Dante Labs IMMENSA Receives CE-IVD Mark for Whole Genome Data Interpretation Based on Study of Over 150,000 Cases
Dante Labs received CE-IVD Mark for its IMMENSA Software for interpretation of whole genome sequencing data in a clinical setting at scale. IMMENSA was built leveraging more than 150,000 genomic reports generated by Dante Labs for its users and patients and then integrated user feedback. The company’s U.S. and European advisors provided clinical insights.
IMMENSA generates reports for Pharmacogenomics, Rare Diseases, predisposition to Common Diseases, Nutrigenomics and integrates ACMG 59 guidelines.
Thousands of Rare Disease patients around the world have already benefited from IMMENSA, receiving personalized reports which have enabled their doctors to make data-driven decisions not only about the diagnosis but also about the best treatment to use.
IMMENSA takes about 30 seconds to generate a report, scales elastically with demand, running reports in parallel on its AWS infrastructure (Amazon Web Services).
“The CE Mark is an important achievement, highlighting our commitment to quality standards and the regulatory environment,” said Dante Labs CEO Andrea Riposati. “IMMENSA will be available as a commercial software to clinics and hospitals in a few weeks.”
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