Platomics and Agilent Technologies Enter into a Pilot Project Agreement to Streamline IVDR Documentation for NGS Testing

Vienna, Austria, January 9, 2025 – Regulatory automation provider Platomics has announced a pilot program with Agilent Technologies Inc. (NYSE: A) to enhance laboratory documentation capabilities for next-generation sequencing (NGS) tests under the European Union’s In Vitro Diagnostic Regulation (IVDR).   

This agreement enables Agilent customers to leverage Platomics’ PlatoX® platform for generating comprehensive documentation required for IVDR compliance. This digital solution automates and accelerates IVDR compliance documentation for laboratory workflows with intuitive wizards, templates, and rules-based automation.   

On the PlatoX® platform, laboratories can create structured, audit-ready files for key IVDR requirements, including the General Safety and Performance Requirements (GSPRs) and risk management aligned with ISO 22367. The platform connects labs and manufacturers to automate the exchange of product data and simplify regulatory processes between stakeholders, greatly streamlining and expediting the compliance path. 

The pilot program emphasizes direct customer engagement and feedback integration to optimize solution development. During the program, Agilent will systematically evaluate customer experiences and adapt offerings to address specific market needs in the evolving regulatory landscape. The platform provides orientation and guidance, enabling laboratories to complete regulatory work more efficiently. 

“This collaboration represents a significant step in our commitment to supporting clinical laboratories navigating IVDR requirements,” said Ronda Allen, General Manager, Genomics Division at Agilent Technologies. “By starting with our NGS portfolio, we’re establishing a foundation that could potentially extend across our broader diagnostic solutions.” 

“We are proud to have Agilent aboard the PlatoX platform, working together with us to help laboratories ensure and document conformity and the overall quality of their work. Our digital solutions offer an efficient and easy-to-use pathway to compliance,” said Albert Kriegner, CEO of Platomics. 

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

Christina White, PhD 
Communications