Congenica, the digital health company enabling rapid and accurate analysis of complex genomic data to transform people’s lives, today announces that its genomic interpretation software is now CE marked under the In Vitro Diagnostics Directive (98/79/EC).

With the In Vitro Diagnostic (IVD) designation, Congenica’s clinical decision support platform can make the transition from research to clinical use and be applied to the clinical diagnosis of patients with rare hereditary genomic disorders. The platform is the only CE marked IVD software for genomic diagnostics that is available either on a local infrastructure or via the cloud and can be fully integrated with existing medical records and laboratory management systems. Medical devices require the CE mark designation for use in clinical applications in several key territories including the UK and the EU.

Congenica’s world-leading genomic analysis technology platform supports the delivery of personalised medicine at scale, enabling rapid and accurate diagnoses for patients. While genomic sequencing is becoming more routine and affordable, a sequence is only useful if it can be interpreted, to support a diagnosis and guide treatment decisions. By enabling the rapid analysis and interpretation of genomic data on a massive scale, Congenica is helping to build a future where genomic medicine is incorporated into routine care, delivering life-changing answers for patients around the world.

Dr David Atkins, Chief Executive Officer, Congenica:

“This is a significant milestone for Congenica as we expand into new markets as part of the ongoing international rollout of our software platform. With the CE mark designation, our customers can now use our product for the diagnosis of genetic diseases as part of standard care, bringing us closer to our vision of genomic medicine being routinely incorporated into clinical practice at a global scale.”

As a CE marked IVD, all aspects of Congenica’s genomic interpretation software adhere to comprehensive security protocols and have been developed to meet international standards for quality management systems and all relevant data privacy regulations.

Jonathan Day, Senior Director of Regulatory Affairs and Quality Assurance, Congenica: “Obtaining the CE mark is testament to the quality of Congenica’s software platform and provides clear validation of our compliance with best practice industry standards. As the regulatory landscape continues to evolve, we are committed to remaining ahead of the game with regards to meeting the strong requirements in our industry with this focus on patient safety being vital for enabling genomic medicine at scale.”