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Labcorp Achieves IVDR CE-Marking for PGDx elio™ tissue complete in the EU
Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, announced today PGDx elio™ tissue complete has been CE-marked under the European Union's (EU) new In Vitro Diagnostic Regulation (IVDR). It is now the first and only test of its kind in the EU CE-marked for comprehensive solid tumor profiling. This marks a significant milestone in expanding access to personalized treatment options for the approximately 2.7 million people diagnosed with cancer every year in t
About this update from Labcorp Holdings Inc.
[{"type":"text","content":"First-and-only test of its kind approved under new European Union regulations expands access to personalized cancer care for patients across the EU","length":147,"tagName":"p","attribs":{}},{"type":"text","content":"BURLINGTON, N.C., July 29, 2025 /PRNewswire/ -- Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, announced today PGDx elio™ tissue complete has been CE-marked under the European Union's (EU) new In Vitro Diagnostic Regulation (IVDR). It is now the first and only test of its kind in the EU CE-marked for comprehensive solid tumor profiling. This marks a significant milestone in expanding access to personalized treatment options for the approximately 2.7 million people diagnosed with cancer every year in the EU.","length":573,"tagName":"p"},{"type":"image","alt":"Labcorp Logo (PRNewsfoto/Labcorp)","displaySize":"","headline":null,"caption":"Labcorp Logo (PRNewsfoto/Labcorp)","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":107,"url":"https://media.zenfs.com/en/prnewswire.com/dfb2a169dcf74a375ce32bd7ba958549"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/Cr5Hwp2W1WfQXLeh2BBTbQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTE4OTtjZj13ZWJw/https://media.zenfs.com/en/prnewswire.com/dfb2a169dcf74a375ce32bd7ba958549","width":400,"height":107}},"href":"https://mma.prnewswire.com/media/2044800/Labcorp_Logo.html","hrefExternal":true,"rel":"nofollow"},{"type":"text","content":"This in vitro diagnostic (IVD) assay, which has been cleared by the U.S. Food and Drug Administration (FDA), supports physicians in delivering guideline-based care for patients with solid tumors. Its ability to simultaneously analyze multiple biomarkers, even with limited tissue samples, enables insights that can support patient care and clinical management. For many, this could mean the difference between starting an effective patient management plan sooner or facing delays that could impact their prognosis. With this CE-marking, the test can now be offered by more laboratories across the EU, expanding patient access to personalized cancer care.","length":654,"tagName":"p"},{"type":"text","content":""This accomplishment reflects Labcorp's commitment to advancing precision medicine and improving patient care," said Shakti Ramkissoon, M.D., Ph.D., MBA, vic...