PGDx elio™ plasma focus Dx
The first and only FDA-authorized pan solid tumor liquid biopsy kitted solution
PGDx elio™ plasma focus Dx
Our in vitro diagnostic device is specifically designed to enable your in-house liquid biopsy profiling, serving as a reliable alternative to tissue genomic profiling for advanced cancers. It delivers actionable insights with a clinical success rate of over 96%.
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.
| Variant Category | Reportable Range |
|---|---|
| Actionable SNVs and Indels | > 0.1% VAF |
| Nonactionable SNVs and Indels | ≥ 0.5% VAF |
| All Amplifications | ≥ 1.2‑fold |
| All Translocations | ≥ 3 fusion reads |
*LoD, limit of detection; **FRF, fusion read fraction
Why choose PGDx elio™ plasma focus Dx
Gene Panel
| Specification | PGDx elio™ plasma focus Dx |
|---|---|
| Intended Use | IVD |
| Genes Evaluated | 33 |
| Panel Size | 0.24 Mb |
| Sample Matrix and Collection Tube | Plasma; Streck cell-free BCT® tubes |
| Sample Type and Input Quantity | cfDNA, 25 ng |
| System Compatibility | Illumina NextSeq 550Dx |
| Case per Sequencing Run | 8 samples (7 cases + 1 external control) |
| Read Length | 2x150bp |
| Average Total/De-duplicated Error-corrected Coverage | 30,000x/2,600x |
| Assay Time to Results | 4 – 5 days* |
| Bioinformatics workflow | Single automated pipeline |
| SNVs. Indels, Rearrangements, Amplifications | Yes |
| Variant Allele Frequency (VAF) to Report | 0.1% (select actionable), 0.5% (all bases) |
| Sample Pass Rate | 96% |
* Full workflow
Resources
We want to hear how we can support your lab diagnostic needs.
For more information, please contact your local Labcorp sales representative or email pgdxinfo@labcorp.com.