This collaboration will provide selected EU clinical laboratories with a digital solution for meeting IVDR documentation requirements for in-house NGS workflows.
Lausanne, Vienna, September 2024 — Saphetor, creator of VarSome and the CE-IVD NGS bioinformatic analysis tool VarSome Clinical, and regulatory automation provider Platomics have teamed up to offer selected EU clinical labs an efficient regulatory platform for documenting and validating their in-house NGS tests in compliance with the EU’s strict In Vitro Diagnostic Regulation (IVDR).
Since the latest phase of implementation came into full force in May 2024, IVDR Article 5.5 documentation requirements for in-house in vitro diagnostic devices (IH-IVDs) are quite extensive, particularly for complex NGS workflows and especially those falling into the highest risk classes.
This initiative will benefit Saphetor’s lab customers by streamlining and guiding their compliance work on a digital regulatory platform featuring structured files, integrated guidance and rules-based automation.
The PlatoX® platform also enables labs instant access to essential product data for Saphetor analysis tools for completing the technical documentation of their in-house tests. Relevant Saphetor product data is automatically integrated into the labs’ workflow documentation on the platform. Workflows can then be validated with support from the PlatoX® validation module.
The collaboration will also encompass educational activities including a webinar dedicated to resolving the challenges IVDR poses for labs performing genetic testing.
“With IVDR coming into full effect, there is a lot of work that labs have to do in order to comply. Our partnership with Platomics aims to make that process as easy as possible for our customers. Alongside streamlining the documentation process, we look forward to helping the education effort to demystify the IVDR and the road to compliance,” said Amélie Martinez, RAQA Director of Saphetor.
“Platomics is thrilled to work together with Saphetor to ensure that labs using their analysis tools can easily document and validate their workflows—whether working with new assays or updating existing ones. Our platform provides orientation and guidance, enabling labs to get the regulatory work done more efficiently,” said Albert Kriegner, CEO of Platomics.
About Platomics
Platomics automates regulatory processes and connects in vitro diagnostic manufacturers, laboratories and regulators to accelerate compliance and bring innovation to patients faster. The PlatoX® platform saves time, resources and costs for all stakeholders involved in IVDR compliance by digitalizing regulatory work on the basis of intelligent data, not docs.
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 Clinical is a platform allowing variant discovery, annotation, and interpretation of NGS data for whole genomes, exomes, and gene panels.
For more information about Saphetor SA and VarSome Clinical, please visit www.saphetor.com or contact sales@varsome.com.
Contact
Carl Smith
Director of Marketing and Communications
Saphetor