Labcorp's PGDx elio™ Tissue Complete Receives IVDR CE-Marking in the EU

Labcorp Achieves IVDR CE-Marking for PGDx elio™ Tissue Complete

Labcorp, a renowned provider of laboratory services, has recently attained the prestigious IVDR CE-marking for its PGDx elio™ tissue complete test within the European Union. This milestone is crucial as it positions the PGDx elio™ as the first and only test of its kind approved under the newly established In Vitro Diagnostic Regulation in Europe, thus paving the way for an enhanced approach to cancer diagnostics.

Significance of the CE-Marking

The CE-marking enables Labcorp to broaden access to personalized cancer treatment solutions for the estimated 2.7 million individuals diagnosed with cancer annually in the EU. This sophisticated in vitro diagnostic (IVD) assay, which has also gained clearance from the U.S. Food and Drug Administration (FDA), is designed to facilitate guideline-based care for patients with solid tumors. By analyzing multiple biomarkers simultaneously—even with limited tissue samples—the test offers valuable insights that can significantly influence patient management and treatment timelines.

For many patients, this means a more timely initiation of effective management strategies, which can contribute positively to their prognosis. With the newfound CE-marking, an increasing number of laboratories across the EU can provide this vital test, expanding access to tailored cancer care.

Commitment to Precision Medicine

Dr. Shakti Ramkissoon, Labcorp's Vice President and Medical Lead for Oncology, emphasized the company’s commitment to advancing precision medicine. He stated, "This accomplishment reflects Labcorp's ongoing dedication to enhancing patient care. With both FDA clearance and IVDR CE-mark, this test sets a new standard for quality and performance in cancer diagnostics."

The implications of this achievement extend beyond individual patient care; it also provides Labcorp's biopharmaceutical partners with a dependable, regulatory-compliant solution. This is particularly beneficial for managing extensive multiyear clinical trials, ensuring ongoing continuity in next-generation sequencing (NGS) testing, even as the regulatory landscape evolves.

Benefits for Laboratories and Patients

Labcorp's PGDx elio tissue complete is structured to simplify in-house testing processes for laboratories while effectively reducing costs and accelerating implementation. The quicker laboratories can get testing done, the faster patients can access potentially life-saving diagnostics and treatments.

As Labcorp gears up to offer the CE-marked assay to biopharmaceutical partners and for investigational use in global clinical trials from its central laboratory located in Geneva, Switzerland, the company remains centered on its intrinsic mission: to improve health and enhance lives.

This recent accomplishment signifies a step forward in democratizing access to advanced cancer care, ultimately benefiting patients across Europe and beyond. Interested individuals or organizations looking for more details about this groundbreaking test can find further information at Labcorp's official webpage.

About Labcorp

Labcorp, trading under the symbol (NYSE: LH), stands as a global leader in innovative laboratory services. It enables healthcare providers, hospitals, pharmaceutical firms, researchers, and patients to make informed decisions based on precise and reliable insights. With a workforce of nearly 70,000 employees serving clients in around 100 countries, Labcorp supports a significant portion of new drugs and therapeutic products approved by the FDA and carries out over 700 million tests each year. For additional insights into Labcorp’s extensive services, visit their website.