Analytical Validation of the Labcorp Plasma Complete Test, a Cell-Free DNA Comprehensive Genomic Profiling Tool for...

Area of Science:

• Oncology
• Genomics
• Molecular Diagnostics

Background:

• Tumor genomic profiling is crucial for precision oncology, guiding treatment and clinical trial matching.
• Liquid biopsy offers a less invasive alternative to tissue testing for detecting tumor DNA alterations.
• Labcorp Plasma Complete is a comprehensive genomic profiling test utilizing next-generation sequencing of cell-free DNA.

Purpose of the Study:

• To evaluate the analytical performance of Labcorp Plasma Complete for comprehensive genomic profiling.
• To establish the sensitivity, specificity, accuracy, and reproducibility of the test across various cancer types and variant types.

Main Methods:

• Analytical validation of Labcorp Plasma Complete using over 800 unique sequencing libraries across 27 cancer types.
• Assessment of sensitivity for single nucleotide variants (SNVs), insertions/deletions (indels), copy number amplifications (CNAs), translocations, and microsatellite instability-high (MSI-H).
• Evaluation of specificity, precision, reproducibility, repeatability (PRR), and accuracy using orthogonal assays.

Main Results:

• High sensitivity demonstrated for clinically actionable variants, with median VAFs of 1.25% for SNVs and 1.27% for indels.
• Exceptional specificity: 99.9999% for SNVs and 100% for other variant types.
• Excellent PRR (94.9% APA, 99.9% ANA for sequence mutations) and high accuracy (97.4% PPA, >99.99997% NPA) across all variant types.

Conclusions:

• Labcorp Plasma Complete exhibits high analytical sensitivity, specificity, accuracy, and robustness.
• The test is a reliable tool for comprehensive genomic profiling in advanced and metastatic solid cancers.
• The validated performance supports its use in guiding clinical decision-making for precision oncology.