Sold by: Bitscopic
Deployed on AWS
PraediGene automates genomic variant analysis, interpretation, annotation and reporting for clinical labs needing consistent, audit-ready results at scale.
Overview
PraediGene: Clinical-Grade Dry Lab Tertiary Analysis Software Platform for Genomics Automation, Analysis, Annotation and Reporting
PraediGene turns raw sequencing data into clinician-friendly, EMR-ready results. Built for clinical labs and health systems that need consistent interpretation workflows, standardized reporting, and clear decision trails for review and audit.
Deployed in the largest integrated health system in the United States, PraediGene is built for high-throughput operations where turnaround time, consistency, and audit readiness matter.
The PraediGene Difference: Interpretation You Can Stand Behind
PraediGene makes interpretation transparent and reviewable by linking each call to the evidence, rules, and inputs behind it.
- Traceable: Each call is linked to supporting evidence, applied rules, and underlying inputs
- Reproducible: Versioned logic and configurations support consistency across time, teams, and sites
- Auditable: A complete decision trail supports validation documentation, reviews, and audits
- Guideline-informed: Grounded in ACMG/AMP guidance including AMP somatic tiering where applicable
Clinical Domains Supported
- Molecular Oncology (Somatic): Therapy-relevant reporting with consistent classification and longitudinal clarity
- Molecular Genetics (Germline): Hereditary and rare disease workflows with transparent evidence trails
- Molecular Infectious Disease: Actionable outputs for resistance markers and surveillance-ready reporting
- Pharmacogenomics (PGx): Program-ready reporting to support precision prescribing workflows
Core Capabilities
Variant Interpretation, Annotation and Decision Support
- Evidence-linked classification rationale and interpretation trail
- Lab-configurable rules, thresholds, and policies
- Review workflows that support human oversight and sign-out
- BIAS-2015 classification engine - a peer-reviewed, published algorithm for automated variant classification using the ACMG 2015 framework
- BOLD-2022 oncogenicity prediction engine - standards-based oncogenocity assessment with full justification visualization
Clinician-Ready Reporting
- Domain-specific report templates (somatic, germline, infectious disease, PGx)
- Clear summaries with clinical context
- Configurable formats to align with your program and downstream consumers
Governance and Change Control
- Version control for interpretation logic and reporting configuration
- Traceable updates with controlled rollout options
- Designed to support verification and validation documentation expectations
Security and Operational Readiness
- Role-based access controls and audit logging
- Secure data handling aligned to HIPAA and institutional policies
- Architecture designed for regulated lab environments
- Supports CLIA and CAP compliance workflows
What Teams Stop Doing After Adopting PraediGene
- Maintaining fragmented rule sets across multiple tools and teams
- Rebuilding report templates and integrations for every new domain
- Manually assembling evidence during review, inspection, or audit
- Struggling to reproduce results when logic or tools change
Proven Results
At the Orlando VA Medical Center, PraediGene enabled the lab to become a reference center for advanced genomic testing with 75% lower cost testing in-house vs. send-out, 67% faster turnaround time, 3 laboratory developed tests validated and launched, and zero transcription errors through fully automated reporting.
About Bitscopic
Bitscopic helps health systems turn complex data into clear, decision-ready insight. With a decade of experience in federal and commercial health, Bitscopic supports mission-critical programs where audit readiness and reliability matter.
Intended use: PraediGene is intended for use by qualified personnel in CAP-accredited and CLIA-certified clinical laboratories to support laboratory workflows for genomic analysis, interpretation, annotation and reporting. Laboratories are responsible for validation, quality systems, and clinical decision-making.
Highlights
- Inspection-Ready Variant Interpretation: Every variant call is linked to supporting evidence, applied rules, and underlying inputs, making interpretation transparent, reproducible, and auditable. Versioned logic and configurations support consistency across time, teams, and sites.
- Enterprise Governance and Compliance: Built for CLIA and CAP-certified environments with full audit trails, role-based access controls, version-controlled interpretation policies, and structured reporting workflows. Supports verification and validation documentation expectations, change control processes, and regulatory inspection readiness. Deployed in the largest integrated health system in the United States, where audit readiness and operational consistency are non-negotiable requirements.
- Multi-Domain Clinical Reporting at Scale: Standardizes interpretation and reporting across molecular oncology, germline genetics, infectious disease, and pharmacogenomics from a single platform. Integrates with existing LIS, EHR, and LIMS systems through HL7 or API-based interfaces. Accepts FASTQ, BAM and VCF, enabling labs to scale their genomic testing menu without multiplying tools, rule sets, or reporting formats.
Details
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Delivery method
Deployed on AWS
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Pricing
Pricing is based on the duration and terms of your contract with the vendor. This entitles you to a specified quantity of use for the contract duration. If you choose not to renew or replace your contract before it ends, access to these entitlements will expire.
Additional AWS infrastructure costs may apply. Use the AWS Pricing Calculator to estimate your infrastructure costs.
Dimension | Description | Cost/12 months |
|---|---|---|
NGS Samples with less than 75 genes | Samples for small panels containing less than 75 genes | $90.00 |
NGS Samples with 75 - 300 genes | Samples for medium panels containing 75 - 300 genes | $175.00 |
NGS Samples with more than 300 genes | Samples for large panels containing over 300 genes (CES, WES, TSO500) | $225.00 |
Annual Praedigene License | Contract for the Praedigene platform for one calendar year | $10,000.00 |
Dimensions summary
This contract pricing combines a platform license with per-sample charges. You pay an Annual Praedigene License that covers access to the platform for one calendar year. On top of that, you pay for each sequencing sample you process. The per-sample price scales with panel size, split into three tiers: panels with fewer than 75 genes, panels with 75 to 300 genes, and panels with more than 300 genes (including CES, WES, and TSO500). Larger panels fall into higher per-sample units. Your total depends on the annual license plus your sample volume across these panel categories.
Top-of-mind questions for buyers
One sample is one sequencing specimen you process through the platform. The platform accepts standard genomic inputs such as raw sequencing reads, aligned sequence files, and variant call files. Each specimen is billed under the panel tier that matches its gene count, not by the number of files you upload.
The gene count of each panel sets its tier. Samples under 75 genes bill at the small-panel rate. Samples with 75 to 300 genes bill at the medium rate. Samples over 300 genes, including CES, WES, and TSO500, bill at the large-panel rate. Each sample is counted only in its matching tier.
Both apply together on the same contract. The Annual Praedigene License is a fixed charge covering platform access for one calendar year. Per-sample charges add on top and grow with your testing volume. For high-volume labs, sample charges tend to drive most of the total; the license stays constant.
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All charges are non-refundable except as required by applicable law or as otherwise set forth in a written agreement between you and the seller. To request a refund or cancellation, please contact us at support@bitscopic.com . AWS Marketplace standard cancellation policies apply, including a full refund for subscriptions cancelled within 48 hours of a non-private offer purchase.
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Delivery details
Software as a Service (SaaS)
SaaS delivers cloud-based software applications directly to customers over the internet. You can access these applications through a subscription model. You will pay recurring monthly usage fees through your AWS bill, while AWS handles deployment and infrastructure management, ensuring scalability, reliability, and seamless integration with other AWS services.
Support
Vendor support
Bitscopic provides direct support for PraediGene customers. Our team works directly with your technical and clinical stakeholders to configure integrations, address workflow questions, and resolve issues. Submit requests directly within the application using our integrated support widget; no switching tabs, no lost momentum.
For support inquiries, including troubleshooting, configuration assistance, and general questions about using PraediGene, please contact the Bitscopic team at support@bitscopic.com . Support includes assistance with LIMS and EHR integration setup, report template configuration, and workflow optimization.
To schedule a role-based demo or discuss how PraediGene fits into your laboratory environment, visit the Bitscopic website or reach out to the team directly.
AWS infrastructure support
AWS Support is a one-on-one, fast-response support channel that is staffed 24x7x365 with experienced and technical support engineers. The service helps customers of all sizes and technical abilities to successfully utilize the products and features provided by Amazon Web Services.
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