Labcorp Launches Labcorp Plasma Detect Extending Leadership into Molecular Residual Disease Clinical Research

BURLINGTON - Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, announced today the launch of Labcorp Plasma Detect, the first clinically validated, tumor-informed, whole-genome sequencing circulating tumor DNA (ctDNA) molecular residual disease (MRD) solution in early stage colon cancer to identify patients at increased risk of recurrence after surgery or adjuvant chemotherapy.

This solution, which is designed for research use but also suitable for clinical applications, can be applied across solid tumors with a scalable and standardized approach to facilitate faster turnaround times while maintaining high analytical performance.

The launch of the Labcorp Plasma Detect MRD solution further enhances Labcorp's leadership in precision oncology across the solid tumor oncology care continuum. Labcorp Plasma Detect builds on the successful deployment of two existing liquid biopsy platforms - Labcorp Plasma Focus, a targeted approach, and Labcorp Plasma Complete, a comprehensive profiling solution, both with utility for clinical research and clinical applications. All three solutions were developed by Personal Genome Diagnostics, Inc. (PGDx), a Labcorp company, and are performed in the PGDx Baltimore CAP-accredited and CLIA-certified laboratory.

'Labcorp Plasma Detect is a significant achievement, enhancing Labcorp's liquid biopsy portfolio and strengthening our position at the forefront of driving better patient outcomes in oncology,' said Shakti Ramkissoon, M.D., Ph.D., vice president, medical lead for oncology at Labcorp. 'Labcorp Plasma Detect delivers a high-impact solution for clinical research and biopharmaceutical drug development to support retrospective and prospective clinical trials with the goal of improving patient outcomes in early stage disease.'

The Labcorp Plasma Detect integrated whole-genome sequencing sample-to-report workflow was developed under PGDx's quality management system and design control process, undergoing rigorous analytical and clinical validation to demonstrate high sensitivity and specificity for ctDNA detection. It is backed by Labcorp's global network and expertise and does not require the manufacturing of patient-specific, bespoke panels, making it feasible to implement for research programs and clinical trials globally. Labcorp Plasma Detect is currently clinically validated for early-stage colon cancer, with ongoing efforts to expand into other indications, including lung cancer and bladder cancer.

In collaboration with the Netherlands Cancer Institute (NKI), Labcorp Plasma Detect validation data will be presented during a podium presentation - Clinical validity of post-surgery circulating tumor DNA testing in stage III colon cancer patients treated with adjuvant chemotherapy: the PROVENC3 study - at the annual meeting of the American Association for Cancer Research (AACR). Labcorp Plasma Detect will also be used to support the MEDOCC-CrEATE trial, an interventional, randomized study that will provide insight into the willingness of stage II colon cancer patients to be treated with ACT and whether ACT can prevent recurrences in a high-risk population.1

'There is an unmet clinical need to better determine who benefits from adjuvant treatment after surgical resection. The tumor-informed whole genome sequencing-based approach of Labcorp Plasma Detect tracks thousands of tumor-specific mutations in cell-free DNA, thereby offering a highly sensitive and specific ctDNA MRD test,' said Remond Fijneman, associate group leader and principal investigator at NKI. 'Combined with the relatively short turnaround time, which meets the timelines for clinical decision-making, ctDNA-guided treatment de-escalation is now within reach.'

About Labcorp

Labcorp (NYSE: LH) is a global leader of innovative and comprehensive laboratory services that helps doctors, hospitals, pharmaceutical companies, researchers and patients make clear and confident decisions. We provide insights and advance science to improve health and improve lives through our unparalleled diagnostics and drug development laboratory capabilities. The company's more than 67,000 employees serve clients in approximately 100 countries, provided support for 84% of the new drugs and therapeutic products approved in 2023 by the FDA, and performed more than 600 million tests for patients around the world.

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Christin O'Donnell

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