Labcorp Accelerates Molecular Residual Disease Research

BURLINGTON, NC — Labcorp recently announced 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 (ACT). This solution—designed for research use but also suitable for clinical applications—can be applied across solid tumors with a scalable and standardized approach to shorten turnaround times while maintaining high analytical performance.

“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,” said Shakti Ramkissoon, MD, PhD, vice president, medical lead for oncology at Labcorp. 

The Labcorp Plasma Detect™ integrated whole-genome sequencing sample-to-report workflow was developed under Personal Genome Diagnostics’ (PGDx’s) quality management system and design control process, undergoing rigorous analytical and clinical validation to demonstrate high sensitivity and specificity for ctDNA detection. Backed by Labcorp’s global network, it does not require the manufacturing of patient-specific, bespoke panels, simplifying implementation for research programs and clinical trials across the world. 

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. It will also be used to support the MEDOCC-CrEATE trial, an interventional, randomized study that will provide insight into the willingness of stage-2 colon cancer patients to be treated with ACT and whether ACT can prevent recurrences in a high-risk population.  

“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, PhD, associate group leader and principal investigator at the Netherlands Cancer Institute. “Combined with the relatively short turnaround time, which meets the timelines for clinical decision-making, ctDNA-guided treatment de-escalation is now within reach.”

- This press release is supported by Labcorp