115 genes
The panel covers the genes that drive treatment decisions in the most common solid tumours.
DNA tumour profiling · Tissue and plasma
HP1 — a 115-gene panel from tissue and blood
Hedera Profiling 1 is an NGS panel for the most common solid tumours. It is a DNA panel that handles two sample types: tumour tissue from an FFPE block and ctDNA from plasma. The workflow is the same in both cases. The panel covers 100% of ESCAT Level I targets and all genes recommended in the NCCN guidelines.
- 115 Genes in the panel
- 2 Sample types: tissue and plasma
- 5 days From sample to clinical report
- 0.5% Limit of detection
About the test
One panel for tissue and blood
HP1 is designed so that the same workflow works on FFPE tissue and on circulating tumour DNA (ctDNA). The laboratory does not need to maintain two separate protocols. Only the input material differs: library preparation, sequencing and reporting are identical.
In a single test, HP1 detects SNVs, indels, CNVs and fusions. Fusions are detected directly from DNA using a patented technology. MSI is also included in the panel.
Specifications
What the HP1 panel covers in one test
100% ESCAT Level I
The panel covers all ESCAT Level I targets and the genes recommended in the NCCN guidelines.
Tissue and plasma
The same workflow for tissue samples and for liquid biopsy.
Fusions directly from DNA
The panel can detect gene fusions at the DNA level.
Input from 10 ng of DNA (cfDNA)
The low input requirement handles plasma (from 10 ng) as well as small biopsies (from 30 ng). Works with standard extraction kits.
Hedera Prime software
Data analysis and reporting in one place, from secondary analysis to the clinical report. The final analysis takes less than five minutes.
Panel content
The complete list of genes in the panel
Based on the original Hedera Dx specification. Genes shown in dark type are covered across the full coding sequence (Full CDS). MSI status is determined from 119 markers.
Workflow
From sample to report in 5 days
The entire workflow takes place in your laboratory. Hedera Dx supplies the kit, the library preparation protocol, hybrid capture and the Hedera Prime software. The output is a clinical report for the oncologist or molecular pathologist.
- 1
DNA extraction
From FFPE tissue or plasma. Library preparation requires a minimum of 30 ng of DNA from FFPE and 10 ng of cfDNA.
- 2
Library preparation with UMI
Twist Bioscience technology. Uses UMI to increase the accuracy of low-frequency variant detection. Runs on standard laboratory equipment, with nothing extra to buy.
- 3
Hybrid capture
Hybrid capture of 115 genes, including fusion detection directly from DNA.
- 4
Sequencing
The panel runs on standard Illumina and Element Biosciences sequencers.
- 5
Report in Hedera Prime
Complete data analysis through to the clinical report. The final analysis takes less than five minutes.
Implementation support
Hedera Comply — a path to routine use under IVDR
With HP1 you can use the Hedera Comply programme. It guides your laboratory through local validation and the transition to operation under IVDR. It includes on-site training for your team, technical documentation and ongoing support from Hedera Dx application specialists.
You do not have to handle validation and documentation on your own: you get a ready-made procedure that you simply follow.
- Local validation in clear steps
- On-site training for the laboratory and data analysis teams
- Technical documentation for the IVDR dossier
- Ongoing support from application specialists
Let's get started
Want HP1 in your lab?
We will walk you through the technical requirements, the sample specifications and how to use the Hedera Prime software. We can offer you a trial kit on favourable terms.