Labcorp has received US FDA De Novo marketing approval for PGDx elio plasma focus Dx, which is claimed to be the first and only test kit in the industry for pan-solid tumor liquid biopsy. The pricing details were not disclosed.
PGDx elio plasma focus Dx uses next-generation sequencing to detect single nucleotide variants (SNVs), insertions, and deletions (indels) in 33 genes, copy number amplifications (CNAs) in five genes, and translocations in three genes. The test uses high-throughput hybridization-based capture technology and is complemented by automated bioinformatics for quick results.
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