NEW YORK – Laboratory Corporation of America said Friday that it has received US Food and Drug Administration de novo marketing authorization for its PGDx Elio plasma focus Dx.
The Burlington, North Carolina-based company's test is a next-generation sequencing-based assay that allows for mutation profiling of solid tumors from blood samples.
The test uses targeted high-throughput hybridization-based capture technology to detect single nucleotide variants and insertions and deletions in 33 genes, copy number amplifications in five genes, and translocations in three genes. The assay targets guideline-recommended biomarkers and is coupled with automated bioinformatics.
The test complements Labcorp's PGDx Elio tissue complete test, allowing labs to perform mutation profiling when tissue is limited or unavailable, the company said.
"The launch of PGDx Elio plasma focus Dx represents a landmark expansion of Labcorp's suite of precision oncology solutions," Shakti Ramkissoon, VP and medical lead for oncology at Labcorp, said in a statement. "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. 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."