Labcorp Expands Precision Oncology Portfolio with Advanced Liquid Biopsy and MRD Testing Solutions
核心洞察
Labcorp has launched Plasma Detect, a blood-based test using whole-genome sequencing to assess recurrence risk in stage III colon cancer (搜索) patients by detecting circulating tumor DNA (搜索) with high sensitivity.
The company has made PGDx elio plasma focus Dx (搜索) commercially available, the first FDA-authorized kitted pan-solid tumor liquid biopsy test that enables hospitals to perform in-house genomic profiling with a 4-5 day turnaround time.
Labcorp Plasma Complete (搜索), a comprehensive 521-gene liquid biopsy test for advanced solid tumors (搜索), is now clinically available to guide personalized treatment decisions when tissue testing isn't feasible.
Labcorp, a global leader in laboratory services, has significantly expanded its precision oncology portfolio with the launch of multiple advanced liquid biopsy solutions designed to transform cancer diagnostics and treatment selection.
New Molecular Residual Disease Test for Colon Cancer Recurrence Risk
Labcorp has announced the clinical availability of Labcorp Plasma Detect (搜索), a blood-based test specifically designed to assess recurrence risk in stage III colon cancer (搜索) patients. The test utilizes whole-genome sequencing (WGS) to detect circulating tumor DNA (搜索) (ctDNA), which indicates the presence of molecular residual disease (搜索) (MRD).
With stage III colon cancer (搜索) carrying a nearly 30% recurrence rate within five years, this test addresses a critical clinical need. Patients who test positive for MRD after cancer treatment have been shown to have a higher risk of recurrence and poorer prognosis.
"Labcorp is dedicated to providing oncologists with a comprehensive portfolio of innovative solutions that enable precise, timely and personalized treatment decisions," said Shakti Ramkissoon, M.D., Ph.D., vice president and medical lead for oncology at Labcorp.
The Plasma Detect test combines WGS with proprietary bioinformatics to achieve a limit of detection (LOD95) of 0.005%, making it highly sensitive for detecting minimal amounts of ctDNA. Results are available approximately 14 days after initial sample receipt, with subsequent monitoring timepoints delivering results in just seven days.
Currently, Labcorp Plasma Detect (搜索) is being evaluated in more than 10 clinical studies across the U.S. and internationally to assess MRD in various cancer types. The test will initially be offered through an Early Experience Program before broader availability.
FDA-Authorized Liquid Biopsy Test for Treatment Selection
In addition to Plasma Detect, Labcorp has announced the availability of PGDx elio plasma focus Dx (搜索), the first and only kitted pan-solid tumor liquid biopsy test to receive De Novo authorization from the FDA. This test provides oncologists with a validated tool to assess various solid tumors (搜索) for targeted treatment selection from a simple blood draw.
The kitted model allows clinical laboratories and hospitals to maintain control over patient specimens and data while requiring only on-site verification rather than full validation, enabling faster implementation. Once implemented, the test provides actionable findings within a 4-to-5-day turnaround time.
As part of the PGDx elio platform, the test is compatible with FDA-cleared PGDx elio tissue complete, enabling seamless tissue-to-liquid reflexing and efficient comprehensive genomic profiling workflows.
Comprehensive Genomic Profiling for Advanced Solid Tumors
Labcorp has also announced the clinical availability of Labcorp Plasma Complete (搜索), a ctDNA-based comprehensive genomic profiling solution for patients with advanced solid tumors (搜索). This liquid biopsy test enables oncologists to perform comprehensive genomic profiling to inform personalized treatment decisions when tissue-based testing is not feasible.
"Labcorp Plasma Complete (搜索) delivers powerful and comprehensive genomic insights and helps guide targeted treatment decisions even when tissue-based testing is not feasible," explained Dr. Ramkissoon.
The test detects genomic alterations across 521 genes, including single nucleotide variants, insertions/deletions, amplifications in 12 genes, translocations associated with 12 genes, and microsatellite instability (搜索) high status. It covers established and emerging biomarkers associated with FDA-approved therapies, guideline-driven treatments, and clinical trial eligibility.
Rigorous validation studies published in the Journal of Molecular Diagnostics confirmed the test's clinical accuracy and reliability. Plasma Complete offers a reportable range with a variant allele frequency as low as 0.1% and a specificity greater than 99.99%, enabling precise detection of tumor-specific biomarkers associated with disease progression and therapy resistance.
Advancing Precision Oncology Through Liquid Biopsy
These new offerings represent a significant advancement in Labcorp's precision oncology capabilities, providing oncologists with multiple options for non-invasive testing that can guide treatment decisions across the cancer care continuum.
The expansion of Labcorp's liquid biopsy portfolio addresses several critical needs in oncology care: identifying patients at high risk of recurrence who might benefit from additional treatment, matching patients with targeted therapies based on their tumor's molecular profile, and monitoring treatment response over time.
"With the expansion of our portfolio to include Labcorp Plasma Detect (搜索) for clinical use and the availability of PGDx elio plasma focus Dx (搜索) to support patient treatment selection, we're advancing care across the oncology spectrum, solidifying our commitment to transforming cancer diagnostics and improving patient outcomes," said Dr. Ramkissoon.
Labcorp will present key studies on these technologies at the upcoming American Association for Cancer Research (AACR) 2025 Annual Meeting in Chicago, further demonstrating the clinical utility of these advanced diagnostic tools.