The objective of the European Scientific foundation for Laboratory Hemato Oncology (ESLHO) is to promote innovation, standardization, quality control and education of laboratory diagnostics focused on lymphoid malignancies.
This objective is realized by:
- Supporting the organization of scientific meetings for the innovation/research, standardization and clinical validation of new tools, technologies and strategies for diagnosis of hematological malignancies and immune monitoring;
- Organizing educational sessions and symposia;
- Promoting the use of standardized protocols;
- Supporting the organization of quality control rounds for which a certificate of participation and performance is provided.
ESLHO supports three scientific consortia that implement these activities:
EuroClonality (www.EuroClonality.org), a consortium that facilitates continuous innovation, standardization, quality control and education of laboratory diagnostics with a focus on molecular clonality tests for the diagnosis and monitoring of hematological malignancies. EuroClonality developed and standardized novel multiplex PCR assays for detection of immunoglobulin (IG) and T-cell receptor (TR) gene rearrangements. These assays are now widely used for the diagnosis of lymphoproliferative disorders. The EuroClonality-NGS Working Group is a scientifically independent working group of EuroClonality with the aim to develop, standardize, and validate IG/TR NGS assays for clonality assessment, MRD analysis and repertoire analysis.
EuroFlow (www.EuroFlow.org), a consortium that develops and standardizes fast, accurate, and highly sensitive flow cytometric tests for diagnosis and prognostic (sub)classification of hematological malignancies as well as for evaluation of treatment effectiveness during follow-up. In addition to innovation, EuroFlow offers a number of services to improve the quality of diagnostics in the field of hemato-oncology worldwide, including Educational workshops, development of educational materials, organization of QA rounds and distribution of standardized protocols.
EuroMRD (www.EuroMRD.org), a consortium that develops guidelines for the interpretation of RQ-PCR MRD and NGS MRD data. These guidelines ensure identical interpretation of MRD data between different laboratories that use the same MRD-based clinical protocol. Furthermore, the EuroMRD guidelines facilitate the comparison of MRD data obtained with different treatment protocols, including those that evaluate new drugs, where MRD might be used as primary endpoint. EuroMRD organizes a quality control program on quantitative MRD diagnostics for lymphoid malignancies twice per year.
ESLHO was founded in Rotterdam, the Netherlands, in 2009, to provide support to the scientific consortia and to make their management more efficient. Until 2017, ESLHO acted as foundation on behalf of its three “sister” consortia EuroClonality, EuroMRD, and EuroFlow. To guarantee scientific and financial independence, the three consortia were transformed into individual foundations in 2017. The aims of the foundations remain the same: research & innovation of diagnostic patient care, standardization of laboratory diagnostics, quality assessment and continuous education. The ESLHO foundation now acts as “umbrella” organization, providing support for e.g. legal and financial aspects, intellectual property management and organization of meetings.
To maintain approval from all participating institutes and thus to be able to continue the collaboration within the foundations, a good governance strategy was implemented from 2018 onwards. This mainly concerns actions to make the foundations more transparent, including making detailed descriptions of all activities in the format of Workpackages, clarity about how royalty income is spent, and improving public visibility through new websites.
In May 2017, the new in vitro diagnostic medical device regulation (IVDR; Regulation (EU) 2017/746), which will regulate the EU internal market for in vitro diagnostic medical devices (IVDs), entered into force. Under the IVDR, more clinical evidence is required, both for CE marked IVDs (CE-IVDs) and for in-house devices (IH-IVDs). The unique collaboration within the ESLHO networks will be of benefit for establishing IH-IVDs, as such assays validated in a collaborative effort can be manufactured and used by all contributors. Furthermore, this gives them a strong position for collaborating with companies that wish to validate their IVDs. More information about the IVDR can be found on the IVDR web page of the ESLHO website.