A guide for genome-based therapy planning

Evidence-based options for cancer patients in minutes

Access insights from the world's biomedical knowledge

MH Guide is an analysis software that supports molecular pathologists and oncologists in the interpretation of large molecular datasets. Independent of the sequencing technology used, MH Guide makes complex datasets readable. It automatically identifies genetic variants relevant for the treatment of your cancer patients and leverages one of the world’s largest, expertly curated learning databases –Dataome – to translate that information into actionable clinical knowledge:

  • What targeted or immuno-oncological therapies are promising for this individual genetic tumor profile?
  • Which therapies pose a safety risk?
  •  Are there ongoing (international) clinical trials for which the patient is eligible?

Now available in version 5.3, MH Guide is an evidence-based decision aid for precision medicine that is approved in Europe as an IVD medical device, according to Regulation (EU) 2017/746 (IVDR). 

Treatment-relevant results at a glance

Molecular pathologists, laboratory diagnosticians, and oncologists use MH Guide to automatically analyze NGS data and provide treating physicians with evidence-based individualized findings for the treatment of their cancer patients.

The MH Guide Report offers:

Overview of clinically-relevant biomarkers as well as derived therapy options

Evidence-based overview of potentially effective treatment options, classified as:

  • potentially effective drugs
  • ineffective drugs
  • drugs with safety concerns

Information on relevant, recruiting clinical trials

All relevant information on detected biomarkers such as:

  • the variant name
  • the biomarker’s score according to Association for Molecular Pathology (AMP), American Society of Clinical Oncology (ASCO), and College of American Pathologists (CAP) level IA-IV guidelines and clinical validation

Customization

  • Possible integration of analytical results from non-NGS methods such as FISH, IHC, qPCR
  • Ideal usability for molecular tumor boards

Discover here: the future of automated variant annotation

Ease of use

“MH Guide Reports are much clearer than those of the competition.” 

Dr. Christian Regenbrecht,
Professor, Medical Center University of Göttingen, 
CEO of CELLphenomics and ASC Oncology

Prof. Michael Hummel,
Head of Molecular Pathology,
Institute of Pathology at Charité Berlin

How molecular pathologists benefit

“We have been using MH Guide in our lab for several years and are very satisfied with its flexible application for the wide variety of tumor entities we work on.” 

One of the first approved IVD medical devices in molecular diagnostics, MH Guide supports molecular pathologists in annotating gene variants based on NGS data for small and large panels, as well as whole-exome sequencing (WES), or data from other compatible analytical methods.

The software allows automated comparisons with data from one of the world’s largest knowledge platforms: Dataome, which continuously processes published biomedical knowledge, pharmaceutical information, and details on current clinical trials.

Molecular Health can also assist you in annotating gene variants from whole-genome sequencing (WGS) analyses.

A web-based application, MH Guide fits perfectly into the routines of molecular pathology and diagnostic laboratories. The software helps annotate gene variants and generate patient reports, saving you time. You can individually adjust evaluation parameters, maintain and edit your own data, and customize the patient report. In addition, MH Guide supports interdisciplinary collaboration on molecular tumor boards, enabling case discussions with specialist colleagues via intuitive role management.

For more information, please see our brochure for molecular pathologists.

How oncologists benefit

“Patients with advanced ovarian cancer need additional treatment options to continue living with the disease. Tools like MH Guide help us identify these options.” ” 

For more information, please see our brochure for attending physicians.

Prof. Jalid Sehouli,
Director of the Clinic for Gynaecology Charité Comprehensive Cancer Center (CCCC), Berlin

How patients benefit

This case shows how the software can help identify effective therapies based on an individual’s molecular tumor characteristics.

Play Video about Molecular-Health_Jutta_Vinzent_MH_Guide_hat_mein_Leben_veraendert_DE

"Diagnosed with ovarian cancer IIIC,
MH Guide has changed my life with cancer."

Jutta Vinzent

MH Guide analysis in seven steps

1. Indication
The oncologist establishes the indication for molecular pathology diagnostics.

2. Order molecular diagnostics
The oncologist sends sample material (tumor biopsy or tumor sample) with referral and physician’s letter to their local pathologist, ordering the detection of tumor-relevant mutations.

3. Perform NGS analysis
In addition to examining the tumor, the pathologist (a) performs the NGS analysis or (b) commissions a molecular pathology laboratory to do so.

4. Upload NGS data to MH Guide
The laboratory performing the NGS analysis uploads the data to the MH Order Portal.

5. Analyze NGS data
MH Guide analyzes the NGS data, compares it with information provided by the Dataome knowledge base, and makes it possible to generate a customized report.

6. Findings
The laboratory processes the MH Guide report, signs it, and sends it to the pathologist in charge. The pathologist creates the findings report with all pathological results and the MH Guide report.

7. Select therapy options
The oncologist receives the findings from the pathologist in charge, including individual therapy options and possible clinical trials.

Video: The MH Guide analysis process

Flexibility and data security in one

The web-based software application MH Guide can be easily integrated in the laboratory. MH Guide enables the annotation and interpretation of genetic variants from common NGS or other analysis platforms.

The application allows users to generate highly-automated individual patient reports, each of which can be expanded and refined, including results from non-NGS methods (FISH, IHC, (q)PCR). The software generates clear, customizable report templates in various formats (PDF, JSON, XML) and is compatible with VCF and FASTQ data formats.

MH Guide meets the highest standards of data privacy, data security, as well as risk and quality management.

Approved for clinical use

MH Guide is a software application approved in Europe as an IVD medical device (according to the EU regulation 2017/746 (IVDR)).

SaaS – individually scalable

MH Guide is offered as scalable SaaS (Software as a Service) to suit small and large institutions alike.

Customizable patient reports

The design, content, and format of analysis reports can be adapted to individual needs on request.

Custom Field Inputs can be filled in during the standard ordering process and can be displayed as well as modified in the MH Guide user interface. They will be displayed on the user interface in your report.

Flexible input and output formats

MH Guide can process the standard data formats VCF and FASTQ. Output formats are PDF, JSON, and XML.

Secure data transmission

MH Guide provides secure transmission of patient data through advanced encryption standards (SSL/TLS, AES-256) and storage of patient data with controlled access authorization.

Guaranteed security of patient data

MH Guide complies with GDPR in Europe, GenDG in Germany, and the Health Insurance Portability and Accountability Act (HIPAA) in the USA.

Efficient workflows in your laboratory

MH Guide lets you optimize your everyday processes. The cloud-based software automates the interpretation of germline variants and delivers high-quality analyses.

MH VCF Adapter Suite

An intuitive and self-contained utility allows output data from different variant detection pipelines to be adapted to a format compatible with MH VCF. The MH VCF adapter suite includes adapters for Agena, Archer, AmoyDx, Illumina AmpliSeq, Illumina TSO500/TST170, Qiagen and Thermo Fisher Oncomine Comprehensive Assay pipelines and supports a wide range of NGS diagnostic workflows.

Optimized presentation of clinical trials

MH Guide identifies clinical trials that match the patient’s condition, treatment options and location. Through the search and filter function for e.g., biomarker criteria, study phase, recruitment status or other key parameters, the most suitable studies can be quickly identified. In addition, clinical trials from several countries can be displayed.

Intuitive reports in a few steps

MH Guide intuitively directs users from the uploading
of data until the final patient report.

1. Simple upload of the sequence data via
your browser in the MH Order Portal

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2. Automatic variant classification

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3. Creation of the report

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4. Export of the report

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Our solutions for hereditary cancers

For hereditary cancers​

Comprehensive applications for automated interpretation of NGS data from hereditary cancers
Our applications support you in identifying clinically-significant germline variants associated with hereditary breast and ovarian cancer syndrome (HBOC), or other hereditary cancers.
Find out more

"MH Guide is designed to support molecular pathologists, laboratory diagnosticians, and oncologists in their daily work. We will be happy to discuss how you can use MH Guide to achieve the best results for patients."

Dr. Matthias Kopf
VP, Head of Product Management & Customer Success

FAQs

In Germany, NGS-based tumor analysis and data evaluation with MH Guide are considered standard care for certain indications (billing via EBM by the pathologist). Insured patients can also request reimbursement from their health insurance company. In addition, analysis can be performed as a private service (for patients with private health insurance or those who pay the costs themselves). Please contact us with any questions: CustomerService@molecularhealth.com

MH Guide can process FASTQ and VCF data and offers pathologists highly-automated generation of individual patient reports, each of which can be expanded and refined, including results from non-NGS methods (FISH, IHC, (q)PCR). The software generates well-designed, adaptable report templates in various formats (PDF, JSON, XML).

MH Guide fulfills the highest standards in terms of data privacy and data protection, as well as risk and quality management. Data sovereignty always lies with the user. Confidential patient data is transmitted and stored using advanced encryption standards (SSL/TLS, AES-256).

This depends on your requirements. Prices are calculated based on the number of analyses and the size of the gene panels to be analyzed. We are happy to advise you personally.

You can use any commercially available or proprietary gene panels (small or large) and have the data analyzed in VCF format with MH Guide. Likewise, whole-exome sequencing (WES) data can be analyzed. In addition, MH Guide can analyze data from other sample assays if detected variant annotations are uploaded in VCF format. MH Guide can also process and analyze raw data (FASTQ) from many popular Illumina platforms. Molecular Health can assist with the annotation of gene variants from whole-genome sequencing (WGS) analyses upon request.

Yes, you can assign case-related accounts and rights, giving clinical colleagues access to the discussed case.

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