PGDx elio™ plasma focus Dx

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

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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.

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	> 0.76% 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

FDA-authorized assay

This solution, backed by the reliability and trust associated with FDA authorization, allows for seamless verification, eliminating the need for full validation. Go live in as few as 6 weeks.

Empowering your lab with our test

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.

Your samples, your data, your control

Retain complete control over valuable specimens and data.

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

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 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
Microsatellite Instability (MSI)	Yes
Variant Allele Frequency (VAF) to Report	0.1% (select actionable) 0.5% (all bases)
Sample Pass Rate	96%**

* Full workflow

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.

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