PGDx Elio™ Tissue Complete
PGDx elio tissue complete profiles tumor DNA from formalin-fixed, paraffin-embedded tissue in patients with previously diagnosed solid cancers. The assay combines reagent kits with analysis…
PGDx elio tissue complete profiles tumor DNA from formalin-fixed, paraffin-embedded tissue in patients with previously diagnosed solid cancers. The assay combines reagent kits with analysis software and a server; the filed reagent kit is one part of that workflow.
The assay uses targeted next-generation sequencing across 505 genes. DNA is prepared as indexed libraries, enriched by hybrid capture and sequenced on a PGDx-qualified NextSeq 550Dx instrument. Software then identifies and reports genomic alterations.
Listed Item
PGDx elio™ tissue complete reagent kit
Capture and Reported Results
Biotinylated RNA probes bind targeted DNA regions, which are collected using streptavidin-coated magnetic beads. The assay reports single-nucleotide variants and small insertions/deletions, selected amplification and translocations, microsatellite instability and tumor mutation burden. Its report provides tumor-profiling information for qualified professionals and does not prescribe a specific therapy.
Who Else Makes It
Registered in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Geneseeq Medical Device AND Diagnostic Inc. | Nanjing | Jiangsu | Contract manufacturer | 1 |
Record
| Listed by | Personal Genome Diagnostics Inc., United States |
|---|---|
| FDA product code | PZM |
| Device type | Next Generation Sequencing Based Tumor Profiling Test |
| Device class | Class 2 |
| Regulation | 21 CFR 866.6080 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K192063 |
| Record published | 2020-05-11 |
| Record revised | 2024-08-07 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A0320100 | In distribution | |
| B01103200 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| PGDx elio™ server | Personal Genome Diagnostics Inc. | 4 |
| Geneseeqprime NGS Tumor Profiling Assay (Ffpe) | Geneseeq Technology Inc. | 1 |
| PGDx elio™ platform | Personal Genome Diagnostics Inc. | 1 |
| Geneseeqprime NGS Tumor Profiling Assay (Ffpe) Genesis by Geneseeq software | Geneseeq Technology Inc. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K192063 | 2020-04-24 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.