4bases and Platomics partner up to facilitate laboratory workflow
documentation under IVDR

Manno, Switzerland, and Vienna, Austria – 25.02.2025

4bases SA, a Swiss company specializing in NGS reagent kits and bioinformatics tools, and regulatory automation provider Platomics GmbH are delighted to announce a strategic agreement aimed at facilitating laboratory regulatory documentation according to the EU’s In Vitro Diagnostic Regulation.

Clinical laboratories using 4bases products can efficiently navigate regulatory documentation on Platomics’ PlatoX® platform. PlatoX® streamlines the generation of documentation for laboratory workflows through automation, templates and integrated guidance.

With PlatoX®, laboratories can create structured digital files covering for example workflow specifications, General Safety and Performance Requirements (GSPRs) and/or risk management in accordance with ISO 22367. The platform enables automated access to essential manufacturer product data, allowing labs to quickly generate documentation for their laboratory Quality Management System.

Fabio Grandi, CEO of 4bases, said: “As quality and compliance documentation becomes more and more important, we are convinced that our current and future customers will strongly benefit from this new strategic collaboration.”

Albert Kriegner, CEO of Platomics, said: “4bases and Platomics are working together to make it easier for labs to offer innovative tests with demonstrated quality that meet the highest standards and fulfill the regulatory requirements.”

About 4bases

4bases is a Swiss-based company with a production facility in Italy, specializing in the development, production, and commercialization of clinically validated diagnostic purpose reagent kits for NGS. It was launched in 2013 to address increasing medical needs in the fields of prevention and precision medicine. 4bases is an ISO13485:2016 certified company whose mission is to offer clinically validated and cost-effective solutions to healthcare professionals who perform or rely on diagnostic genetic tests. 4bases’ vision is that precision medicine will continue to develop significantly and the need for clinically validated diagnostic genetic tests for somatic and germinal analyses will strongly increase. 4bases is therefore continuously developing new solutions and addressing the evolving regulatory needs. 4bases plan is to accelerate its development program through technological, regulatory, and commercial partnerships.

Contact: info@4bases.ch

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