PGDx elio™ tissue complete supports clinical decision-making with an IVDR CE-marked solution compliant with the European Union’s (EU) In Vitro Diagnostic Regulation (IVDR 2017/746, Class C, NB 2797). This all-in-one sample-to-report kit, designed for in-house use by qualified professionals, features fully automated bioinformatics and expert implementation services for streamlined deployment.
PGDx elio™ tissue complete
The first and only IVDR CE-marked pan-solid tumor profiling kitted assay available in the European Union (EU)
For in-vitro diagnostic use in the EU only. For U.S. and non-EU visitors: please visit this page for information relevant to your region.
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Intended Purpose
PGDx elio™ tissue complete is a qualitative NGS-based in vitro diagnostic device that analyzes DNA from FFPE tumor tissue to detect clinically relevant tumor gene alterations across 505 genes for pan-solid tumors.
This assay is not conclusive or prescriptive for labelled use of any specific therapeutic product and has not been validated as a companion diagnostic (CDx) for any variants reported.
For patients previously diagnosed with solid malignant neoplasms.
PGDx elio TISSUE COMPLETE
Product overview
Benefits of the PGDx pan solid tumor CGP test
Equip your lab to deliver high quality insights
Reduced regulatory burden during IVDR transition timelines:
- IVDR certification ensures alignment with the highest safety and performance standards in the EU
- This designation provides a seamless clinical diagnostic assay experience throughout the IVDR transition.
- Custom implementation support and dedicated project management accelerates path to go-live
Provide robust, reliable and clinically comprehensive profiling that you can trust:
- Target guideline-driven biomarkers for pan-solid tumors:
505 clinically relevant genes, including key genomic signatures such as MSI and TMB - High clinical success rates: 93.2%
Open avenues for both research and clinical studies:
- Maintain sample chain of custody for accurate reporting and clinical compliance
- Retain access to archival samples to drive novel insights
500+ gene panel
IVDR-certified genomics insights on:
- Somatic mutations (SNVs, indels, amplifications, translocations)
- Microsatellite instability (MSI)
- Tumor mutation burden (TMB)
IVDR CE-marked
IVDR (EU) 2017/746 certified
Class C, Rule H
NB 2797
Turnaround time
5 days from isolated nucleic acid to variant report*
*Kitted workflow plus pipeline output. Not inclusive of DNA extraction and downstream processing. For professional use only.
CE-marked under IVDR 2017/746 (NB 2797). For professional use only by qualified healthcare professionals in certified laboratories. Consult the Instructions for Use (IFU) and Summary of Safety and Performance (SSP) for intended use, limitations, and performance data.
Resources
- Keefer LA, White JR, Wood DE, et al. Automated next-generation profiling of genomic alterations in human cancers. Nat Commun. 2022;13:2830. doi:10.1038/s41467-022 – 30380‑x. (https://pmc.ncbi.nlm.nih.gov/a…)
- Deak KL, Jackson JB, Valkenburg KC, et al. Next-Generation Sequencing Concordance Analysis of Comprehensive Solid Tumor Profiling between a Centralized Specialty Laboratory and the Decentralized Personal Genome Diagnostics elio Tissue Complete Kitted Solution. J Mol Diagn. 2021 Oct;23(10):1324 – 1333. doi: 10.1016/j.jmoldx.2021.07.004. (https://pmc.ncbi.nlm.nih.gov/a…)
Patent Disclaimer
For In Vitro Diagnostic Use.
Personal Genome Diagnostics Inc. (PGDx) is a subsidiary of Laboratory Corporation of America Holdings, using the brand Labcorp.
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