MH Guide 5.2 – Improved focus. Greater flexibility. Better usability.

MH Guide 5.2 – Improved focus. Greater flexibility. Better usability.

When it comes to targeted cancer treatments, new biomarkers are continually found, and additional treatment options are approved. Keeping pace with those changes with MH Guide 5.2.

Noteworthy updates include:

  • Regulatory agency information to focus on locally approved biomarkers
  • Multiple variants can be simultaneously managed with just a few clicks

Improved display of HRD and MSI scores

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MH Guide Webinar – 28.04.2022 5:00 pm CET

MH Guide Webinar – 28.04.2022 5:00 pm CET

You’re invited to Molecular Health’s MH Guide webinar, a free-to-attend virtual event showcasing how to automatically identify clinically actionable biomarkers in molecular tumor profiles of individual patients. It uses an expert-curated knowledge base that enables fast and standardized interpretation and reporting workflows for NGS labs of any size and any throughput demand.

Join our Live Webinar on on April 28th, 2022, at 5:00 pm CET to find out how to use MH Guide to scale and automate your workflows. Click here to register.

Molecular Health and collaborators prove new analytical approach that leverages real-world data to anticipate molecular causation of adverse drug reactions

Molecular Health and collaborators prove new analytical approach that leverages real-world data to anticipate molecular causation of adverse drug reactions

Heidelberg, 10 March 2022 – Molecular Health and collaborators at the University of Florida College of Pharmacy, Takeda Oncology, and thinkQ2 published a triad of articles that describe and prove the concept of a novel systems approach to elucidate molecular mechanisms of drug toxicities using real-world data (RWD).

We have established an approach that transforms real-world, in-human treatment outcomes and safety data into extensive datasets to better characterize desirable and undesirable interactions between molecular pathways and drugs,” explains Dr. David Jackson, Chief Innovation Officer at Molecular Health and co-author on all three articles. “The studies demonstrate a standardized strategy to extend mechanistic modeling and systems pharmacology into drug safety and mode of action assessments that has relevance for drug development and a variety of other contexts.”

In an article published in CPT: Pharmacometrics & Systems Pharmacology, the research groups at Molecular Health and University of Florida discuss the principles and future potential of applying a reverse translational strategy in drug development to investigate drug effects at the molecular level, understand causality, and anticipate prevalence of adverse effects. They then demonstrate the approach in two subsequent articles authored with collaborators at Takeda Oncology and thinkQ2. By mapping population-level adverse drug reaction data extracted from the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System back to molecular pathways and target profile data, the two proof-of-concept studies examined potential causes of cardiotoxicity and of colitis associated with well-known targeted cancer therapies. Using this analytical method, the authors developed hypotheses about different molecular mechanisms that accentuate or attenuate adverse effects depending on the nature of drug-drug combinations or on a drug’s target.

Dr. Mirjam Trame, Adjunct Professor at the University of Florida, principal investigator and corresponding author, Dr. Sarah Kim, Assistant Professor in the Department of Pharmaceutics, and Professor Emeritus Dr. Lawrence Lesko led the research collaboration. With nearly 20 years of experience directing Clinical Pharmacology at the U.S. FDA, Dr. Lesko is a renowned systems pharmacologist and Founding Director of the Center for Pharmacometrics and Systems Pharmacology at the University of Florida in Lake Nona. He emphasizes the importance of this work: “Registries of adverse events constitute a diverse, massive and valuable data source that has not been tapped into to generate and assess molecular hypotheses about causality. The expansion of adverse event information coupled with biological and chemical data, as demonstrated in these studies, is an improvement over traditional pharmacovigilance and can inform future clinical trial designs and personalized medicine.”

Merging molecular knowledge with post-marketing adverse event reports to assess drug safety

The first proof-of-concept study, published in Clinical and Translational Science (CTS), analyzed mechanistic hypotheses in light of cardiotoxicity reports from patients on trastuzumab (HerceptinR) combined with one of four other medications. A monoclonal antibody, trastuzumab targets HER2 and is used to treat breast cancer and advanced stomach cancer. Corroborated with experimental findings in the literature, the study suggested that trastuzumab-induced cardiotoxicity may be enhanced by doxorubicin via mitochondria dysfunction in cardiomyocytes, whereas the combination with tamoxifen, paroxetine, or lapatinib may diminish the undesirable effect by increasing antioxidant activities.

The second proof-of-concept study, published in CTS: Clinical and Translational Science, investigated autoimmunity associated with immunotherapies. The immune checkpoint inhibitors ipilimumab, nivolumab, and pembrolizumab are used for a broad range of cancers and treatment is often accompanied by severe colitis. Results of this study revealed that differences in mode of action – ipilimumab inhibits CTLA-4 whereas nivolumab and pembrolizumab target PD-1 – accounted for a three-fold higher reporting rate of colitis linked to ipilimumab. Mapping chemical and biological data to adverse events reports suggested that ipilimumab may unblock the immune response earlier, leading to heightened T-cell activation.

Press contact:
Thomas König
Molecular Health
Thomas.Koenig@molecularhealth.com
Phone: +49 (0)6221-43512280

About Molecular Health:

Molecular Health is an international biotech IT company based in Heidelberg, Germany, that has been developing innovative software in the areas of in silico and precision medicine since 2004. Molecular Health’s solutions leverage the transformation of large amounts of data into evidence-based, medically relevant decision support to benefit patients, healthcare providers, and drug developers. At Molecular Health, specialists in medicine, data science, biology, bioinformatics, and software development work to maintain and advance clinical decision support platforms that enable physicians to make better personalized treatment decisions. Exploiting its proprietary database Dataome with the power of AI analyses supervised by unbiased experts, Molecular Health enables innovative and value-adding decision making in the discovery and development of precision medicine. Molecular Health is a portfolio company of dievini Hopp Biotech holding GmbH & Co. KG.

Read more on www.molecularhealth.com

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GENOPATH GbR

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GENOPATH uses MH Guide for the comprehensive care of cancer patients

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With head offices in Bonn, Germany, GENOPATH GbR is an association of 16 pathology institutes. The group formed to supply all member laboratories with top-quality and cutting-edge molecular diagnostic services that complement existing histological and cytological methods, making the comprehensive care available to every cancer patient.

“GENOPATH wishes to offer all patients in our care the most modern and comprehensive methods in molecular pathology possible. With the MH Guide software, we now have automated interpretation of extensive tumor genetic data at our disposal. We look forward to working together with Molecular Health.”

Dr. Christoph Schmitt
Laboratory Director at GENOPATH

Challenge
The 16 laboratories of GENOPATH sought to harmonize the molecular pathology evaluations underpinning the care of cancer patients within their respective regions. A key issue was to ensure that the laboratories nevertheless had a broad menu of molecular tests to choose from.

Solution
The GENOPATH molecular laboratory performs a broad spectrum of tumor panels from different suppliers. Especially in the analysis of complex workups, as is often the case with multi-gene panels like the TSO500, output data are interpreted with MH Guide. Thus, the oncologist network supported by GENOPATH receives a standardized and comprehensive interpretation of molecular tumor data and information about therapy options.

Patient benefit
With up-to-date, comprehensive annotation of variants, each case evaluated by GENOPATH member laboratories results in an evidence-based decision about care for a patient. MH Guide enables harmonized data interpretation across laboratories and tests. Thus, the resulting reports are the basis for interactive discussions in the molecular tumor board to identify the best possible treatment, be it a targeted therapy or possibly participation in a clinical trial.

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GENOPATH GbR

With head offices in Bonn, Germany, GENOPATH GbR is an association of 16 pathology institutes. The group formed to supply all member laboratories with top-quality and cutting-edge molecular diagnostic services that complement existing histological and cytological methods, making the comprehensive care available to every cancer patient.

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OncoNet Rhein-Main e. V.

The OncoNet Rhein-Main is a network of clinics, molecular pathology laboratories, practices and medical centers that aims to provide effective and targeted care to all cancer patients in the Rhein-Main area. Working together, partners in the network support clinical studies to integrate innovative therapy approaches into daily clinical practice.

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Charité Institute of Pathology

The Institute of Pathology at the Charité Berlin is a key player in the care of cancer patients of the country’s capital and surrounding area. Their broad spectrum of analytical methods covers histological, cytological, and molecular diagnostics to deliver the reliable and timely identification of therapeutic options.

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