Labcorp Receives FDA De Novo Marketing Authorization for PGDx elio™ plasma focus Dx
Rhea-AI Summary
Labcorp (NYSE: LH) has received FDA De Novo marketing authorization for PGDx elio™ plasma focus Dx, the industry's first and only kitted, pan-solid tumor liquid biopsy test. This innovative test enables tumor mutation profiling from a simple blood draw, offering a convenient solution when tissue samples are or unavailable. The test uses next-generation sequencing to detect various genetic alterations in 33 genes, including single nucleotide variants, insertions, deletions, copy number amplifications, and translocations.
PGDx elio plasma focus Dx complements Labcorp's existing tissue-based test, allowing laboratories to perform both tissue and liquid genomic profiling on the same instrument. This integration streamlines workflows and provides critical data for personalized cancer treatments. The test targets guideline-recommended biomarkers and uses automated bioinformatics for faster results, enhancing oncologists' ability to make timely treatment decisions.
Positive
- First FDA-authorized kitted, pan-solid tumor liquid biopsy test
- Enables tumor profiling when tissue samples are or unavailable
- Complements existing tissue-based test, allowing for seamless integration into laboratory workflows
- Targets guideline-recommended biomarkers for accurate clinical assessments
- Uses automated bioinformatics for faster results
Negative
- None.
News Market Reaction
On the day this news was published, LH gained 1.12%, reflecting a mild positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
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
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
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SOURCE Labcorp
FAQ
What is the PGDx elio™ plasma focus Dx test approved by the FDA for Labcorp (LH)?
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