Hedera Prime (CE-IVD certified under the IVDR) is an intuitive, cloud-based software solution developed in close collaboration with leading pathology laboratories to generate well-structured and customizable reports.

By automatically transforming raw NGS sequencing data into clinically relevant findings through advanced tertiary analysis, Hedera Prime enables efficient molecular diagnostics and helps laboratories to rapidly deliver the information essential for treatment decision-making.

Variant pathogenicity is assessed using multiple knowledge bases and databases, including ClinVar and OncoKB™. In addition, Hedera Prime incorporates a proprietary AI-assisted technology developed by Hedera Dx for the detection of gene fusions at the DNA level, enhancing the identification of complex variants in cfDNA samples.

Specialized algorithms for the detection of structural variants (SVs) complement the analysis of SNVs, InDels, and CNVs, enabling comprehensive molecular characterization. For impactful interpretation of liquid biopsy data, the software also determines the tumor fraction (TF) in cfDNA samples.

Within approximately 1,5 hours following FASTQ file upload, Hedera Prime delivers analysis results in a choice of formats, including PDF reports, JSON files, or VCF files, providing laboratories with rapid access to actionable molecular insights (the upload duration depends on the laboratory's network connection).

Hedera Prime strictly complies with the European General Data Protection Regulation (GDPR). Data processing takes place on European servers located in Frankfurt am Main, Germany. To ensure information security, Hedera Dx also maintains an ISO/IEC 27001-certified Information Security Management System. Through regular penetration testing and audits conducted by external IT security specialists, Hedera Prime is continuously verified to ensure compliance with the highest security standards in practice.