Labcorp® Plasma CompleteTM
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
CompleteTM, 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
