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.
__________________________________
1 Circulating tumor DNA guided adjuvant chemotherapy in
stage II colon cancer (MEDOCC-CrEATE): study protocol for a trial
within a cohort study
View original content to download
multimedia:https://www.prnewswire.com/news-releases/labcorp-launches-labcorp-plasma-detect-extending-leadership-into-molecular-residual-disease-mrd-clinical-research-302109236.html
SOURCE Labcorp