PMA P250036
- Device
- PGDx elio tissue complete CDx
- Applicant
- Personal Genome Diagnostics, Inc.
- PMA number
- P250036
- Product code
- PQP
- Decision date
- 2026-07-30
- Classification
- Medical Genetics
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- 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.
Current openFDA PMA Record#
- Device
- PGDx elio tissue complete CDx
- Applicant
- Personal Genome Diagnostics, Inc.
- PMA number
- P250036
- Product code
- PQP
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Decision date
- 2026-07-30
- Decision code
- APPR
- Date received
- 2025-09-10
- 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.