Hedera Profiling 1 test panels
A high-performance and actionable assay for profiling of most common solid tumors on both FFPE and ctDNA samples
Kits are commercialised together with the Hedera Prime software and can 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 1 test panels:
Pure actionability
Compact but comprehensive
115 gene-panel for the detection of SNVs, Indels, CNVs, Fusions and MSI across all tumor types in a single, DNA-only assay
Highly actionable
covers all NCCN-guideline and ESCAT Level I genomic targets in solid tumors
Fast and accurate
Swiftly integrates into your routine NGS workflow to get accurate results with low input material within 5 calendar days.
Robust software analysis
Backed by Hedera Prime software, save time on each report while ensuring accurate and reliable results
Unique fusions detection method on DNA
Cutting-edge proprietary technology to detect fusions with unmatched precision, enhancing the accuracy of complex variants detection
Hedera Profiling 1 test panel: ESCAT table
Hedera Profiling 1 test panel includes SNVs, Indels, CNVs, Fusions, and MSI
Hedera Profiling 1 test panel - Specifications
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.
Hedera Dx An implementation 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.
* For Research Use Only. Not for use in diagnostic procedures. This product is intended for laboratory research purposes only and is not intended for use in the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This product has not been cleared or approved by any regulatory authority for clinical or diagnostic use.
