MH Guide

MH Guide is an IVDR-compliant tertiary analysis and clinical decision support platform developed by Molecular Health, designed for molecular pathologists, oncologists, and other healthcare professionals working in precision oncology. The platform enables users to interpret next-generation sequencing (NGS) data and genetic and molecular alteration data, streamline report generation, and translate complex genomic findings into actionable clinical knowledge for patients diagnosed with solid tumors, hematological malignancies, and hereditary cancers.

Delivered as a Software as a Service (SaaS) application accessible via web browser, MH Guide requires no server hardware or additional IT infrastructure. It is panel-agnostic and secondary analysis pipeline-agnostic, supporting rapid onboarding and integration into existing laboratory workflows. The platform is available in selected EU countries and EFTA states where IVDR applies, as well as in the United States as a Research Use Only (RUO) version called MH Guide CAS.

Workflow: From Molecular Data to Actionable Insights

1. Data Upload: Cases are submitted in Variant Call Format (VCF) from secondary analysis platforms, including IVD, in-house IVD, or laboratory-developed test (LDT) pipelines. Upload options include the MH Order Portal (GUI) for low case volumes, MH VCF Adapter Suite (GUI or command line) for medium volumes, and MH Connector (GUI, command line, and APIs) for medium-to-high volumes with full automation support.
2. Variant Annotation: Automated annotation is powered by Molecular Health's proprietary, expertly curated knowledge base, Dataome, and supplemented by established public and commercial databases including ClinVar, dbSNP, gnomAD, COSMIC, ToMMo, BRCA Exchange, cancerhotspots.org, UniProt, RefSeq, Ensembl, and many more. Computational prediction scores (e.g., REVEL, MetaLR, MaxEntScan) and phylogenetic conservation scores (GERP, PhastCons, PhyloP) are also incorporated.
3. Interpretation of Findings: MH Guide applies multiple internationally recognised classification and tiering frameworks, including ACMG/AMP pathogenicity classification, ClinGen/CGC/VICC oncogenicity classification, and four clinical actionability tiering systems: ESCAT, AMP/ASCO/CAP, German DKTK/NCT, and the proprietary MH CVI scoring system. Findings are presented as standardised Curated Variant Information (CVI) narratives that detail biomarker type (predictive, diagnostic, prognostic), source citations, approval status of associated treatments, and matched therapy associations.
4. Clinical Trial and Therapy Matching: MH Guide provides region-specific content matching based on patient location, including drug approvals according to FDA or EMA guidelines, and location-based clinical trial matching with distance calculations to minimise patient inconvenience.
5. Report Generation: An automated summary report is generated with an editable summary statement and customisable report sections. Reports are exported in PDF and JSON formats. Non-NGS results (e.g., FISH, IHC, qPCR) can also be incorporated into the final report.

Key Features and Capabilities

• IVDR-compliant tertiary analysis for clinical use in oncology settings
• Monthly updates to the MH knowledge base ensuring access to current evidence and guidelines
• Support for multi-modal biomarkers via MH Connector, including gene/protein expression, methylation, and gene wild-type status in a unified workflow
• Plug-and-play compatibility with major secondary analysis platforms including Archer Analysis, Illumina DRAGEN, and Thermo Fisher Ion Reporter
• Automated pre-classification of variant pathogenicity and oncogenicity according to current recommendations
• Customisable, well-designed report templates in PDF and JSON formats
• Coverage of solid tumors, hematological malignancies, and hereditary cancers

Data Security and Compliance

• Compliant with GDPR, HIPAA, and the German Genetic Diagnostics Act (GenDG)
• Supports full pseudonymisation of patient data
• Data transmitted using advanced encryption standards (SSL/TLS, AES-256)
• Hosted in region-specific, certified data centres: Heidelberg iT (Germany) and AWS Europe (Paris, France); HDS-certified hosting for France; ACN-qualified hosting for Italy; TX-RAMP certified AWS hosting for US customers
• Data centres certified to ISO 27001 and/or Trusted Site Infrastructure (TSI) standards
• Meets data residency, data sovereignty, and local privacy requirements

Molecular Health also offers professional services to support LIMS integration, workflow automation, and bioinformatics, drawing on over ten years of experience integrating MH Guide into diverse IT environments. Services include customised genomic data integration, automated workflow development and management, assay validation consulting, and in-depth support for IDT/Archer NGS assays and bioinformatics platforms.