Labcorp , a global leader in innovative laboratory diagnostics, announced that PGDx elio™ tissue complete has received CE marking under the European Union’s new In Vitro Diagnostic Regulation (IVDR). It is now the first and only test of its kind in the EU to be CE-marked for comprehensive solid tumor profiling, marking a pivotal step forward in broadening access to personalized oncology care for the estimated 2.7 million people diagnosed with cancer annually in the EU.
Already cleared by the U.S. Food and Drug Administration (FDA), this in vitro diagnostic (IVD) assay empowers clinicians to deliver guideline-driven care for patients with solid tumors. Its ability to analyze multiple biomarkers from limited tissue samples provides critical insights that can inform timely and effective treatment strategies—potentially avoiding delays that can adversely impact patient outcomes.
With CE-marking now in place, more laboratories across the EU can adopt this advanced assay, expanding patient access to precision cancer testing.
"This milestone reinforces Labcorp’s commitment to advancing precision medicine and transforming patient care," said Dr. Shakti Ramkissoon, Vice President and Medical Lead for Oncology at Labcorp. "With dual FDA and IVDR CE-mark approvals, the test sets a new benchmark for quality and reliability in cancer diagnostics. It also offers our biopharma partners a trusted, regulatory-ready platform that supports long-term clinical trial strategies—especially important during the IVDR transition."
Designed for flexibility, PGDx elio™ tissue complete allows laboratories to perform testing in-house, reducing costs, speeding implementation, and ultimately helping patients get tested and treated faster.
Labcorp plans to offer the CE-marked assay for biopharma partners and for investigational use in global clinical trials via its central laboratory in Geneva, Switzerland. This development underscores Labcorp’s ongoing mission to improve health and lives by advancing accessible, personalized cancer diagnostics throughout Europe and beyond.