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# Labcorp Gets De Novo for Tumor Assay
- URL: https://www.fdaweb.com/labcorp-gets-de-novo-for-tumor-assay/
- Published: 2024-08-05T12:00:00.000Z
- Updated: 2026-09-14T14:37:22.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157500

FDA has granted Labcorp a de novo marketing authorization for its [PGDx elio plasma focus Dx](https://c212.net/c/link/?t=0&l=en&o=4225046-1&h=2984565428&u=https%3A%2F%2Fwww.personalgenome.com%2Fproducts%2Felio-plasma-focus-Dx&a=PGDx+elio%E2%84%A2%C2%A0plasma+focus+Dx&ref=fdaweb.com) kitted assay, a pan-solid tumor liquid biopsy test that enables tumor mutation profiling. PGDx elio is described as a qualitative next-generation sequencing-based in vitro diagnostic device that uses targeted high throughput hybridization-based capture technology for detecting single nucleotide variants, insertions and deletions in 33 genes, copy number amplifications 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,” the company says.