Summary:
Labcorp has launched Labcorp Plasma Complete, a ctDNA-based liquid biopsy test for advanced solid tumors, enabling oncologists to perform comprehensive genomic profiling from a simple blood draw to guide personalized treatment decisions.

Takeaways:

  1. Extensive Genomic Profiling – Detects alterations in 521 genes, including SNVs, InDels, amplifications, translocations, and MSI-high status.
  2. Enhanced Oncology Support – Provides clear clinical reports and integrates with Labcorp’s broad cancer diagnostic portfolio to simplify treatment decisions.
  3. Validated Precision – Demonstrates high accuracy with a variant allele frequency as low as 0.1% and specificity over 99.99%, aiding in targeted therapy selection.

Labcorp, a global provider of comprehensive laboratory services, announced the clinical availability of Labcorp Plasma Complete, a circulating tumor DNA (ctDNA)-based comprehensive genomic profiling solution for patients with advanced solid tumors. The liquid biopsy test enables oncologists to perform comprehensive genomic profiling to inform personalized treatment decisions – all from a simple blood draw.

“Labcorp Plasma Complete delivers powerful and comprehensive genomic insights and helps guide targeted treatment decisions even when tissue-based testing is not feasible,” says Shakti Ramkissoon, MD, PhD, MBA, vice president and medical lead for oncology at Labcorp. “Now available for clinical use, Labcorp’s solution further expands Labcorp’s extensive oncology portfolio and reflects our commitment to supporting oncologists in delivering more personalized patient care.”

Genomic Alterations Detected by Labcorp Plasma Complete

Labcorp Plasma Complete detects genomic alterations in ctDNA across 521 genes. This includes single nucleotide variants (SNVs) and insertions/deletions (InDels), amplifications in 12 genes, translocations associated with 12 genes, and microsatellite instability (MSI) high status. The assay covers established and emerging biomarkers associated with FDA-approved therapies, guideline-driven treatments and clinical trial eligibility, providing oncologists with key insights to support personalized patient care.

Labcorp Plasma Complete also provides clear and comprehensive clinical reports supported by robust bioinformatics, simplifying the interpretation of complex genomic data and reducing the burden on oncologists. Integrating these capabilities with Labcorp’s broad cancer diagnostic portfolio helps reduce complexity for providers and guides treatment decisions across all stages of cancer care.

Available for Genomic Research and Clinical Patient Care

Labcorp Plasma Complete continues to be available for use in biopharmaceutical research in addition to its new application for clinical patient care. Labcorp Plasma Complete is a laboratory-developed test (LDT) and was validated in Labcorp’s College of American Pathologists (CAP)-accredited and Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory.i

Rigorous validation studies published in the Journal of Molecular Diagnostics confirmed the test’s clinical accuracy and reliability. The test offers a reportable range with a variant allele frequency as low as 0.1% and a specificity greater than 99.99%, enabling the precise detection of tumor-specific biomarkers associated with disease progression and therapy resistance. This level of variant detection allows for the identification of actionable mutations at low levels, providing oncologists with confidence in their treatment decisions.

Featured Image; Evgeniya Leonova | Dreamstime.com

Reference

i This test was developed and its performance characteristics determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration.