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

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

CAMBRIDGE, England–(BUSINESS WIRE/AETOSWire)– 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 is a great achievement for all of the team members at Dante Labs who worked very hard to implement a brand-new ISO-compliant…