For Biopharma Partners
Labcorp® Plasma Detect™:
A WGS-based ctDNA assay for tumor-informed detection of MRD
Accelerate oncology therapeutic development with fast, high-confidence MRD assessment for global clinical trials
An advanced approach integrating WGS and proprietary machine learning for standardized tumor-informed MRD assessment
Building on a comprehensive portfolio of tissue, liquid biopsy and immune profiling solutions for solid tumors, Labcorp Plasma Detect provides precision monitoring for accelerated clinical trial enrichment strategies and enhanced therapeutic response assessment.
Assess the effectiveness of treatment and identify disease recurrence with an innovative tumor-informed ctDNA molecular residual disease (MRD) assay. This advanced approach integrates whole genome sequencing (WGS) and a proprietary machine learning analysis to identify a high-confidence, patient-specific mutation signature and track it over time—without the need for bespoke panel development.
Robust performance for translational research and clinical trials
Gain more insights with an innovative, sample-sparing approach to tumor-informed MRD assessment
with high sensitivity and specificity.
Sensitive
0.005% ctDNA content
Specific
99.4% specificity
Precise
100.0% APA at 0.05% ctDNA level
8.52% CV in ctDNA levels reported
Sample-sparing
Low input requirement (10 ng cfDNA) facilitates higher sample acceptance rate
Labcorp Plasma Detect defines a tumor-informed MRD signature using WGS of tumor DNA, germline DNA from buffy coat and cell-free DNA collected at the landmark time point. These data are analyzed with a proprietary machine learning algorithm to identify thousands of high-confidence, patient-specific somatic tissue variants, creating a signature that can be tracked over time to determine the ctDNA status.
Accelerate time to results with tumor-informed MRD reporting in as few as 14 days
Expedite trial enrichment and evaluation of treatment efficacy with landmark time point results in as few as 14 days and
longitudinal time point results in as few as 7 days.
The standardized WGS and proprietary machine learning workflow eliminates the need for bespoke panel development and
manual data curation, expediting delivery of results.
A scalable ctDNA MRD platform to support global clinical development
-
Available for research or investigational use
-
Developed under ISO 13485 design control
-
Performed in a CLIA-certified laboratory
-
Supported by Labcorp’s global laboratory and service network
Labcorp Plasma Detect assay specifications
| Test format | Test service for Research Use Only (RUO) |
|---|---|
| Sequencing workflow | Whole genome sequencing (WGS) |
| Analysis | Cell-free DNA (cfDNA) obtained through non-invasive blood draws. The landmark time point undergoes normalization to peripheral bone marrow cells' (PBMCs) DNA and tumor tissue to eliminate germline and non-tumor-specific variants, respectively, from the identified data |
| Turnaround time (receipt of sample to report) | As few as 14 days landmark time point, As few as 7 days longitudinal time point |
| Specimen type | Tumor tissue, buffy coat (PBMCs), plasma |
| Sample input and collection tube | Tissue: FFPE block or slides (5-10), ≥20% tumor purity Plasma and buffy coat: 1 EA Streck OR EDTA (10 mL BCT) |
| DNA input | 200 ng (tissue), 50 ng (buffy coat), 10 ng (plasma) |
| Alterations evaluated | A median of 5000 high confidence single nucleotide variants (SNVs) are identified to create an MRD signature that is tracked longitudinally |
| Analytical sensitivity | 0.005% ctDNA content |
| Analytical specificity | 99.4% |
| Precision | 100.0% APA at 0.05% ctDNA level 8.52% CV in ctDNA levels reported |
Enrich patient populations, assess patient prognosis and therapeutic response, and monitor disease recurrence
Empower your clinical trial with a clinically validated MRD assay capable of ctDNA MRD detection months earlier than the current standard of care.
Gain more high-confidence insights
- Tumor-informed WGS workflow offers high sensitivity and specificity
- Low input requirements facilitate higher sample acceptance rates
Save time with a standardized workflow
- WGS eliminates bespoke panel development
- Automated machine learning analysis
Streamline your development process
- Developed under design control to expedite assay deployment for clinical trials
- Backed by Labcorp’s global laboratory network to provide tailored solutions and expertise every step of the way
Stay Connected