PGDx elio® plasma focus™ Dx

The first and only FDA-authorized pan solid tumor liquid biopsy kitted solution

Contact Us
FDA-Authorized and Now Available for Ordering

Go live in as few as 6 weeks with our streamlined verification process.

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

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.

PGDx elio plasma focus Dx demonstrates high sensitivity across all variant types
Variant Category Reportable Range Analytical Sensitivity (LOD95*)
Actionable SNVs and Indels > 0.1% VAF ≥ 0.31% VAF
Nonactionable SNVs and Indels ≥ 0.5% VAF > 0.52% VAF
All Amplifications ≥ 1.2‑fold ≥ 1.3‑fold
All Translocations ≥ 3 fusion reads ≥ 0.41% FRF**

*LoD, limit of detection; **FRF, fusion read fraction

Why choose PGDx elio plasma focus Dx

Pgdx elio plasma focus dx kits
Eliminate the burden of full validation, enabling a go-live in as few as six weeks

• FDA-authorized assays eliminate the burden of full validation requiring only on-site verification steps

• Implementation support and dedicated project management accelerates path to go-live

Fast turnaround time

Experience rapid and scalable liquid biopsy genomic testing. Report actionable findings with confidence, all with 4 – 5 day turnaround time from isolated nucleic acid to variant report.

Sample and data ownership open avenues for both research and clinical studies

• Ensure sample chain of custody for accurate reporting

• Retain access to archival samples and data to drive novel insights

Workflow efficiency

Lower DNA inputs and robust workflows reduce sample drop out, and automated bioinformatics reduces the burden of manual variant curation.

Gene Panel

PGDx elio plasma focus Dx (33 Genes)
AKT1
BRCA1
CSF1R
HRAS
NTRK1
RET
ALK
BRCA2
EGFR
KIT
PDGFRA
ROS1
APC
BRIP1
ERBB2
KRAS
PIK3CA
TP53
ARID1A
CCND1
EZH2
MET
POLD1
ATM
CD274
FGFR1
MYC
POLE
BRAF
CDH1
FGFR2
NRAS
RAF1
Amplifications (5 Genes)
CCND1
CD274
ERBB2
FGFR2
MET
Translocations (3 Genes)
ALK
NTRK1
RET
Intuitive, scalable sample-to-answer solutions in your lab
1012751 image 4
Product specifications
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

Enable Seamless Tissue-to-Liquid Reflex Testing

PGDx elio plasma focus Dx and PGDx elio tissue complete are both FDA-authorized and share the same validated chemistry, bioinformatics servers, and DNA sequencers — delivering an efficient, streamlined workflow for both liquid and tissue testing.

Resources

TECHNICAL INFORMATION
PGDx elio plasma focus Dx technical information
Product brochure
 Verification document
 FDA-Authorized Tissue and Liquid Flyer

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.

Contact Us