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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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DevicePGDx elio tissue complete CDx
Generic NameNext generation sequencing oncology panel, somatic or germline variant detection system
ApplicantPersonal Genome Diagnostics, Inc.
3600 Boston St.
Suite 10
Blatimore, MD 21224
PMA NumberP250036
Date Received09/10/2025
Decision Date07/30/2026
Product Code PQP 
Advisory Committee Molecular Genetics
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
PGDx elio tissue complete CDx is a qualitative next-generation sequencing-based in vitro diagnostic device that uses a high-throughput hybridization-based capture technology utilizing DNA isolated from formalin-fixed paraffin embedded tumor tissue. The PGDx elio tissue complete CDx targeted panel can detect single nucleotide variants, small insertions and deletions, copy number amplifications, and translocations. It is intended to be used as a companion diagnostic to identify melanoma patients who may benefit from treatment with the targeted therapies listed in Table 1.1 below in accordance with the approved therapeutic product labeling.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
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