Labcorp has received de novo marketing authorization from the U.S. Food and Drug Administration (FDA) for its PGDx Elio Plasma Focus Dx kitted assay, a pan-solid tumor liquid biopsy test that enables tumor mutation profiling.
In a statement, the Burlington, N.C.-based Labcorp described the PGDx Elio Plasma Focus Dx as a qualitative next-generation sequencing-based IVD device that uses targeted high-throughput hybridization-based capture technology to detect single nucleotide variants, insertions and deletions in 33 genes, copy number amplifications in five genes, and translocations in three genes.
Labcorp added that the assay targets recommended biomarkers and is coupled with automated bioinformatics to assist oncologists in making timely treatment decisions in conjunction with other laboratory and clinical findings.
"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," Dr. Shakti Ramkissoon, PhD, vice president and medical lead for oncology at Labcorp, said.
"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."
