Labcorp Celebrates IVDR CE-Marking for PGDx elio™ Tissue Complete
Labcorp, a renowned leader in laboratory services, has announced a significant achievement in expanding access to personalized cancer care. With the recent CE-marking of the PGDx elio™ tissue complete under the EU’s In Vitro Diagnostic Regulation (IVDR), this test becomes the first of its kind approved in the European Union.
This innovative diagnostic tool is set to revolutionize how we address solid tumors. By enabling comprehensive profiling, it is estimated to assist approximately 2.7 million individuals diagnosed with cancer annually in the EU. For patients, this breakthrough signifies earlier access to tailored treatment options, potentially improving their prognosis.
Understanding the PGDx elio™ Tissue Complete
The PGDx elio™ tissue complete is an in vitro diagnostic (IVD) assay previously cleared by the U.S. Food and Drug Administration (FDA). Its unique ability to analyze multiple biomarkers from limited tissue samples is a game-changer for physicians. Having this information at their disposal facilitates guiding clinical management to bolster patient care.
Shakti Ramkissoon, M.D., Ph.D., MBA, vice president and medical lead for oncology at Labcorp, remarked, "This accomplishment reflects Labcorp's commitment to advancing precision medicine and improving patient care." By achieving both FDA clearance and IVDR CE-mark, Labcorp has established a new standard for quality and performance that supports biopharmaceutical partners with regulatory-ready solutions.
Expanding Access to Personalized Cancer Care
As Labcorp prepares to roll out the CE-marked assay for biopharma collaborators and in investigational use in global clinical trials, it underscores the company’s dedication to enhancing health and improving lives. By making the test available to more laboratories across the EU, the hope is to facilitate quicker patient testing and streamline the diagnostic process.
Insurance of Quality and Performance
This achievement opens the door for more laboratories to embrace in-house testing, thereby reducing costs and accelerating implementation timelines. The PGDx elio™ tissue complete not only supports prompt patient evaluations but also ensures that quality is never compromised.
The Bigger Picture for Labcorp
Labcorp’s nearly 70,000 employees strive to deliver actionable insights, helping hospitals, doctors, and pharmaceutical companies make informed decisions. With over 700 million tests performed annually across approximately 100 countries, their influence on health care is profound. In 2024, they supported the approval of over 75% of new drugs and therapeutic products by the FDA, highlighting their essential role in advancing science and health outcomes.
As Labcorp continues to position itself as a pillar of innovation in laboratory services, the CE-marking of PGDx elio™ tissue complete is yet another testament to their commitment to improving patient outcomes and accessibility. This milestone is not just a victory for Labcorp but for the entire ecosystem of cancer care.
Frequently Asked Questions
What is the PGDx elio™ tissue complete?
The PGDx elio™ tissue complete is an innovative in vitro diagnostic assay that allows for comprehensive profiling of solid tumors, helping healthcare providers make informed decisions on patient care.
How does the CE-marking impact patient care?
The CE-marking of PGDx elio™ tissue complete enables more laboratories in the EU to offer this vital test, thus improving access to personalized cancer treatment and accelerating the diagnostic process.
What is Labcorp's commitment to cancer care?
Labcorp is dedicated to advancing precision medicine and enhancing patient care through innovative laboratory services, evidenced by its achievements, including the CE-mark for PGDx elio™ tissue complete.
How many tests does Labcorp perform annually?
Labcorp conducts over 700 million tests each year, serving clients in about 100 countries and supporting significant advancements in diagnostics and drug development.
What are the regulatory clearances for PGDx elio™ tissue complete?
The PGDx elio™ tissue complete has received both FDA clearance and IVDR CE-marking, showcasing its quality and performance in cancer diagnostics.
