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Congenica announced Wednesday that its genomic interpretation software received the CE mark under the in vitro diagnostics (IVD) directive, allowing it to be applied to the clinical diagnosis of patients with rare hereditary genomic disorders. CEO David Atkins said "this is a significant milestone for Congenica as we expand into new markets as part of the ongoing international rollout of our software platform."
Congenica noted that the platform is the only CE-marked IVD software for genomic diagnostics that is available on a "local infrastructure or via the cloud and can be fully integrated with existing medical records and laboratory management systems." The company suggested its technology allows for the rapid analysis and interpretation of genomic data "on a massive scale," helping to incorporate genomic medicine into routine care in the future (for related analysis, see One To Watch: Congenica seeks to make genomic analysis "simple and routine").
Earlier this year, Congenica announced a collaboration with University of Glasgow spin-out Gabriel Precision Oncology to develop a highly automated somatic cancer clinical interpretation software platform that it said would support the use of multiple genomic assays in routine clinical practice.
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