NEW YORK – Congenica said Wednesday that it has obtained CE-IVD marking for its genomic data analysis and clinical decision support technology.
The Cambridge, UK-based company makes a modular and scalable data analytics tool for annotating and clinically interpreting genomic sequence data to support clinical decision-making. The CE designation allows Congenica to apply its software to clinical diagnosis of rare hereditary disorders.
"This is a significant milestone for Congenica as we expand into new markets as part of the ongoing international rollout of our software platform," CEO David Atkins said in a statement. "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."
Indeed, Congenica has been widening its global footprint this year. In April, the firm entered into a partnership with Camtech Diagnostics to market and distribute its software in Singapore, Malaysia, Japan and South Korea. A month earlier, the company announced a distribution agreement with Amplitech to distribute its products in France and other French-speaking European countries.