 now fully in effect as of May 2024, clinical laboratories face stringent documentation and validation requirements){kind=link}
With the European Union’s updated In Vitro Diagnostic Regulation (IVDR) now fully in effect as of May 2024, clinical laboratories face stringent documentation and validation requirements for in-house diagnostic tests, particularly for complex next-generation sequencing (NGS) workflows. In response to these challenges, bioinformatics company Saphetor and regulatory automation provider Platomics have announced a partnership to streamline compliance efforts for selected clinical labs across the EU.
The collaboration aims to simplify the extensive regulatory documentation process required by IVDR Article 5.5, which applies to in-house in vitro diagnostic devices (IH-IVDs). This is especially crucial for high-risk tests using NGS, a widely-used method in genetic testing.
By integrating Saphetor’s VarSome Clinical NGS analysis tools with Platomics’ PlatoX® digital regulatory platform, the initiative will help clinical labs efficiently document and validate their in-house tests. The platform provides structured files, integrated guidance, and automation to ensure that labs can meet regulatory requirements with ease.
A key feature of the partnership is the automatic integration of Saphetor’s product data into lab documentation workflows on the PlatoX® platform. This allows labs to instantly access essential data for their tests, ensuring accurate and compliant technical documentation. Additionally, labs can validate their workflows using the platform’s dedicated validation module.
The collaboration will also extend to educational outreach, including a webinar aimed at helping labs navigate the complexities of the IVDR and streamline their compliance processes.
“IVDR compliance places significant demands on clinical labs, especially in the genetic testing field,” said Amélie Martinez, RAQA Director at Saphetor. “Our partnership with Platomics aims to make the documentation process easier while offering educational resources to help labs better understand and navigate these new regulations.”
Albert Kriegner, CEO of Platomics, echoed this sentiment: “We are excited to work with Saphetor to ensure labs can document and validate their workflows with ease, whether they are developing new assays or updating existing ones. Our platform offers the orientation and guidance labs need to efficiently manage their regulatory tasks.”
The partnership between Saphetor and Platomics offers clinical labs a streamlined and tech-driven solution to meet the increasingly complex regulatory demands of genetic testing under the IVDR.
Saphetor is known for its precision-medicine technologies, including VarSome, a bioinformatics platform that supports clinicians and researchers with tools for genetic variant discovery and interpretation. Meanwhile, Platomics specializes in automating regulatory processes for in vitro diagnostic manufacturers and laboratories, helping them meet compliance faster and more efficiently.