What were the major factors that made you adopt our solution in your daily routine? What do you value the most in our product?
As we are the first Department of Pathology in Germany and the first member within the German Network for Personalized Medicine (DNPM) to implement OncoDNA’s OncoDEEP®
Kit solution in our routine pan cancer genomic/molecular Dx NGS workflow for in-house comprehensive genomic profiling – our main priorities and added benefits are:
- most comprehensive pan-cancer genomic profiling test currently available on the market that uses a single NGS approach to simultaneously assess 638 DNA genes, 20 RNA genes, CNVs, and relevant cancer biomarkers as established in clinical guidelines and trials for therapy guidance such as homologous recombination deficiency (HRD), microsatellite instability (MSI), and tumor mutational burden (TMB) (in total 1.8 Mb).
- compatible with nucleic acids extracted from challenging and low-input FFPE samples. Less likely to exhaust limited tumor tissue biopsy samples reducing the risk of repeat biopsies.
- rapid turn-around time from nucleic acids extraction & quality control check, NGS library preparation and sequencing to clinical interpretation and reporting in 1 week.
- integrated clinical decision support platform for secondary analysis, variant interpretation and the final intuitive report with clinical recommendations.
- CE-IVD clearance.
- compatibility with the flexible and scalable NextSeq systems based on Illumina’s NGS technology to maximize lab budgets.
- automation-friendly NGS library preparation based on Twist Bioscience’s NGS technology enabling increased routine testing volumes.
Could you briefly explain the OncoDEEP® Kit integration stage?
Extensive validation of OncoDNA’s OncoDEEP®
workflow was performed on >250 FFPE tissue specimens (neoplastic content down to 20%) comprising multiple tumor types in combination with commercially available reference materials with known genomic profiles (e.g. TMB, HRD, MSI status) to assess analytical accuracy, sensitivity, and precision. In 2023, we successfully completed the external proficiency testing of HRD (QuiP; Quality in Pathology QuIP GmbH).
What were the challenges you faced during this integration stage?
The merge and harmonization of OncoDNA’s integrated clinical decision support platforms OncoKDM®
and MercuryTM, with OncoDNA’s BioIT team at hand to assist and manage the process.
What do you value most in your relationship with OncoDNA?
Generally speaking, we mostly appreciate the partnership based on the customer- and result orientated focus of OncoDNA’s team in providing rapid assistance and efficient troubleshooting which is crucial for our routine pan-cancer Dx laboratory practice.