Highlights from the SWG
Until 2017, ESLHO has acted as foundation on behalf of its three “sister” consortia EuroClonality, EuroMRD, and EuroFlow. To guarantee scientific and financial independence, the three consortia have been 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 will act as “umbrella” organization, providing support for e.g. legal and financial aspects, intellectual property management, and organization of meetings.
To maintain approval from the boards and lawyers of all participating institutes and thus to be able to continue the collaboration within the foundations, we started to implement a good governance strategy in 2018. This mainly concerns actions to make the foundations more transparent, including detailed description of all activities in the format of Workpackages, clarity about how we spend the royalty income, and improving public visibility through new websites.
In May 2022, the new in vitro diagnostic medical device regulation (IVDR; Regulation 2017/746), which regulates the EU internal market for in vitro diagnostics, will come into effect. Under the IVDR, more clinical evidence is required, both for commercial IVDs (CE-IVDs) and for in-house devices (IH-IVDs). The unique collaboration within the foundations will be of benefit for establishing IH-IVDs, as such devices validated in a collaborative effort can be manufactured and used by all contributors. Furthermore, this gives the foundations a strong position for collaborating with companies that wish to validate their IVDs.
In addition to the IVDR, MRD diagnostics and immune monitoring have been important topics of the ESLHO Symposia in recent years, including the 10th ESLHO Symposium on Monitoring of immunotherapies: Basis for Companion Diagnostics? that took place on 11-12 November 2021 in CORPUS Congress Centre, Leiden, The Netherlands.