Shakti Ramkissoon: Labcorp Has Achieved IVDR CE Marking for PGDx elio Tissue Complete in the EU
Shakti Ramkissoon, VP and Head of Medicine, Product Development, and Delivery at Labcorp Oncology, shared a post on LinkedIn:
“Exciting news!
Labcorp has achieved IVDR CE marking for the PGDx elio tissue complete assay in the EU – this is a significant milestone that advances our mission to deliver high-quality, clinically validated genomic testing to more patients around the world.
IVDR (In Vitro Diagnostic Regulation) is the EU’s gold standard for diagnostic test performance, safety, and clinical utility, and this achievement reflects the dedication, scientific rigor, and cross-functional collaboration across our incredible teams.
Congratulations and thank you to everyone who made this possible.
Your work is expanding access to precision oncology across Europe and beyond.
Svetlana Nikic, Founder of Precision Oncology Consulting, shared this post, adding:
“As far as I’m aware, this is the first and only IVDR CE-marked assay for tissue comprehensive genomic profiling CGP in Europe.
It’ll be interesting to see how this will affect the CGP testing market and IVDR approval of similarly designed assays.
Thoughts?”
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