Labcorp Receives FDA De Novo Marketing Authorization for PGDx elio(TM) plasma focus Dx.

Labcorp has received De Novo marketing authorization from the U.S. Food and Drug Administration (FDA) for PGDx elio plasma focus Dx, which is the industry's first and only kitted, pan-solid tumor liquid biopsy test. This test allows laboratories to perform genomic profiling when tissue is limited or unavailable. It uses next-generation sequencing-based technology to detect genetic variants and biomarkers, providing oncologists with critical data to inform personalized treatments and care plans for patients. Labcorp's precision oncology portfolio now includes both tissue and liquid genomic-profiling assays, allowing for seamless integration into routine laboratory workflows. [Extracted from the article]