PGDx elio™ plasma focus Dx is the
industry's first and only kitted, pan-solid tumor liquid biopsy
test that enables tumor mutation profiling – all from a simple
blood draw
BURLINGTON, N.C., Aug. 2, 2024 /PRNewswire/ -- Labcorp (NYSE:
LH), a global leader of innovative and comprehensive laboratory
services, announced today it has received De Novo marketing
authorization from the U.S. Food and Drug Administration (FDA) for
PGDx elio™ plasma focus Dx – the industry's first
and only kitted, pan-solid tumor liquid biopsy test.
PGDx elio plasma focus Dx builds on the success of PGDx
elio™ tissue complete and enables laboratories to
perform genomic profiling when tissue is limited or
unavailable.
"The launch of PGDx elio plasma focus Dx represents a landmark
expansion of Labcorp's suite of precision oncology solutions," said
Shakti Ramkissoon, M.D., Ph.D., MBA, vice president, medical lead
for oncology at Labcorp. "This latest liquid biopsy test offers
laboratories and oncologists a convenient, cost-effective and
highly targeted tumor-profiling solution that spans a wide range of
solid-tumor types – particularly when tumor tissue is limited or
unavailable. When paired with PGDx elio tissue complete, Labcorp
now offers laboratories access to tissue and liquid
genomic-profiling assays that operate on the same instrument,
enabling seamless integration of these precision oncology products
into routine laboratory workflows. The ability to test tissue or
liquid will provide critical data and insights needed to inform
more personalized treatments and care plans for patients."
PGDx elio plasma focus Dx is a qualitative next-generation
sequencing-based in vitro diagnostic device that uses targeted high
throughput hybridization-based capture technology for the detection
of single nucleotide variants (SNVs), insertions and deletions
(indels) in 33 genes, copy number amplifications (CNAs) in five
genes, and translocations in three genes. The assay targets
guideline-recommended biomarkers to enable more accurate clinical
assessments and is coupled with automated bioinformatics to deliver
accelerated results. This solution enhances oncologists'
ability to make timely treatment decisions in conjunction with
other laboratory and clinical findings while also promoting sample
and data ownership.
PGDx elio plasma focus Dx is part of Labcorp's
comprehensive precision oncology portfolio of testing
solutions. For more information, visit
https://www.personalgenome.com
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 more than 67,000 employees serve clients in approximately
100 countries, provided support for 84% of the new drugs and
therapeutic products approved in 2023 by the FDA and performed more
than 600 million tests for patients around the world. Learn more
about us at www.labcorp.com.
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SOURCE Labcorp