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Labcorp Says FDA Granted De Novo Marketing Authorization for PGDx Elio Plasma Focus Dx
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Labcorp Says FDA Granted De Novo Marketing Authorization for PGDx Elio Plasma Focus Dx
Aug 2, 2024 8:35 AM

11:26 AM EDT, 08/02/2024 (MT Newswires) -- Labcorp ( LH ) said Friday that the US Food and Drug Administration has granted de novo marketing authorization for the company's PGDx elio plasma focus Dx, a kitted, pan-solid tumor liquid biopsy test.

PGDx elio plasma focus Dx, an advanced liquid biopsy, allows genomic profiling without tissue. It detects key genetic variants and uses fast, automated bioinformatics, helping oncologists make quicker treatment decisions, the company said.

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