Labcorp Announces Clinical Availability of Liquid Biopsy Test to Guide Personalized Treatment Plans for Patients with Advanced Solid Tumors

Rhea-AI Summary

Labcorp (NYSE: LH) has announced the clinical availability of Labcorp® Plasma Complete™, a liquid biopsy test for comprehensive genomic profiling in patients with advanced solid tumors. The test analyzes circulating tumor DNA (ctDNA) from a simple blood draw, detecting genomic alterations across 521 genes, including various mutations, amplifications in 12 genes, and translocations associated with 12 genes.

The test features high sensitivity with variant detection as low as 0.1% and specificity exceeding 99.99%. It provides insights for FDA-approved therapies, guideline-driven treatments, and clinical trial eligibility. The solution has been validated in Labcorp's CAP-accredited and CLIA-certified laboratory, with validation studies published in the Journal of Molecular Diagnostics confirming its clinical accuracy.

Positive

• Launch of innovative liquid biopsy test expanding diagnostic portfolio
• High test accuracy with >99.99% specificity and 0.1% detection sensitivity
• Comprehensive coverage of 521 genes for targeted treatment decisions
• Test validated and published in peer-reviewed journal

Negative

• None.

Labcorp® Plasma Complete^TM offers oncologists a highly sensitive and specific genomic profiling solution from a simple blood draw

BURLINGTON, N.C., Feb. 24, 2025 /PRNewswire/ -- Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, announced today the clinical availability of Labcorp® Plasma Complete^TM, 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," said Shakti Ramkissoon, M.D., Ph.D., 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."

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.

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.

For more information about Labcorp Plasma Complete, visit https://oncology.labcorp.com/plasma-complete

About Labcorp
Labcorp (NYSE: LH) is a global leader of innovative and comprehensive laboratory services that helps doctors, hospitals, pharmaceutical companies, researchers and patients make clear and confident decisions. We provide insights and advance science to improve health and improve lives through our unparalleled diagnostics and drug development laboratory capabilities. The company's nearly 70,000 employees serve clients in approximately 100 countries, provided support for more than 75% of the new drugs and therapeutic products approved in 2024 by the FDA, and perform more than 700 million tests annually for patients around the world. Learn more about us at www.labcorp.com. 

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.

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SOURCE Labcorp

FAQ

What is Labcorp's new Plasma Complete test and how does it work?

Labcorp Plasma Complete is a liquid biopsy test that analyzes circulating tumor DNA from blood samples to detect genomic alterations across 521 genes in patients with advanced solid tumors, helping guide personalized treatment decisions.

What is the accuracy rate of Labcorp's Plasma Complete (LH) test?

The test demonstrates high accuracy with a specificity greater than 99.99% and can detect variant allele frequencies as low as 0.1%, enabling precise detection of tumor-specific biomarkers.

How many genes can Labcorp's Plasma Complete test analyze?

Labcorp Plasma Complete analyzes 521 genes, including single nucleotide variants, insertions/deletions, amplifications in 12 genes, and translocations associated with 12 genes.

What certifications and validations does Labcorp's Plasma Complete test have?

The test is validated in Labcorp's CAP-accredited and CLIA-certified laboratory, with validation studies published in the Journal of Molecular Diagnostics confirming its clinical accuracy and reliability.