Cancer treatment
should be
personalized

About ONCOGENE®

Oncogene SRL (Chisinau, Republic of Moldova) is the authorized partner of Molecular Health GmbH in Moldova, Ukraine, Russia, Belarus, Azerbaijan, Turkmenistan, Kazakhstan, Tajikistan, Georgia, Armenia, Kyrgyzstan and Romania (service area).
The company runs ONCOGENE®, a specialized interactive service that provides medical oncologists with the ability to clinically interpret the genomic profile of solid patient malignancies to support the best clinical decisions in choosing potentially effective and safe anticancer drug treatment protocols.
ONCOGENE® service organizes the process of ordering, payment, collection, delivery, DNA sequencing of the tumor, bioinformatics and clinical interpretation of the genomic profile of cancer patients, as well as professional support for medical oncologists throughout the service.

About Molecular Health

Molecular Health GmbH (Heidelberg, Germany) – a leading company in the field of computational biomedicine, which collects, integrates and analyzes biomedical data and knowledge to provide precision medicine (data science for precision medicine). The company provides comprehensive medical and therapeutic services to a wide range of clients, including doctors, hospitals, research networks, laboratories, regulatory authorities and pharmaceutical companies, using in-depth exploration of big data. For over 10 years, the company has been developing its own Dataome® cloud technology platform and Molecular Health Guide® (MH Guide) software using the SAP HANA platform, artificial intelligence technology and machine learning. Official company source – www.molecularhealth.com MH Guide® – the first software product registered in Europe as an In Vitro Diagnostic medical device (CE-IVD) to analyze and interpret patient genomic data to select a potentially effective and safe anticancer drug treatment. The MH Guide® supports cancer treatment decision making with the highly reliable Dataome knowledge database.

 

Примечание

Генетическая информация о наследственной предрасположенности к определенным заболеваниям не является частью анализа.

MH Guide® непрерывно оптимизируется с помощью клинической валидации в исследованиях, а также непрерывного профессионального взаимодействия с ведущими мировыми онкологическими центрами.

Анализ MH Guide® основывается на данных о раковых клетках, которые были полученны путем секвенирования генетического материала. В зависимости от типа опухоли и стадии, существуют различные потенциальные процедуры.

✕

Molecular Health GmbH has authoritative international certifications and accreditations

  • IVD: Directive 98/79/EC of the European Parliament and of the Council on In Vitro Diagnostic medical devices 1
  • CE: EC Declaration of Conformity Molecular Health Guide®
  • ISO: DIN EN ISO 13485:2016 (Quality Management System for the Design and Manufacture of Medical Devices throughout the world).MM
  • MDSAP: Medical Device Single Audit Program (Design and Development, Manufacture, Installation and Servicing of In-Vitro Diagnostic Software used in Genetic Testing For the Diagnosis of Hereditary Diseases or Predispositions to a Medical Condition or a Disease and Prediction of Treatment Response including Point of care In-Vitro Diagnostic Medical Devices.
  • CLIA: US Clinical Laboratory Improvement Amendments (CLIA), which are issued by the US Federal Agency Centers for Medicare and Medicaid Services (CMS).
  • CAP: College of American Pathologists (CAP), which means it complies with US laboratory standards to ensure the proper validity, handling and reporting of dry-laboratory results.

Molecular Health GmbH adopts industry-leading security standards and practices for various aspects of privacy and data security management.


  • BDSG: Bundesdatenschutzgesetz, German (Federal Law on the Protection of Personal Data, Germany).
  • BDSG: Gendiagnostik-Gesetz, German (Federal Law on Genetic Diagnostics, Germany).
  • HIPAA: Health Insurance Portability and Accountability Act, USA (US Health Insurance Mobility and Liability Act (Act)).

Data transfer: clinical data and patient information are encrypted during transmission and storage using advanced encryption standards (SSL / TLS, AES-256). All services are located in data centers certified according to ISO 27001.

Data storage: data privacy guarantee.

Data access: access to patient data is fully controlled and monitored.

Data Center Architecture: cloud data centers accredited in accordance with ISO 27001 and meet the highest industry standards for data security.

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