Labcorp Earns IVDR CE-Marking for PGDx elio™ tissue complete, Paving the Way for Expanded Personalized Oncology Testing Across Europe
In a milestone achievement that advances the accessibility of precision oncology in Europe, Labcorp (NYSE: LH), a global leader in comprehensive laboratory services and diagnostics, has announced that its next-generation sequencing (NGS) assay, PGDx elio™ tissue complete, has received CE-marking under the European Union’s (EU) In Vitro Diagnostic Regulation (IVDR). This regulatory clearance positions PGDx elio™ tissue complete as the first and only test of its kind in the EU CE-marked for comprehensive genomic profiling of solid tumors, marking a significant step forward for cancer diagnostics and personalized medicine in the region.
The IVDR CE-mark certification validates the test’s compliance with the EU’s stringent regulatory framework, which governs the safety, performance, and reliability of in vitro diagnostic medical devices. Labcorp’s achievement not only affirms the assay’s clinical utility and analytical robustness but also opens the door for its broader adoption by clinical laboratories and healthcare providers across the EU, potentially transforming care pathways for millions of cancer patients.
Addressing a Critical Clinical Need in Oncology
Every year, approximately 2.7 million people in the EU are diagnosed with cancer, with solid tumors representing the majority of these cases. In the evolving landscape of oncology, genomic profiling has become a vital component of modern cancer care, allowing physicians to tailor treatments based on the molecular characteristics of each patient’s tumor. However, the accessibility of high-quality, validated NGS-based diagnostic tests has remained a challenge in many healthcare systems—especially under the regulatory transition from the previous In Vitro Diagnostic Directive (IVDD) to the new IVDR framework.
PGDx elio tissue complete, which has already received clearance from the U.S. Food and Drug Administration (FDA), now becomes the first CE-marked assay under the new IVDR for pan-solid tumor profiling. This NGS-based IVD assay can simultaneously assess multiple genomic biomarkers from limited tissue samples, making it an indispensable tool for oncologists aiming to align patient treatment plans with clinical guidelines and the latest evidence-based therapies.
According to Dr. Shakti Ramkissoon, M.D., Ph.D., MBA, vice president and medical lead for oncology at Labcorp, the regulatory milestone represents more than just a formal approval—it signals a turning point for molecular diagnostics in Europe.
“This accomplishment reflects Labcorp’s commitment to advancing precision medicine and improving patient care,” said Dr. Ramkissoon. “With both FDA clearance and IVDR CE-mark, this test sets a new standard for quality and performance in cancer diagnostics. Importantly, it also provides our biopharma partners with a reliable, regulatory-ready solution to de-risk multiyear clinical trial strategies, ensuring continuity in NGS testing for trials that will extend beyond the IVDR transition timelines.”
A Versatile Platform Designed to Expand Access and Accelerate Care
One of the primary challenges faced by healthcare systems worldwide is how to integrate complex genomic technologies into clinical workflows without creating additional cost or logistical barriers. Labcorp’s PGDx elio tissue complete offers a streamlined solution for laboratories seeking to build in-house NGS capabilities while maintaining compliance with international regulatory standards.
By leveraging its standardized assay design, automation-ready workflow, and scalable deployment model, PGDx elio tissue complete simplifies implementation for pathology and molecular diagnostics labs. This, in turn, helps reduce turnaround time and cost, enabling faster delivery of actionable results for oncologists and their patients.
More importantly, the assay’s ability to maximize insights from limited tumor tissue is especially beneficial for patients where biopsy samples are scarce or difficult to obtain. These advantages can translate directly into earlier therapeutic decision-making, avoiding treatment delays that might compromise patient outcomes.
For cancer patients in the EU, particularly those who live in regions with limited access to centralized molecular testing services, the availability of CE-marked PGDx elio tissue complete could significantly improve the timeliness and personalization of their care.
Supporting Drug Development and Global Clinical Trials
In addition to its role in patient diagnostics, PGDx elio tissue complete is expected to play a pivotal role in the development of new targeted cancer therapies. With the IVDR CE-mark in place, Labcorp is now preparing to offer the assay through its central laboratory in Geneva, Switzerland, for use in investigational clinical trials run by global pharmaceutical and biotechnology companies.
The ability to support large-scale clinical research programs across borders is a key differentiator for Labcorp, which has built a reputation for combining regulatory expertise with operational excellence. The Geneva facility will enable seamless deployment of the assay for biopharma partners conducting multi-year studies throughout Europe—especially those that need an IVDR-compliant solution to avoid disruptions during the ongoing regulatory transition.
By integrating PGDx elio tissue complete into clinical trials, sponsors can de-risk their development programs while ensuring they maintain consistent, high-quality genomic data collection across all trial sites. This is particularly crucial for oncology studies focused on biomarker-driven therapies, where accurate genomic characterization is central to patient selection, response monitoring, and regulatory submissions.
A Strategic Milestone in Labcorp’s Global Precision Medicine Strategy
The CE-marking of PGDx elio tissue complete under the IVDR is not an isolated achievement—it is part of Labcorp’s broader strategic commitment to expanding the global reach of precision medicine. With a strong presence in the United States, Europe, and beyond, Labcorp is positioned to support both commercial and investigational uses of its molecular diagnostic technologies across a wide range of clinical environments.
The company’s acquisition of Personal Genome Diagnostics (PGDx) in 2022 has played a key role in this effort, allowing Labcorp to integrate cutting-edge NGS assay development with its vast diagnostic infrastructure. PGDx’s proprietary technology, including the elio platform, was designed from the ground up to enable decentralized genomic testing, empowering labs to maintain control over sample processing and data interpretation while ensuring compliance with regulatory standards.
Now, with IVDR CE-marking secured, Labcorp’s assay portfolio is uniquely equipped to serve clinicians, patients, and drug developers alike, no matter where they are located in the cancer care continuum.
“This latest achievement is a testament to Labcorp’s mission of improving health and improving lives,” the company stated. “By bringing IVDR-certified, FDA-cleared diagnostic solutions to market, we are helping to accelerate the shift toward personalized, biomarker-guided treatment—offering hope to millions of patients across Europe and around the world.”
With the IVDR CE-marked PGDx elio tissue complete now available for implementation across Europe, the implications for healthcare systems, laboratories, and patients are profound. Not only does the test offer a validated, high-performance solution for genomic profiling, but it also represents a critical enabler of scalable, decentralized oncology diagnostics—a necessity as demand for precision medicine continues to rise.
As Labcorp moves forward with plans to support clinical trials and expand availability of the assay to more EU laboratories, the company is reinforcing its leadership in precision diagnostics while making a tangible impact on the future of cancer care.
