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been replaced by automated processes.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
torsten.haferlach@mll.com