What's Happening?
Labcorp, a prominent global laboratory services provider, has achieved a significant milestone by obtaining the IVDR CE-marking for its PGDx elio™ tissue complete test under the European Union's new In Vitro Diagnostic Regulation (IVDR). This test is the first of its kind in the EU to receive such approval for comprehensive solid tumor profiling. The CE-marking allows the test to be offered by more laboratories across the EU, thereby expanding access to personalized cancer care for the approximately 2.7 million people diagnosed with cancer annually in the region. The test, which has also been cleared by the U.S. Food and Drug Administration (FDA), enables the simultaneous analysis of multiple biomarkers, even with limited tissue samples, supporting physicians in delivering guideline-based care for patients with solid tumors.
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Why It's Important?
The IVDR CE-marking of Labcorp's PGDx elio™ tissue complete test represents a crucial advancement in precision medicine, particularly in the field of oncology. By facilitating earlier and more accurate diagnosis, the test can significantly impact patient management plans, potentially improving prognosis and treatment outcomes. This development is poised to benefit both patients and healthcare providers by reducing costs and accelerating the implementation of personalized treatment strategies. Furthermore, the test provides a reliable, regulatory-ready solution for biopharma partners, aiding in the de-risking of multiyear clinical trial strategies and ensuring continuity in next-generation sequencing (NGS) testing.
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 expansion aligns with Labcorp's mission to improve health and lives by advancing precision medicine. The company will continue to focus on enhancing patient access to personalized cancer care, potentially paving the way for similar advancements in other regions. Stakeholders in the healthcare and pharmaceutical industries are likely to monitor the rollout closely, as it could set new standards for cancer diagnostics and treatment.
