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PGDx elio plasma focus Dx is the first and only FDA-authorized pan solid tumor liquid biopsy kitted solution...PGDx elio plasma focus Dx is a qualitative next-generation sequencing-based in vitro diagnostic device that uses targeted high throughput hybridization-based capture technology for the detection of single nucleotide variants (SNVs), insertions and deletions (indels) in 33 genes, copy number amplifications (CNAs) in five genes, and translocations in three genes.
Cancer:
Solid Tumor
Gene:
APC (APC Regulator Of WNT Signaling Pathway), ATM (ATM serine/threonine kinase), KRAS (KRAS proto-oncogene GTPase), POLD1 (DNA Polymerase Delta 1)
Method:
Next Generation Sequencing
Approvals
Date
Cancer
Gene
Drug
By
04/25/25
FDA Authorized (EUA/De Novo)