Saphetor SA receives IVDR Certification for clinical diagnosis support NGS data analysis platform, VarSome Clinical, ensuring enhanced safety and performance standards
2024年7月24日 - 4:00PM
ビジネスワイヤ(英語)
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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Carl Smith Director of Marketing and Communications Saphetor
Carl.Smith@saphetor.com