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Genomeweb: Platomics Inks Deals With Sophia Genetics, Agilent for Automated IVDR Compliance Documentation

NEWS STORY JANUARY 9, 2025

Jan 09, 2025 | staff reporter 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.

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

New Collaboration JANUARY 9, 2025

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. 

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

New Collaboration JANUARY 8, 2025

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. 

Together we support selected EU clinical labs with regulatory compliance via the PlatoX platform. 

New Collaboration SEPTEMBER 9, 2024

“With IVDR coming into full effect, there is a lot of work that labs have to do in order to comply. Our partnership with Platomics aims to make that process as easy as possible for our customers. Alongside streamlining the documentation process, we look forward to helping the education effort to demystify the IVDR and the road to compliance.” – Amélie Martinez, RAQA Director of Saphetor. 

Hamilton & Platomics

New Collaboration July 17, 2024

We are pleased to announce our collaboration to support diagnostic labs with IVDR technical documentation for their workflows. 

Another innovative manufacturer on board with our mission to transform regulatory via automation and connecting stakeholders – with the aim of bringing innovation to patients, faster.  

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