SOPHiA GENETICS and Platomics Announce Collaboration to Support EU Clinical Labs with IVDR Compliance

Regulatory automation platform eases the burden of documenting NGS workflows 

Vienna, Austria and Rolle, Switzerland, January 8, 2025 – SOPHiA GENETICS (Nasdaq: SOPH), a cloud-native healthcare technology company and a leader in data-driven medicine, and regulatory automation provider Platomics are collaborating to streamline compliance for EU clinical laboratories using SOPHiA GENETICS’ products. This initiative introduces an efficient digital solution for documenting NGS workflows to meet the requirements of the EU In Vitro Diagnostic Regulation (IVDR).  

With IVDR Article 5.5 now in full force, clinical laboratories must provide extensive regulatory documentation, particularly for complex NGS workflows that fall into the highest risk classes. Labs are often challenged to manage the time, expertise, and resources necessary to meet these rigorous regulatory demands. 

Through this initiative, SOPHiA GENETICS’ customers will benefit from the PlatoX® platform, which offers structured files, integrated guidance, automation and a regulatory knowledge-base. The platform enables laboratories to quickly navigate the new requirements and maintain compliance over the lifecycle of their tests.  

SOPHiA GENETICS’ products will be registered on the PlatoX® platform to provide labs instant access to essential product data needed to complete the technical documentation for their tests. Rules-based automation ensures that the relevant product data is integrated where needed in audit-ready reports created on the platform. NGS workflows can then be validated with support from the PlatoX® validation module. 

“At SOPHiA GENETICS, we pride ourselves in offering a broad range of IVDR-compliant, cutting-edge applications for our customers’ analytical needs. Partnering with Platomics is a natural next step for us to ensure end-to-end workflows that are fully documented and validated according to IVDR standards,” said Kevin Puylaert, Managing Director, EMEA, SOPHiA. 

Albert Kriegner, CEO of Platomics: “It is a privilege and an incredible opportunity for us to work together with SOPHiA GENETICS to support clinical labs in efficiently demonstrating the quality of their innovative and routine genetic tests. Our digital platform makes it easier to keep up with regulatory requirements and apply standards that can ultimately lead to better testing.” 

This solution is expected to be available to customers in the coming weeks. 

About SOPHiA GENETICS 

SOPHiA GENETICS (Nasdaq: SOPH) is a cloud-native healthcare technology company on a mission to transform patient care by expanding access to data-driven medicine globally. It is the creator of the SOPHiA DDM™ Platform, which analyzes complex genomic and multimodal data and generates real-time, actionable insights for a broad global network of hospital, laboratory, and biopharma institutions. For more information, visit SOPHiAGENETICS.com and connect with us on LinkedIn.  

Contact SOPHiA GENETICS 
Kelly Katapodis 
Communications 

About Platomics 

Platomics  automates regulatory processes and connects in vitro diagnostic manufacturers and laboratories 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. For more information contact us or connect with us on LinkedIn

Contact Platomics
Christina White, PhD 
Communications