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 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.”
The most recent validation was completed in March 2021. It involved 500,000 samples, and used whole genome sequencing data sequenced using Illumina technology.
Dante Labs has already received the CE-IVD mark for its Immensa Software in 2020.