SAPHETOR-SA
24.7.2024 09:01:28 CEST | Business Wire | Press release
Saphetor SA, the creators of the global human genetics community VarSome, today announced European CE mark approval of the VarSome Clinical platform for the automated variant discovery, annotation, and interpretation of Next Generation Sequencing (NGS) data in compliance with the European Union’s In-Vitro Diagnostic Medical Devices Regulation (IVDR) (EU Regulation 2017/746 on IVD medical devices) by the notified body TÜV SÜD.
This represents a major milestone in clinical genomics, as robust standards and regulations are introduced to ensure the safety and effectiveness of medical devices. Inclusion of NGS analysis software under IVDR, is a reflection of the maturity of the technology and its importance in clinical practice. With this shift towards routine care, comes the need for transparency and reproducibly reliable performance.
IVDR, which came into full effect on 26 of May 2022, replaces the previous In-Vitro Diagnostic Medical Devices Directive (IVDD) and introduces more stringent requirements for the classification, performance evaluation, and post-market surveillance of in-vitro diagnostic devices. VarSome Clinical’s IVDR certification ensures that it meets the highest standards of safety, performance, and reliability.
As a result of IVDR coming into full effect, in-house tests (also known as Laboratory Developed Tests (LDTs)) or Research Use Only (RUO) products must comply with Article 5.5 of IVDR. This includes in particular the need to implement appropriate quality management systems, comply with the GSPR (General Safety & Performance Requirements) and set up a review process to take necessary corrective actions based on experience gained from the clinical use of the RUO product. At the end of the IVDR transition period, laboratories will no longer be allowed to use a RUO bioinformatics solution if an equivalent IVDR-certified product, such as VarSome Clinical, is commercially available.
Key benefits of VarSome Clinical’s IVDR certification:
- Enhanced safety and performance: VarSome Clinical has undergone rigorous performance evaluations, including scientific validity, analytical performance, and clinical performance, ensuring they meet the stringent requirements set forth by the IVDR.
- Improved risk management: The new risk-based system and comprehensive technical documentation provide a strong framework for identifying and reducing potential risks associated with in-vitro diagnostic devices.
- Strengthened market surveillance: With enhanced post-market surveillance measures, including vigilance reporting and periodic safety updates, Saphetor is committed to continuously monitor the performance and safety of VarSome Clinical.
- Transparency and traceability: Achieving better management of safety related issues and ensuring prompt actions when necessary.
- Regulatory excellence: VarSome Clinical’s IVDR certification demonstrates the dedication of Saphetor for regulatory excellence, providing confidence to healthcare professionals and patients in the quality and reliability of VarSome Clinical as a clinical diagnostic support solution.
Andreas Massouras, CEO and Founder, Saphetor SA, comments:
“The journey to IVDR certification has taken us more than two years. It has taken a lot of hard work across the company, and a lot of planning to put new processes in place. This now sets the new standard that all NGS diagnostic pipelines need to adhere to. Ensuring patient safety, through transparent and robust processes is crucial at this point in time. Genomic data is already having a major impact on healthcare, and so it is now critically important that it meet the standards that the rest of established medical practices have to meet. This is an exciting time, as it shows that genomics is now moving beyond clinical research and into routine clinical care. We are exceptionally proud to be amongst the first bioinformatics platforms to be awarded a CE mark under IVDR, and we look forward to continuing to help advance human health with our VarSome Clinical partners.”
Amélie Martinez, RAQA Director, Saphetor SA, comments:
“This certification is a great achievement and rewards all our efforts in meeting the IVDR requirements, both with the medical device documentation and our Quality Management System. We are proud to be able to provide Healthcare Professionals and diagnostic labs with an IVDR-compliant device, thus reducing their workload for process validation and giving them more time to care for patients.”
About Saphetor SA
Saphetor SA, is a global precision-medicine company dedicated to large-scale identification and interpretation of human genetic variants by leveraging proprietary algorithms and expert domain knowledge.
Saphetor is the creator of VarSome, a suite of intuitive and data-driven bioinformatics solutions both for clinicians and researchers. VarSome.com professional community and search engine is freely accessible, featuring a widely-recognized community-driven knowledge base that enables flexible queries across more than 140 genetic and genomic data resources.
VarSome Premium and VarSome Clinical are professional editions of VarSome with powerful functionality and further sophisticated data-mining and analysis tools. VarSome Clinical is a IVDR-certified and HIPAA-compliant platform allowing fast and accurate variant discovery, annotation, and interpretation of NGS data for whole genomes, exomes, and gene panels, which helps clinicians reach faster and more accurate diagnoses and treatment decisions for genetic conditions. VarSome can also be integrated into existing in-house pipelines via VarSome API through cloud-based or on premises installations.
For more information about Saphetor SA and VarSome Clinical, please visit www.saphetor.com or contact sales@varsome.com.
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