Labcorp Launches Labcorp® Plasma Detect™ Extending Leadership into Molecular Residual Disease (MRD) Clinical Research

Rhea-AI Summary

Labcorp launches Labcorp Plasma Detect, the first clinically validated MRD solution for early-stage colon cancer. The solution aims to identify patients at risk of recurrence after surgery or chemotherapy, enhancing Labcorp's precision oncology offerings.

Oncology Doctor

The introduction of Labcorp Plasma Detect represents a noteworthy advancement in the field of precision oncology. By leveraging whole-genome sequencing to detect circulating tumor DNA, this solution offers a more nuanced approach to monitor molecular residual disease in early-stage colon cancer. This is particularly significant given that early detection of recurrence can dramatically influence patient prognosis. The ability to track thousands of tumor-specific mutations in cell-free DNA could lead to more personalized and timely interventions, potentially sparing patients from unnecessary treatments and their associated toxicities.

From a clinical perspective, the non-invasive nature of liquid biopsies presents a less burdensome alternative to tissue biopsies, which are more invasive and carry a greater risk of complications. Moreover, the standardized approach of Labcorp Plasma Detect could harmonize MRD testing procedures, providing consistent and reliable results that are critical for making informed treatment decisions in a timely manner. The scalability of this solution may also facilitate broader adoption in clinical trials, which could accelerate the development of new therapeutic strategies and enhance our understanding of cancer biology.

Medical Research Analyst

The release of Labcorp Plasma Detect is set to have a tangible impact on the biopharmaceutical industry, particularly in the realms of clinical research and drug development. As MRD testing becomes increasingly integral to the oncology research toolkit, the ability of Labcorp's solution to provide high sensitivity and specificity is of paramount importance. The rigor of the analytical and clinical validation process underpins the reliability of the test, which is a critical factor for its adoption in both existing and future clinical trials.

Furthermore, the fact that Labcorp Plasma Detect does not require patient-specific panels is a significant technical and logistical advantage. It simplifies the process of implementing MRD testing on a global scale, which is particularly beneficial for multinational clinical trials. The potential expansion into other cancer indications, such as lung and bladder cancer, suggests a strategic move to diversify and capture a larger share of the MRD testing market. This could have a positive effect on Labcorp's financial performance, as the demand for precise and personalized cancer monitoring tools continues to grow.

Healthcare Industry Analyst

The launch of Labcorp Plasma Detect could be seen as a strategic enhancement to Labcorp's existing portfolio of liquid biopsy solutions, aimed at consolidating its market position in precision oncology. This move aligns with the growing trend towards personalized medicine and may increase Labcorp's competitiveness in the oncology diagnostics market. By offering a clinically validated, tumor-informed solution for early-stage colon cancer, Labcorp is addressing a key market need for accurate MRD assessment, which is critical for guiding adjuvant therapy decisions.

The collaboration with the Netherlands Cancer Institute and the inclusion of Labcorp Plasma Detect in the PROVENC3 study and MEDOCC-CrEATE trial underscore the clinical relevance of the solution and may boost its credibility among oncologists and clinical researchers. The potential benefits for Labcorp include strengthening its brand reputation, enhancing customer loyalty and potentially increasing market share in the oncology diagnostics space. However, the long-term impact on Labcorp's financials will depend on the clinical adoption rate, expansion into other indications and the outcome of ongoing and future clinical trials.

Labcorp Plasma Detect is the first clinically validated, whole-genome sequencing MRD solution for early-stage colon cancer

BURLINGTON, N.C., April 5, 2024 /PRNewswire/ -- 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 (ACT). 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."

To learn about Labcorp Plasma Detect, visit https://oncology.labcorp.com/plasma-detect

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. Learn more about us at www.labcorp.com.

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¹ Circulating tumor DNA guided adjuvant chemotherapy in stage II colon cancer (MEDOCC-CrEATE): study protocol for a trial within a cohort study

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SOURCE Labcorp

What is the significance of Labcorp Plasma Detect?

Labcorp Plasma Detect is the first clinically validated, tumor-informed, whole-genome sequencing MRD solution for early-stage colon cancer, aiming to identify patients at increased risk of recurrence after surgery or adjuvant chemotherapy.

Who developed Labcorp Plasma Detect?

Labcorp Plasma Detect was developed by Personal Genome Diagnostics, Inc. (PGDx), a Labcorp company, and is performed in the PGDx Baltimore CAP-accredited and CLIA-certified laboratory.

What other liquid biopsy platforms has Labcorp launched?

Labcorp has also launched Labcorp Plasma Focus, a targeted approach, and Labcorp Plasma Complete, a comprehensive profiling solution, both developed by PGDx and suitable for clinical research and applications.

Which cancers is Labcorp Plasma Detect currently clinically validated for?

Labcorp Plasma Detect is currently clinically validated for early-stage colon cancer, with plans to expand into other indications such as lung cancer and bladder cancer.

What upcoming trials will utilize Labcorp Plasma Detect?

Labcorp Plasma Detect will be used in the MEDOCC-CrEATE trial to determine the willingness of stage II colon cancer patients to be treated with adjuvant chemotherapy and whether it can prevent recurrences in a high-risk population.