January 10, 2025
Jan 09, 2025 | genomeweb
NEW YORK – Regulatory compliance software provider Platomics said Thursday that it has launched a pilot program with Agilent Technologies to offer customers laboratory documentation capabilities for next-generation sequencing tests developed under the European Union’s In Vitro Diagnostic Regulation (IVDR).
Separately, the Vienna-based firm said Wednesday that it has inked a partnership with Sophia Genetics to streamline the compliance documentation process for EU clinical laboratories developing NGS tests using Sophia’s products.
Financial details for the two deals were not disclosed.
Through the collaboration, Agilent customers developing NGS tests can leverage Platomics’ PlatoX platform to generate documentation required for IVDR compliance in an automated fashion. Agilent will evaluate customer experiences and adapt its offerings to address specific market needs.
“This collaboration represents a significant step in our commitment to supporting clinical laboratories navigating IVDR requirements,” Ronda Allen, general manager of Agilent’s genomics division, said in a statement. “By starting with our NGS portfolio, we’re establishing a foundation that could potentially extend across our broader diagnostic solutions.”
Similarly, Sophia’s collaboration allows its customers to gain access to PlatoX, which will register Sophia’s products to provide users instant access to essential product data needed to complete the technical documentation for their tests.
“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,” Kevin Puylaert, Sophia’s managing director of Europe, the Middle East, and Africa, said in a statement.