Labcorp Holdings Inc., a leading provider of comprehensive laboratory services, announced that its PGDx elio™ tissue complete has achieved IVDR CE-marking under the European Union's new In Vitro Diagnostic Regulation (IVDR). This marks it as the first and only test of its kind in the EU to be CE-marked for comprehensive solid tumor profiling. The approval is a significant milestone, expanding access to personalized cancer care for approximately 2.7 million cancer patients annually in the EU. The test's ability to analyze multiple biomarkers with limited tissue samples supports physicians in delivering guideline-based care and accelerates patient management plans. This achievement not only reflects Labcorp's commitment to advancing precision medicine but also provides biopharma partners with a reliable solution for clinical trial strategies.
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