Labcorp, a global leader of innovative and comprehensive laboratory services, announced today the expansion of its precision oncology portfolio with two solutions: Labcorp Plasma Detect for clinical use to help assess the risk of disease recurrence in stage III colon cancer patients, and the availability of PGDx elio plasma focus Dx, the first and only kitted, pan-solid tumor liquid biopsy test authorized by the U.S. Food and Drug Administration (FDA) to identify patients who may benefit from targeted treatments.
“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, medical lead for oncology at Labcorp. “With the expansion of our portfolio to include Labcorp Plasma Detect for clinical use and the availability of PGDx elio plasma focus Dx to support patient treatment selection, we’re advancing care across the oncology spectrum, solidifying our commitment to transforming cancer diagnostics and improving patient outcomes.”
Labcorp Plasma Detect: Advanced Risk Assessment for Colon Cancer Patients
Stage III colon cancer has a nearly 30% recurrence rate within five years. Labcorp Plasma Detect is a blood-based test using whole-genome sequencing (WGS) to detect circulating tumor DNA (ctDNA), indicating the presence of molecular residual disease (MRD).i Patients who are MRD-positive after cancer treatment have a higher risk of recurrence and a poorer prognosis. Labcorp’s test detects cancer recurrence risk that conventional methods might miss, helping to identify patients who could benefit from additional treatment or therapy.
Key Features of Labcorp Plasma Detect:
- The test is Labcorp’s first tumor-informed MRD solution for clinical use to support recurrence risk stratification. Labcorp Plasma Detect launched in 2024 for biopharma use to support exploratory and investigational studies.
- The test combines a WGS approach, without the need for a bespoke panel, with proprietary bioinformatics to deliver ctDNA detection down to a limit of detection (LOD95) of 0.005%.
- Results are available approximately 14 days after Labcorp receives the initial sample, and seven days for subsequent monitoring time points for each patient.
- Labcorp Plasma Detect is currently being evaluated in more than 10 clinical studies in the U.S. and internationally to assess MRD across various cancer types.
Labcorp Plasma Detect will be offered initially through an Early Experience Program, with the intent to expand availability more broadly.
PGDx elio plasma focus Dx Now Available for Use to Aid in Treatment Selection
PGDx elio plasma focus Dx is the first and only kitted pan-solid tumor liquid biopsy test to receive De Novo authorization from the FDA. This assay provides oncologists with a validated tool to assess various solid tumors for targeted treatment selection – all from a simple blood draw.
