NEW YORK – Centogene said on Wednesday that it has obtained the CE mark for its cloud-based software-as-a-service platform CentoCloud, which provides clinical decision support for the diagnosis of genetic diseases.
CentoCloud, which is used for the identification, prioritization, and classification of genetic variants, allows laboratories to establish next-generation sequencing-based diagnostic testing. According to the company, it is one of the few examples of CE-marked, cloud-based software for genomic diagnostics.
"With the new IVD regulation going into place later this week, CentoCloud will be one of Europe's only commercialized software on market — underlining our commitment to being at the forefront of offering safe and accessible patient solutions," said Centogene CEO Kim Stratton in a statement, referring to Europe's new In Vitro Diagnostic Regulation (IVDR), which will go into effect May 26.