Genomate Health Achieves Certification to ISO 13485:2016

Cambridge, MA – September 10, 2025: Genomate Health, a leading company transforming cancer care through computational reasoning solutions, today announced it has achieved certification to ISO 13485:2016, the international standard for quality management systems in the design and manufacture of medical devices.

The certification, awarded by the British Standards Institution (BSI), covers the design, development, manufacture, installation, and service of in-vitro diagnostic software used in precision oncology. 

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This milestone arrives at a pivotal moment as the company prepares for global expansion. The certification strengthens confidence among healthcare providers, payers, regulators, and patients, ensuring that Genomate Health’s solutions can be integrated into clinical practice while meeting the highest standards of compliance.

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“This certification is a commitment to excellence and safety in everything we build,” said Ioana Stupariu, Chief Administrative Officer & General Counsel, Genomate Health. “ISO 13485 is the foundation that allows us to bring precision oncology software into clinical workflows globally, supporting our next steps toward IVDR certification in Europe and FDA clearance in the United States.”

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ISO 13485 certification represents the highest level of international recognition for quality in medical devices. For Genomate Health, this milestone:

• Validates the quality and rigor of our processes at the highest global standard.
• Strengthens trust with partners, customers, and regulators worldwide.
• Lays the foundation for scaling innovation responsibly while ensuring safety, compliance, and excellence.
• Marks step one in regulatory approval pathways, including IVDR in Europe and FDA in the United States.
  
  

This achievement reflects the commitment of the entire Genomate Health team to delivering excellence and advancing precision oncology responsibly.

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About Genomate Health
Genomate Health Inc. is a medical technology company based in Cambridge, MA, developing computational solutions for personalized medicine. Its flagship product, Genomate®, is the first clinically validated universal computational reasoning model to predict response to multiple targeted therapies by analyzing each patient's unique combinations of genetic alterations and biomarkers. Genomate® delivers the first computational reasoning solution to implement the true promise of precision oncology of N-of-1 therapy based on the genomic profile of the patient’s tumor. The result is presented as a comprehensive, data-backed report that guides oncologists and patients toward the most suitable treatment, enhancing the efficacy of therapies. A key contributor to the White House-led CancerX initiative, a graduate of the Mayo Clinic Accelerate Program, and a member of the Precision Medicine Coalition, Genomate Health remains steadfast in its mission to democratize precision oncology worldwide. 

For more information, visit www.genomate.health

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About BSI
Since 1901, BSI has been creating an enduring legacy of transformation for the benefit of all. Across all divisions and services, BSI delivers on its purpose by helping its clients to fulfil theirs. For over a century, BSI has driven best practice in organizations around the world and supports a 13,000-strong global community of experts. With extensive expertise in standards, Assurance, Regulatory, and Consulting services, BSI supports organizations to enhance performance, achieve sustainable growth, manage risks, and be a partner in progress.

For more information, please visit: bsigroup.com

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Media Contact

Alina Luchian
Marketing & Brand Manager, Genomate Health Inc
alina.luchian(at)genomate.health