializing in medical technology and laboratory analysis, including those from Bayreuth, Augsburg, Munich, and Kempten. The students gained insights into cytomorphology, chromosome analysis, fluorescence in situ hybridization (FISH), molecular genetics, and immunophenotyping. They also observed our MTL staff and asked questions about training, career paths, and everyday work. For us, these introductory days are much more than a behind-the-scenes look: They are an investment in tomorrow's skilled workers and an expression of our commitment to training and knowledge.

In collaboration with BioM and the Biomedical Center Munich, we participated in the Biotech & Pharma Career Day at the beginning of October. This event provided us with an important opportunity to speak with potential applicants and share insights about the daily operations of a specialized hematology laboratory.

We have further strengthened our commitment to the DKMS. As a diagnostic partner, supporter of research projects, and promoter of awareness about stem cell donations, our contributions go beyond the traditional role of a laboratory. A highlight this year was the visit from the DKMS Group, including representatives from global management and the life science laboratory. Our joint discussion focused on new perspectives on diagnostics, data quality, automation, scalability, and personalized medicine, always with the common goal of helping patients worldwide faster and more precisely. Such encounters demonstrate that scientific excellence, technological innovation, and human commitment must work together to enable real change. Additionally, we held a comprehensive registration day for our employees at the MLL MVZ.

Last but certainly not least, our open house in the fall provided over 200 participants with the opportunity to experience the laboratory "from the inside" for family and friends of our employees. Tours of all diagnostic areas, insights into robotics and automated microscopy, and discussions with our teams showed how much passion and precision goes into each sample.

Digitalization, AI, and health policy: Our stance in turbulent times

In several articles, we have once again addressed the future of healthcare and the role of digitalization and artificial intelligence in 2025. Our core concern remains unchanged. AI and digital technologies are not an end in themselves. They only demonstrate their value when they improve care, relieve doctors, and provide patients with greater security. This conviction that responsibility for decisions remains with humans runs through all our projects.

At the same time, we recognize the structural deficits plaguing the German healthcare system: regional disparities, cumbersome administrative processes, and a lack of interoperability. In this context, we strive to be a constructive voice. We identify areas where digital infrastructure, including KIM, diagnostic portals, and AI-supported analysis systems, creates real added value. Additionally, we advocate for conditions that foster innovation while safeguarding sensitive data.

Since mid-2022, we have supported the Help for Ukrainian Hematology Patients (HUP) network. Founded immediately after Russia's invasion of Ukraine, HUP ensures hematological care in the country. Backed by the WHO, ASH, EHA, and local and international partners, the network promotes establishing stem cell transplantation programs and expanding hematological diagnostics with the help of telemedicine and international cooperation. Since the initiative began, the MLL MVZ has analyzed over 3,400 Ukrainian patient samples in around 14,200 tests and sent over 13,000 findings back to Ukraine. We provide these results to our Ukrainian partners free of charge and in a timely manner. 

Thanks and outlook

We don't only focus on the long-term dimension of our work on World Cancer Research Day in September. Since 2005, we have examined more than 1.3 million samples, employed over 390 people, used more than 1,000 high-performance devices, and published over 870 peer-reviewed articles (55 new in 2025), continuously contributing to research into hematological diseases. Each sample, study, and publication brings us closer to achieving our goal of better understanding cancer and using therapies more effectively.

Looking back on 2025, we see a year in which performance, innovative strength, scientific presence, and human proximity came together in a special way at MLL MVZ. We implemented a new automated sample reception system that elevated our processes. We expanded our diagnostic services to further enhance precision and personalization. We hosted international conferences, summits, and courses where knowledge was shared and new ideas were born. We dedicated resources to expanding our AI, research, and innovation departments. And last but not least, we have a strong team that makes all of this possible every day.

So, first off, we wanna say a big thank you to all our MLL MVZ employees, our senders, our cooperation partners, sponsors, and patients. Your trust is the foundation of what we do, and we're grateful for your support. Thanks to this support, we are confidently looking forward to 2026. Our goals are to further expand our diagnostic excellence, strengthen our services, advance research and innovation, and responsibly exploit the opportunities offered by digital medicine.

Because we work from the perspective that every sample submitted represents a person and their life story.

The author

»Do you have any questions? Feel free to contact us!«

Prof. Dr. med. Dr. phil. Torsten Haferlach

Executive Management
Internist, Hematologist and Oncologist

T: +49 89 99017-100

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