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The genomics and diagnostics communities are keen to see clear implementation objectives set as the EHDS is rolled out over the next decade.
Mursla Bio, a Cambridge, UK-based company that focuses on EV isolation, biomarker discovery from EV cargo, and EV assays for clinical use, is an EVEREST participant.
Next Implementation Steps Unclear After EU Parliament Votes to Support IVD Regulation Review
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The parliamentary resolution drew the immediate support of MedTech Europe and VDGH, but it remains unclear what the immediate outcome of the resolution will be.
Two years after the IVDR started taking effect, changes to the regulations, including new deadlines, have meant continued uncertainty for firms and labs.
ESHG: Short-Read Genome Sequencing Boosts Rare Disease Diagnoses in European Solve-RD Project
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So far, 90 out of 836 or about 10 percent of families who were analyzed by short-read genome sequencing as part of Solve-RD have received a diagnosis.