Labcorp Achieves IVDR CE-Marking for PGDx elio™ tissue complete in the EU

Core Insights - Labcorp has received CE-marking for PGDx elio™ tissue complete, making it the first and only test of its kind in the EU for comprehensive solid tumor profiling, significantly enhancing access to personalized cancer care for approximately 2.7 million cancer patients annually in the EU [1][2] Group 1: Product and Regulatory Approval - The PGDx elio™ tissue complete test has been cleared by the U.S. FDA and is now CE-marked under the EU's new In Vitro Diagnostic Regulation (IVDR), supporting guideline-based care for patients with solid tumors [2][3] - The test can analyze multiple biomarkers simultaneously, even from limited tissue samples, which can expedite patient management plans and potentially improve prognoses [2][3] Group 2: Impact on Healthcare and Biopharma - This achievement reflects Labcorp's commitment to advancing precision medicine and improving patient care, setting a new standard for quality and performance in cancer diagnostics [3] - The CE-marking allows for broader laboratory access across the EU, facilitating personalized cancer care and providing biopharma partners with a reliable solution for clinical trials [3][4] Group 3: Company Overview - Labcorp is a global leader in laboratory services, supporting healthcare providers and pharmaceutical companies with diagnostics and drug development, performing over 700 million tests annually [6]