Labcorp Receives FDA De Novo Approval for PGDx elio™ Plasma Focus Diagnostic Test
Saturday, August 03, 2024
Labcorp (NYSE: LH) has announced that it has obtained De Novo marketing authorization from the U.S. Food and Drug Administration (FDA) for its PGDx elio™ plasma focus Dx. This test is the first of its kind—a kitted, pan-solid tumor liquid biopsy test available on the market.
The PGDx elio plasma focus Dx builds upon the capabilities of the PGDx elio™ tissue complete by enabling genomic profiling when tissue samples are limited or unavailable.
Labcorp, stated, "The launch of PGDx elio plasma focus Dx represents a major step forward in Labcorp's precision oncology solutions. This new liquid biopsy test provides a convenient, cost-effective, and precise method for profiling tumors across a wide range of solid tumors, particularly in cases where tissue samples are insufficient. When used in conjunction with PGDx elio tissue complete, our suite now supports both tissue and liquid genomic profiling on the same instrument, allowing for easy integration into routine lab workflows and aiding in the development of personalized treatment plans."
The PGDx elio plasma focus Dx is a next-generation sequencing-based in vitro diagnostic device that employs advanced hybridization-based capture technology. It detects single nucleotide variants (SNVs), insertions and deletions (indels) across 33 genes, copy number amplifications (CNAs) in five genes, and translocations in three genes. The assay focuses on biomarkers recommended by clinical guidelines, facilitating accurate assessments and delivering results more quickly through automated bioinformatics. This advancement aims to support oncologists in making informed treatment decisions and ensures better management of samples and data.
Source: labcorp.com
