PubGene’s digital health platform for personalised medicine, Coremine Vitae, obtained the CE-mark Class I Medical Device, ensuring that it complies with all the relevant Essential Requirements of the Medical Devices Directive – 93/42/EEC MDD and subsequent amendments.
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Finding personalised treatment options
Coremine Vitae is intended to aid in the personalised and shared clinical decision. It is indicated for patients with cancer, autoimmune and neurodegenerative diseases. The medical device leverages the power of precision medicine, digital health, and AI to enable healthcare institutions to find the best possible treatment for their patients. It promotes the value-based selection of molecular and genomic testing, performs bioinformatic analysis of the results in consideration of the latest scientific knowledge available combined with patient- and disease specific characteristic and preferences, and provides multiple quality control checkpoints. The secure communication between patients, clinicians and bioinformaticians, and the collection of patient-specific data and real-world outcomes is facilitated by a collaboration and remote monitoring module. Coremine Vitae will also provide APIs and a team of trained experts for easy integration with the local health information systems in place.
Coremine Vitae is now open for business in EU
This CE-mark certification is an important milestone. It will allow PubGene to market the device in Europe and other CE Mark regions. We are excited for this opportunity to make our Clinical Decision Support and Bioinformatics analysis system available to hospitals. Our system provides them with a unified, AI-assisted, and evidence-based process to leverage the availability of multi-omics technologies incl. NGS, and to respond to the rapid growth of healthcare data. This will yield the reduction of unnecessary treatment and improvement of the effectiveness of the healthcare team.
The result of preclinical studies with clinicians, patients, and subject matter experts
This CE-certification is the result of a year-long collaboration with clinicians, patient representatives and subject matter experts to design actionable, ethical, and collaborative personalised medicine insight reports. We are proud of the tremendous efforts from our R&D team, who got trained to apply standard-based methodology in Medical Device Design and Manufacturing (EN ISO 13485:2016), Risk Management (EN ISO 14971:2012), Software Life-cycle (EN 62304:2006) and Usability Engineering (EN 62366-1:2015). The team carefully documented the inputs, decision rules and outputs of each step of the AI, the standardized procedures of its end-users (SOPs), the quality indicators and surveillance processes. We designed a microservices-based software architecture that enables robustness and software team scalability, and that provides clear interfaces to the patented algorithms of PubGene’s Core platform. We switched to an Agile development methodology, making our team responsive to the evolving healthcare market needs.
This achievement was made possible thanks to the unique combination of competence of our R&D team, who comprises molecular researchers, bioinformaticians, engineers and marketing strategist, and PubGene’s partnerships with medical research centers, patient associations, private clinics and reputable oncologists.
We are enthusiastic about Coremine Vitae’s potential in clinical settings.
Safety, quality, and clinical value by design
For digital health solutions to have greater impact, their quality and value must be easy to distinguish. This certification process of Coremine Vitae enabled us to demonstrate a clear therapeutic objective driven by high quality software and standard operating procedures.
Our manufacturing process is guided by end-user needs and formal technical, clinical, and usability assessments. It provides the transparency necessary for an objective assessment of our product. This will therefore facilitate its adoption by healthcare institutions and reduce efforts from integration partners.
Coremine Vitae Intended use: To aid in personalised and shared clinical decision-making
- PM: Personalized Medicine
- AI: Artificial Intelligence
- MDD: the Medical Device Directive 93/42/EEC
- EMR: Electronic Medical Records
- NGS: Next-Generation Sequencing
- NLP: Natural Language Processing
- CBR: Case-Based Reasoning
- mHealth: mobile health