US FDA Grants De Novo Marketing Authorization To Labcorp’s PGDx eLio Plasma Focus Dx

US FDA Grants De Novo Marketing Authorization To Labcorp’s PGDx eLio Plasma Focus Dx

By, Admin 6 August 2024

Overview

Labcorp, a global leader of innovative and comprehensive laboratory services, has received De Novo marketing authorization from the US Food and Drug Administration (FDA) for PGDx elio plasma focus Dx – the industry's first and only kitted, pan-solid tumour 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.

From The Medical Lead For Oncology at Labcorp

  • 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 tumour-profiling solution that spans a wide range of solid-tumour types – particularly when tumour 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

  • 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.

About Labcorp

Labcorp is a global leader of innovative and comprehensive laboratory services that helps doctors, hospitals, pharmaceutical companies, researchers and patients make clear and confident decisions.

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