What's Happening?
Labcorp, a global leader in laboratory services, has announced that its PGDx elio tissue complete test has received CE-marking under the European Union's new In Vitro Diagnostic Regulation (IVDR). This test is the first of its kind in the EU to be CE-marked for comprehensive solid tumor profiling, which is a significant milestone in personalized cancer care. The test, already cleared by the U.S. Food and Drug Administration (FDA), allows physicians to deliver guideline-based care for patients with solid tumors by analyzing multiple biomarkers from limited tissue samples. This advancement is expected to improve patient management plans and reduce delays in treatment, potentially impacting patient prognosis positively. The CE-marking enables more laboratories across the EU to offer this test, thereby expanding access to personalized cancer care for approximately 2.7 million people diagnosed with cancer annually in the EU.
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Why It's Important?
The CE-marking of Labcorp's PGDx elio tissue complete test under the EU's IVDR is crucial for advancing precision medicine and improving patient care. By enabling comprehensive solid tumor profiling, the test supports timely and effective patient management, which is vital for improving cancer treatment outcomes. This development also provides biopharma partners with a reliable solution for clinical trials, ensuring continuity in next-generation sequencing (NGS) testing beyond IVDR transition timelines. The expansion of this test across EU laboratories means more patients can access personalized cancer care, potentially leading to better health outcomes and reduced healthcare costs associated with delayed treatments.
What's Next?
Labcorp plans to make the CE-marked assay available for biopharma partners and for investigational use in global clinical trials through its central laboratory in Geneva, Switzerland. This move aligns with Labcorp's mission to improve health and lives by advancing precision medicine. As the test becomes more widely available, it is expected to lower costs, accelerate implementation, and help patients get tested sooner. The broader availability of this test may also prompt other laboratories to adopt similar technologies, further enhancing cancer care across Europe and potentially influencing global standards in cancer diagnostics.
