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.
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.
