Hedera Profiling 2 ctDNA test panel
Compact ctDNA based liquid biopsy assay for profiling of most common solid tumors
Kits are commercialised together with the Hedera Prime software and cannot be purchased separately.
Fast sample-to-report workflow combining your existing instrument with Hedera Dx offering
Hands on time
From sample to report
Tertiary analysis & reporting
Hedera Profiling 2 ctDNA test panel:
a compendium of pure actionability
Compact but comprehensive
32 gene-panel for the detection of SNVs, Indels, CNVs, Fusions and MSI across > 6 most common tumor types in a single, DNA-only liquid biopsy assay
>80% of the ESCAT Level I genes are included in the panel
Fast and accurate
Swiftly integrates into your routine NGS workflow to get within 5 calendar days accurate results with 30 ng of cell-free DNA
Robust software analysis
Backed by Hedera Prime, a registered IVD Medical Device Software, save time on each report while ensuring accurate and reliable results
Validation support provided
Validation support is provided. Partner with us and let our IVDR expertise ensure a smooth integration of clinic-ready liquid biopsy in your lab
Tailored expert IVDR implementation program is provided, facilitating routine testing with in-house validation support meeting local compliance requirements
Hedera Profiling 2 ctDNA test panel: highly actionable for most common solid tumors
32-gene NGS panel optimized to run samples across > 6 solid tumor types and including the vast majority of ESCAT Level I biomarkers
>80% of all ESCAT Level I genes included in the panel.$
Most genes included in the panel are druggable.
Hedera Profiling 2 ctDNA test panel includes SNVs, Indels, CNVs, Fusions, and MSI
The panel detects a broad range of cfDNA variants as well as Microsatellite Instability (MSI).
Thoroughly verified and eases your local validation step
The panel offers highly sensitive and specific variant detection with 30 ng total cfDNA input, capable of identifying variants of high clinical interest, including those classified ESCAT Level I, at 0.5% VAF.
Results can be obtained within a swift 5 calendar days enabling labs to expedite testing timelines without compromising data accuracy, achieving an overall panel sensitivity > 97% and specificity > 99% at 0.5% VAF for key variants classified ESCAT Level I, across multiple cancer types.
Discover Hedera Comply, a tailored expert IVDR implementation program provided by Hedera Dx to help labs validate Hedera Profiling 2 ctDNA test panel and reach local compliance for routine testing with in-house validation and pre-filled IVDR documentation support.
- Panel size: 90 kb
- Instruments supported: Illumina NextSeq and NovaSeq Series
- Multiplexing: up to 6 samples on a NextSeq 500/550 instrument (MID Output flow cell)
- Sample size: min 5 mL plasma required (cfDNA BCT tubes by Streck recommended for blood collection)
- cfDNA input: min 10 ng cfDNA, 30 ng cfDNA recommended
- Library preparation method: hybrid-capture chemistry
- UMI/UDI technologies: allowing error correction and preventing index hopping for enhanced sensitivity and specificity
Hedera Dx A validation partner for the Lab
Comprehensive implementation program to facilitate the integration of compliant liquid biopsy in your lab.
The program provides onsite laboratory hands-on training, including a wet-lab instruction, a run assessment, a software training as well as a validation and technical support.
Supportive technical documentation is also supplied as pre-filled folder to facilitate your local compliance.
The Hedera Comply implementation program provides you with all that you need to run a local validation and develop a compliant in-house IVD liquid biopsy solution.
From onsite laboratory hands-on training to technical documentation supply and routine follow-up, Hedera Dx remains your local implementation and validation partner all the way through.
* Hedera Profiling 2 ctDNA test panel is labelled for Performance Studies Only. Not available in all countries including the United States. The clinical performance evaluation of Hedera Profiling 2 ctDNA test panel has not been established and users can run a local validation under CE-IVDR to ultimately use the assay as in-house IVD.
** Mechanism of resistance, non applicable for ESCAT (ESMO Scale of Clinical Actionability for molecular Targets).
$ NTRK 2/3 fusions and BRCA1/2 genes were not included in the panel to abate the overall panel size accommodating more sample multiplexing options with increased sensitivity. All other ESCAT Level I gene alterations are included.
1. Mosele, F et al. “Recommendations for the use of next-generation sequencing (NGS) for patients with metastatic cancers: a report from the ESMOPrecision Medicine Working Group.” Annals of oncology : official journal of the European Society for Medical Oncology vol. 31,11 (2020): 1491-1505.
2. Schmid, S et al. “How to read a next-generation sequencing report-what oncologists need to know.” ESMO open vol. 7,5 (2022):100570. doi:10.1016/j.esmoop.2022.100570