SeqOne, a leading provider of AI-powered genomic data analysis solutions, and regulatory automation provider Platomics have teamed up to offer EU clinical labs an efficient regulatory platform for documenting and validating their NGS workflows 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.
The collaboration between SeqOne and Platomics will offer laboratories a powerful combination and flexible options to meet the stringent requirements of IVDR Article 5.5 across multiple use cases such as Germline panels, exomes, genomes and Somatic DNA, RNA, ctDNA and HRD analysis.
The PlatoX® platform also enables labs to have instant access to essential product data for SeqOne analysis tools to complete the technical documentation of their in-house tests. Relevant SeqOne 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.
“We are excited to partner with Platomics to offer genetic testing laboratories a flexible and robust solution for IVDR compliance,” said Martin Dubuc, CEO of SeqOne. “With this partnership, we can provide labs with additional options and tools they need to navigate the complex regulatory landscape while maintaining the highest standards of patient care.”
Albert Kriegner, CEO of Platomics, added, “This partnership with SeqOne represents a significant step forward in supporting laboratories as they adapt to the new IVDR requirements. Together, we can offer a comprehensive solution that not only supports compliance but also enhances the overall efficiency and quality of genetic testing services.”
The integrated SeqOne-Platomics solution is expected to be available to customers in the coming weeks.
For more information about this partnership and how it can benefit your laboratory, please visit www.seqone.com or www.platomics.com.
About SeqOne Genomics
SeqOne Genomics is a leading provider of AI-powered genomic data analysis solutions, offering a platform that enables fast, accurate, and scalable analysis of genetic data. With a focus on rare diseases and oncology, SeqOne’s technology helps healthcare providers deliver personalized medicine to patients worldwide.
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.
Source: seqone.com/news/seqone-and-platomics-join-forces-to-support-labs-with-ivdr-compliance/