PARIS and SAN DIEGO, Oct. 12, 2020 /PRNewswire/ -- WeHealth™ Digital Medicine, Servier Group's e-health business unit, and CureMatch®, a leader in digital health precision medicine today announced that they have received CE Mark approval for Bionov™, their professional-use clinical decision support software.
Bionov is a clinical decision support software platform that presents healthcare professionals with personalized single drug and combination drug treatment options based primarily on the molecular profile of their cancer patients. Bionov uses proprietary algorithms to analyze over 4.5 million combinations of commonly used and newly approved European Medicines Agency (EMA) and/or Food and Drug Administration (FDA) cancer treatments and scores and ranks the treatment regimen options that most comprehensively target the patient-specific molecular aberrations. The findings are presented in a simple report layout of ranked monotherapies to two and three drug combination therapies to potentially help oncologists identify personalized therapies for each patient. The Bionov report is designed to provide actionable knowledge and insights to help healthcare professionals make informed decisions about personalized drug treatments for each of their patients.
"Decision-support platforms like Bionov™ are innovative tools that help oncologists evaluate volumes of immensely complicated data in an effort to help make the best treatment decisions for the patients they serve," said Razelle Kurzrock, M.D., Director of the Center for Personalized Cancer Therapy at Moores Cancer Center at UC San Diego Health and Chief Medical Advisor for CureMatch. "In my experience the Bionov ranking and scoring system provides oncologists with context and perspective on regimens that best match the unique aspects of a patient's molecular profile."
Bionov has been available in the U.S. as professional-use clinical decision support software since 2018 and is currently used in academic hospitals, regional cancer care centers, clinics and by diagnostic labs. CE certification indicates that CureMatch confirms that Bionov meets European Union quality standards for design, manufacture, and final inspection as required under the Council Directive 93/42/EEC.
"The vision of WeHealth™ is to offer a precision medicine approach where the patient is at the center of an individualized diagnosis and treatment," said David Guez, M.D., Executive Director Innovation & Scouting at Servier's WeHealth Digital Medicine. "Our collaboration with CureMatch delivers an innovative tool for oncologists that may provide a large spectrum of potential benefits for the patient including better disease management."
Oncology often relies on treating patients with a single, molecularly matched therapy that targets one mutation in their tumor. However, as patients' tumors are frequently characterized by several actionable alterations, it becomes challenging to identify possible combinations of drugs needed to co-target all affected pathways1. According to one publication treating patients with individualized matched combination therapies targeting most of their tumors' alterations were associated with improved outcomes. Specifically, the I-PREDICT study2 showed that higher matching score was an independent predictor of prolonged progression-free and overall survival rates, suggesting validity of the customized targeted combination therapy approach in cancer treatment.
Bionov is a rule-based platform that utilizes scientific knowledge and mathematical modeling to rank regimens using a predictive 'Bionov score' that reflects the degree to which a given regimen matches the patient's molecular profile. The scientific principles of Bionov were recently discussed in an article2 published in January 2020: this retrospective meta-analysis of 70 exceptional responders for whom molecular profiling data was available, the computational platform (PreciGene® newly named Bionov) correctly ranked the response to all treatment regimens (including failed regimens) with 84% sensitivity and 77% specificity. These data demonstrate the algorithm's ability to discriminate, solely on the basis of the molecular fingerprints of a patient's cancer, treatment regimens that favor a positive outcome from those that are more likely to be associated with an unsuccessful response.
United States: Bionov is a clinical decision support software and is not considered to be a medical device as defined under the Federal Food, Drug and Cosmetic Act section 520(o) as amended by the 21st Century Cures Act."
European Union: CureMatch, Inc. declares Bionov complies with the Medical Devices Directive (MDD) 93/42/EEC through application of the CE-mark to the Bionov product. Bionov is considered a class I self-certified medical device under rules 1 and 12 of MDD Annex IX.
CureMatch is a leader in precision medicine digital solutions. Created on the belief that oncologists everywhere should benefit from world-class research, the CureMatch Decision Support System guides oncologists in the selection of cancer drugs that are customized for individual patients based on the molecular profile of their tumor, allowing each oncologist to become an expert in personalized medicine for better patient outcomes.
Servier is an international pharmaceutical company governed by a non-profit foundation, with its headquarters in France (Suresnes). With a strong international presence in 150 countries and a total revenue of 4.6 billion euros in 2019, Servier employs 22,000 people worldwide. Entirely independent, the Group invests on average 25% of its total revenue (excluding generics) every year in research and development and uses all its profits for its development. Corporate growth is driven by Servier's constant commitment in five areas of excellence: cardiovascular, immune-inflammatory, and neurodegenerative diseases, cancer and diabetes, as well as by its activities in high-quality generic drugs. Servier also offers eHealth solutions beyond drug development. More information: www.servier.com.
About WeHealth™ Digital Medicine
WeHealth Digital Medicine, aims to improve the daily life of patients and health professionals' alike using digital, is the e-Health business unit of the Servier Group.
WeHealth Digital Medicine proposes innovative digital and connected solutions as well as services by making the most of collected data, to ensure better individual monitoring of the patient and to better prevent and predict the evolution of the disease mainly in cardiovascular, neurology, diabetes and oncology fields. In an open innovative approach, WeHealth Digital Medicine identifies the most promising start-ups in e-health, in France and internationally, to co-develop solutions. In this way, WeHealth Digital Medicine contributes to the creation of an ecosystem of partners to facilitate and accelerate the development, industrialization and distribution of innovations and to make them accessible to the greatest number.
For further information: https://www.wehealth-digitalmedicine.com/
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1 Sicklick, J. K., Kato, S., Okamura, R., Schwaederle, M., Hahn, M. E., Williams, C. B., De, P., Krie, A., Piccioni, D. E., Miller, V. A., Ross, J. S., Benson, A., Webster, J., Stephens, P. J., Lee, J. J., Fanta, P. T., Lippman, S. M., Leyland-Jones, B., & Kurzrock, R. (2019). Molecular profiling of cancer patients enables personalized combination therapy: the I-PREDICT study. Nature Medicine, 25(5), 744–750. https://doi.org/10.1038/s41591-019-0407-5
2 Boichard, A., Richard, S. B., & Kurzrock, R. (2020). The Crossroads of Precision Medicine and Therapeutic Decision-Making: Use of an Analytical Computational Platform to Predict Response to Cancer Treatments. Cancers, 12(1), 166. https://doi.org/10.3390/cancers12010166
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