Pharma

Optimal diagnostics
for clinical research.

Overview
Clinical Lab Services

Medical and Scientific Affairs
Biomarker Research

MLL Dx GmbH in cooperation with the MLL Münchner Leukämielabor, served in a number of clinical trials as a diagnostic reference laboratory. We see ourselves as partners and diagnostic consultants to make a study clinically valuable as we have direct contact to the clinicians and know the needs of the daily clinic, treatments but also the requirements for clinical trial processing.

Overview

Clinical lab services

Comprehensive diagnostic portfolio, e.g.

Polymerase chain reaction-based methods (qPCR, dPCR, RT-PCR, Fragment length analysis)
Next-generation sequencing (NGS): targeted Panel, Whole-exome sequencing (WES), Whole-genome sequencing (WGS), Whole-transcriptome sequencing (WTS)
10 color flow cytometry
Cytogenetics (G-banding)
Fluorescence in situ hybridization (FISH)
Chromosome painting, incl. 24 color FISH
Cytomorphology
Cytochemistry
Magnetic-activated cell sorting, CD138 (MACS)
Cell sorting
Single Cell Sequencing (10X Genomics certified service provider)
Sample Storage
Assay Development and qualification

State-of-the art methods in Cytogenetics, FISH,Cytomorphology, Immunophenotyping and Molecular Genetics
24/7/365 service available
Clinical reports can be issued if required
MRD
Scalable workflows for all offered methods
Assessing diagnostic inclusion criteria
Sample storage systems (RT, 4°C, -20°C, -80°C, -160°C, viable cells) for subsequent analysis
World-class NGS analyses (targeted Panel, WGS, WES, WTS) incl. bioinformatic result interpretation
AI to integrate available information in one comprehensive analysis

State-of-the art methods in Cytogenetics, FISH,Cytomorphology, Immunophenotyping and Molecular Genetics, MRD
24/7/365 service available
Scalable workflows for all offered methods
Short TATs can be adopted to clinical needs
Clinical reporting in English available
Experienced in processing international routine samples
Clinical reports meet all requirements of current guidelines and recommendations
ISO 15189 and ISO 17025, CAP accreditation, 21 CFR part 11 compliant

Samples in clinical trials at MLL

Number of samples per diagnostic method since 2005. Sum: 51,856 analyses for 22,489 samples; 2.3 methods per sample.

Medical and scientific affairs

Publications

Our goal is to make the knowledge we gain in our daily routine diagnostics and in scientific projects available to physicians and scientists. In recent years, we have authored and published more than 600 publications.

Publications

MLL Academy

A 3-days workshop at MLL in Munich:

Respective MLL-experts for each topic as presenters
Practical and theoretical interactive sessions
All lectures held in modern MLL seminar rooms
Practical demonstrations and trainings in optimally equipped MLL laboratories
Variety of hemato-oncological entities and latest technical developments covered

MLL experts to support developing an overarching clinical diagnostics plan allowing biomarker-analyses across different clinical development phases and comparison of different leukemia/lymphoma entities
MLL experts supports designing the most efficient diagnostics in clinical trials – tailored design for each clinical study/phase
MLL experts to advise in all laboratory-related matters, e.g. appropriate technologies, test menus, biomarkers, optimal sampling time points, required sample types, MRD

Suggest, arrange and conduct EQAs or ring studies, incl. provision of appropriate and sufficient samples and the review of participants results
Evaluate current diagnostic performance and provide helpful feedback to labs
Perform webinars or workshops to educate labs/physicians on appropriate sample testing (on-site and/or virtual)
Support labs in validating assays (on-site and/or virtual)
Provide test samples (positive and negative controls)
On-site lab visits to improve diagnostic workflows and ensure high quality diagnostics

Biomarker Research

Biomarker analysis, incl. standard diagnostic workup according to current guidelines and recommendations
Anonymized routine diagnostic data readily available from over 700k hemato-oncology patients
About 5k patient samples with matched WGS and WTS data available
Diagnosis vs MRD
Next-generation Sequencing: targeted Panel, WES, WGS, WTS
Integration of different methods (Cytogenetics, FISH, Cytomorphology, Immunophenotyping and Molecular Genetics) to distinguish patient groups and to apply current classification and prognostication systems
AI to develop evidence-based clinical trial test-algorithms

Biomarker analysis, incl. standard diagnostic workup according to current guidelines and recommendations
Anonymized routine diagnostic data readily available from over 700k hemato-oncology patients
About 5k patient samples with matched WGS and WTS data available
Diagnosis vs MRD
Next-generation sequencing: targeted Panel, WES, WGS, WTS
AI to identify alterations predicting treatment response
Screen other hematological entities for similar/identical alterations
Design of diagnosis-independent biomarker-based studies

For us, the focus is on research to further develop diagnostics and therapeutic options for leukemia patients. Through both in-house research and worldwide collaborations, we strive to advance and support research and knowledge.

Research

You may also be interested in

Career

As a rapidly growing, innovative medical laboratory, we are always looking for bright minds to help us bring new and more effective therapies to patients around the world.

Learn more

Services

Do you have questions about sample submission, analyses performed or findings? Here you will find contact details, contact persons and our most frequently asked questions (FAQs).

Learn more

Quality management

We have been certified according to national and international standards since 2009 and have successfully maintained these accreditations.

Learn more