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Dante Labs achieves ISO 13485 certification for its Genomic Interpretation Software Immensa, leveraging an 18 month long clinical validation study of 500,000 samples


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Dante Labs, a world leader in genomic sequencing and data analysis, announced today that it received ISO 13485:2016 certification for its Immensa Genomic Interpretation Software as a medical device. The highly coveted industry certification involved a deep clinical validation study carried out by several teams at Dante Labs over an 18 month period. The accreditation was awarded by The British Standards Institution (BSI) Group.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210405005027/en/
Dante Labs Automatic Lab (Photo: Business Wire)
This is a great achievement for all of the team members at Dante Labs who worked very hard to implement a brand-new ISO-compliant quality system and develop the software, says Dante Labs CEO Andrea Riposati. The bioinformatics team ran a clinical validation study the size of a population genomics program. ....

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Detailed text transcripts for TV channel - MSNBC - 20120928:09:14:00

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