Knowledgebase

The Velsera Knowledgebase is an IVD-grade variant interpretation knowledge base that powers the Clinical Genomics Workspace (CGW) decision support software. Designed for clinical diagnostic laboratories, NGS assay and equipment manufacturers, and biotech and pharma organisations, it combines advanced technology with human expertise to deliver accurate, actionable genomic interpretations that support optimum treatment decisions for patients.

As medical knowledge and new therapies continue to expand rapidly, clinical labs face an overwhelming volume of genetic data requiring fast yet accurate interpretation. The Velsera Clinical Genomics Knowledgebase addresses this challenge by enabling laboratories to engage in the practice of medicine and assemble tailored clinical content for each patient.

Breadth of Knowledge

• Contains over 400,000 logical rules covering 1,250 somatic cancer genes
• Supports all major genomic variant types, including SNVs, TMB, MSI, indels, CNVs, fusions, and large structural variants
• Ensures robust support for complex genomic testing scenarios across diverse assay types

Depth of Knowledge

• Draws from FDA and EMA drug labels
• Incorporates oncology practice guidelines from NCCN, ASCO, and ESMO
• Integrates clinical trials data from ClinicalTrials.gov and the European Clinical Trial Register
• Leverages real-world medical data through the Velsera Clinical Sharing Network
• Includes public data sources such as COSMIC, TCGA, and ClinVar
• All content is continuously curated by a team of PhD- and MS-level scientists, enabling confident interpretation of even the most complex genomic variants

Currency and Reliability

• Expert biocurators continuously review and update the knowledgebase to ensure access to the latest clinical insights
• Monthly updates are pushed out to all CGW users automatically
• Each update is rigorously verified following SOPs designed to meet ISO 13485 standards
• Every patient report is backed by trustworthy, up-to-date evidence

Actionability and Intelligence

• Goes beyond simple variant lookups by leveraging a flexible metadata model and rules engine for comprehensive content matching
• Applies logic based on gene-variant-disease patterns to generate meaningful interpretations, even for previously undescribed variants
• Future-proofs the platform for emerging biomarkers and evolving genomic technologies

Who the Knowledgebase Supports

• Clinical Diagnostic Laboratories: Helps labs rapidly establish and grow NGS revenue streams, with support for validation, revenue cycle management, and clinical decision-making via the CGW
• NGS Assay and Equipment Manufacturers: Enables partners to bring new tests and equipment to market through custom-developed NGS analysis pipelines, regulatory support, and optional tertiary CGW reporting
• Biotech and Pharma: Supports companion diagnostic (CDx) design and development, including pipeline creation, regulatory compliance, reimbursement enablement, and integrated secondary and tertiary analysis packages

Solutions Supported

• Clinical interpretation and reporting
• NGS assay development and expansion
• IVD compliance transition and FDA clearance navigation for new assays and existing Laboratory Developed Tests (LDTs)
• Companion diagnostic development and scaling

The Velsera Knowledgebase is a core component of the Clinical Genomics Workspace and is available across more than 20 LDT and IVD assay options. It is built to meet ISO 13485 quality standards, making it suitable for regulated clinical environments and supporting labs navigating evolving compliance requirements.