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PRAEDIGENE

The Future of Dry Lab Bioinformatics for Pharmacogenomics and Precision Oncology

Advanced Genomic Reporting and Analytics

PraediGene delivers powerful, streamlined genomic analytics and reporting to optimize lab efficiency and enhance patient care.

 

Trusted by leading institutions, including the Department of Veterans Affairs, PraediGene seamlessly handles complex genomic workflows, drastically reducing the turnaround time from sequencing to actionable clinical insights.

 

Designed for scalability and clarity, PraediGene supports dry-lab operations across PGx, oncology, and inherited risk with automated secondary and tertiary analysis, integrated interpretation, and templated reports tailored for clinical use.

From sample tracking to variant annotation to EHR-ready output, PraediGene fits into your existing ecosystem without disrupting it. Whether you’re supporting LDTs or scaling enterprise precision medicine programs, PraediGene brings consistency, speed, and transparency to every stage of the reporting pipeline.

Precision Oncology: Transforming Somatic Genetics Data Into Action

PraediGene’s precision oncology solutions facilitate precise treatment strategies through comprehensive genomic profiling and advanced analytical pipelines.

Key Oncology Capabilities:
  • Profiling and interpretation for common, large cancer panels – including Illumina’s TruSight Oncology 500 panel and Pillar’s 50+ gene oncoReveal Myeloid Panel
  • Support for smaller panels targeting key cancer-risk genes (e.g., BRCA1/2, JAK2, CALR, MPL, etc).
  • Robust, streamlined clinical reporting with intuitive visualization of oncology-related genetic data.

Core Benefits for Oncology:
  • Rapid identification of actionable genetic mutations to inform targeted therapy choices.
  • Clinical trial matching.
  • Integration with clinical decision support systems (CDSS) for informed, personalized oncology treatments.

Pharmacogenomics: Precision in Medication Management

PraediGene revolutionizes pharmacogenomics by precisely predicting medication responses based on individual genetic profiles, significantly reducing adverse drug reactions and enhancing therapeutic effectiveness.

Key Pharmacogenomic Capabilities:
  • Comprehensive pharmacogenomic pipeline utilizing advanced tools built on top of standard industry software and knowledge repositories.
  • Accurate identification and interpretation of genetic variants affecting drug metabolism and efficacy.
  • Holistic analysis incorporating full contextual genetic picture.
  • FHIR/HL7: Automated, actionable pharmacogenomic reports integrated directly into HER via standard interfaces.

Core Benefits for Pharmacogenomics:
  • Personalized medication recommendations to optimize patient safety and treatment outcomes.
  • Reduction in medication-related hospitalizations through precise drug efficacy predictions.
  • Enhanced clinical decision-making with clear, actionable insights.
  • Increased patient satisfaction and improved experience.

Comprehensive Genomics Knowledgebase

PraediGene features an integrated knowledge base that is continuously updated with clinical evidence, variant classifications, clinical trials and therapeutic recommendations. Our knowledge base enhances test accuracy and supports rapid clinical decision-making by providing actionable, evidence-based insights.

The knowledge base is continuously updated as results are interpreted, classified and reported helping minimize re-interpretation, decreasing costs and enabling increased testing volume.

Multi-tier Analysis Support

Bitscopic’s bioinformatics team is ready to assist with your genomic analysis needs. Whether your lab is developing custom pipelines or using off-the-shelf tools, our experienced team can support all aspects of primary, secondary, and tertiary analysis. We help you translate raw sequencing data into clinically actionable reports – delivered with speed, accuracy, and regulatory alignment.

  • Primary Analysis: PraediGene processes raw sequencing data directly from lab instrumentation. Whether integrating tools like bcl2fastq in your end-to-end pipeline or integrating another primary analysis package, PraediGene seamlessly connects into your end-to-end workflow. The result: clean, demultiplexed reads ready for downstream analysis.
  • Secondary Analysis: PraediGene automates quality control, read alignment, variant calling, and normalization using industry-standard workflows. Steps include adapter trimming, file structuring, and the generation of high-confidence variant data – delivered rapidly and at scale – positioning your lab for efficient tertiary interpretation.
  • Tertiary Analysis: PraediGene provides powerful variant interpretation and annotation, transforming complex genetic data into clinically actionable insights. Customizable rulesets allow you to prioritize variants by tier, align with institutional or national guidelines, and generate provider-ready reports featuring diagnostic context, therapeutic options, and optional literature references.

Frequently Asked Questions

PraediGene supports the full lifecycle of LDTs by streamlining the entire dry lab workflow, from raw data ingestion to final clinical reporting. Whether you’re developing targeted pharmacogenomics panels, cancer risk assays, or rare disease pipelines, PraediGene helps your lab move faster, stay compliant, and scale with confidence.

Key areas of support include:

  • Validation: Built-in tools for data processing, quality control, variant analysis, and structured reporting support. PraediGene helps ensure your test performs as intended and your results are reproducible and traceable.
  • Regulatory: PraediGene supports dry lab compliance with major regulatory frameworks including CLIA and institutional compliance frameworks. With built-in audit trails, role-based access controls, and structured data outputs, PraediGene aligns with best practices for LDT oversight and documentation.
  • Commercialization: Custom-branded reports, EHR/LIMS integration, and streamlined reporting workflows help labs monetize new tests quickly and efficiently
With flexible configuration options and proven deployment in both clinical and research settings, PraediGene helps labs bring LDTs online without the operational complexity.
PraediGene supports MRD testing by extending the clinical value of the Bio-Rad QXDx™ BCR-ABL %IS assay with a streamlined digital workflow that simplifies result tracking, enhances reporting, and improves lab efficiency.
MRD (Measurable or Minimal Residual Disease) testing detects trace levels of cancer cells that remain after treatment – even when a patient is in “clinical remission.” This level of sensitivity, especially using digital droplet PCR (ddPCR), enables earlier detection of disease recurrence in conditions like chronic myeloid leukemia (CML), where MRD monitoring guides therapy adjustments and supports treatment-free remission (TFR) planning.

PraediGene enables a complete MRD workflow with:

  • Longitudinal tracking of BCR-ABL1 test results for individual patients, supporting quarterly CML monitoring and treatment response assessment.
  • Standardized, provider-friendly clinical reports with optional interpretive comments for oncologists and hematologists.
  • Secure EMR integration, allowing test results to flow directly into clinical systems to support timely, informed decisions.
  • Full audit trails and compliance tools that align with CLIA and institutional regulatory frameworks.
Whether you’re scaling an MRD program or bringing it in-house for the first time, PraediGene helps labs deliver precise, compliant, and efficient MRD testing without reinventing your digital infrastructure.

PraediGene supports MRD testing for solid tumors by enabling labs to track and report circulating tumor DNA (ctDNA) results with the same clarity, consistency, and regulatory compliance used in hematologic workflows. As MRD becomes increasingly valuable alongside neoadjuvant therapies in cancers like breast, colorectal, and lung, PraediGene helps labs operationalize ctDNA analysis through digital integration and longitudinal reporting with clinical clarity and regulatory confidence.

Key capabilities for solid tumor MRD workflows include:

  • Support for digital droplet PCR (ddPCR) or Next-Generation Sequencing (NGS) results: PraediGene accommodates ctDNA-based MRD assays that rely on ddPCR or other high-sensitivity detection methods.
  • Longitudinal result tracking: Capture and display serial ctDNA results over time to visualize molecular response trends across pre-, peri-, and post-treatment intervals.
  • Customizable clinical reports: Generate provider-friendly MRD reports that include interpretive comments, trend graphs, and therapeutic context.
  • EMR and LIMS integration: Deliver results directly to clinicians and link back to molecular test data for lab traceability.
  • Audit-ready infrastructure: Role-based access controls, secure data handling, and structured outputs help maintain compliance with oncology research protocols and clinical regulations.

As MRD testing evolves beyond hematologic malignancies, PraediGene ensures your lab is ready to support precision oncology for both blood-based and tissue-based solid tumor workflows.

PraediGene is designed to integrate seamlessly with most modern Laboratory Information Management Systems (LIMS) and Electronic Health Record (EHR) platforms. Our team works directly with your technical and clinical stakeholders to configure secure, automated data flows that reduce manual entry, eliminate silos, and ensure timely result delivery.

Integration capabilities include:

  • Bidirectional LIMS connectivity for automated sample tracking, result posting, and audit traceability.
  • EHR result delivery through HL7 or API-based interfaces, supporting timely access to MRD, PGx, and other genomics reports.
  • Custom mappings for test codes, patient identifiers, and report fields to ensure alignment with your existing systems.
  • Support for multi-site implementations with configurable permissions and access controls.
PraediGene enhances lab efficiency by working within your existing digital ecosystem.
PraediGene accepts a wide range of industry-standard data formats used in genomic testing, allowing labs to upload, process, and report results without reformatting or workflow disruption.
Supported input formats include:
  • FASTQ – Raw sequencing reads directly from NGS instruments
  • BAM/CRAM – Aligned sequence files for downstream variant analysis
  • VCF – Variant Call Format files for annotated or unannotated genomic variants
  • FASTA – Consensus sequences for alignment-based workflows
  • JSON/HL7 – Structured data formats for system integration and report delivery
  • CSV/TSV – Delimited formats for metadata uploads, test manifests, or batch processing
PraediGene’s flexible architecture allows labs to start at any point in the analysis pipeline, whether you’re submitting raw reads or preprocessed variant calls, and integrates easily with upstream and downstream systems such as LIMS, EMRs, or commercial analysis tools.
PraediGene fully supports major regulatory body compliant workflows and is designed to align with the operational and documentation standards required for inspections and lab accreditation.

Compliance-supporting features include:

  • Full audit trails to track user activity, test processing, and report generation. Role-based access controls for secure and segmented system usage.
  • CLIA and CAP compliant: software version control, KB management, integrated release notes, etc.
  • Structured reporting workflows that support LDT validation and regulatory documentation.
  • Customizable SOP-aligned outputs to meet the needs of individual certified labs.
  • Secure data handling and transmission in accordance with HIPAA and institutional policies.
PraediGene is actively deployed in CLIA and CAP-certified environments and supports the compliance needs of both clinical testing and translational research labs. For labs pursuing additional certifications or accreditations, our team works closely to ensure alignment with lab-specific quality and regulatory frameworks.
PraediGene supports a wide range of genomic assays across clinical, translational, and research use cases. The platform is designed to flex with your lab’s needs – from high-volume clinical tests to investigational studies – while maintaining consistency in analysis, reporting, and integration.

Supported assay types include:

    Pharmacogenomics (PGx) – Multigene panels for drug-gene interactions, polypharmacy, and personalized medication guidance.
  • Oncology – Tumor profiling (e.g., somatic variant detection), hereditary cancer risk (e.g., BRCA1/2), fusion genes, and tumor mutational burden (TMB) analysis.
  • MRD (Measurable Residual Disease) – BCR-ABL1 tracking for CML, and ctDNA-based testing for solid tumors using ddPCR or NGS.
  • Rare and inherited disease panels – Including panels for neurodevelopmental, metabolic, immunologic, and cardiovascular disorders.
  • Infectious disease sequencing – SARS-CoV-2, bacterial resistance markers, and pathogen surveillance for public health.
  • Custom or research-use-only assays – Configurable pipelines to support investigational tests, translational research, and institutional studies.
PraediGene accommodates a variety of data formats (FASTQ, BAM, VCF, etc.) and supports both targeted panels and broad-based sequencing efforts. Whether you’re running validated clinical tests or exploring new diagnostic applications, PraediGene delivers the workflow control, reporting clarity, and integration support your lab needs.
PraediGene supports full white-labeling of clinical and research reports, allowing your lab to deliver professionally branded outputs to clients, referring physicians, or health systems.

White-labeling capabilities include:

  • Custom logos and color schemes to reflect your lab’s branding or that of your clients.
  • Editable headers, footers, and disclaimers for alignment with lab-specific SOPs, certifications, or regional compliance language.
  • Configurable report layouts that match your test types, clinical audiences, or institutional preferences.
  • Branded PDF and electronic output options for LIMS integration, patient portals, or provider-facing systems.
Whether you’re offering testing under your own brand or serving as a reference lab for others, PraediGene ensures your reports look polished, consistent, and aligned with your business model.

Proven Scalability and Effectiveness

PraediGene has been successfully deployed in large-scale projects within the VA National Reference Labs, including the VA “SeqForce” COVID genome sequencing initiative, which has handled over 280,000 samples with high precision and reliability.

Key Features and Benefits for Genomics Laboratories

Feature Benefits

Seamless EHR & LIS Integration
Automated data integration with systems like VistA, eliminating errors and streamlining workflows.

Comprehensive Variant Analysis
Accurate identification and interpretation of common and rare genetic variants, enabling precise clinical actions.

Automated Report Generation
Standardized, clinical-grade, user-friendly reports with detailed genetic analysis and actionable insights.

Regulatory Compliance & Data Security
Strict adherence to regulatory standards ensures the security of patient data and compliance.

Financial Management Tools
Automated invoicing, comprehensive financial analytics, and streamlined billing processes.

Dynamic Response Platform
Flexible platform capable of adapting to evolving healthcare demands without compromising analysis quality.

Empower Your Genomics Capabilities Today

Bitscopic’s multidisciplinary team of clinicians, genomic scientists, and technologists is committed to advancing your clinical genomics practice through precision medicine.
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