-

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

original Dante Labs Automatic Lab (Photo: Business Wire)

Dante Labs Automatic Lab (Photo: Business Wire)

CAMBRIDGE, England--(BUSINESS WIRE)--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.

About Dante Labs

Dante Labs is a global genomic platform that integrates genomic and clinical data to provide better solutions in both diagnostics and therapeutics. Dante Labs’ genomic applications have an impact in the lives of patients and doctors, from rare diseases and oncology, to infectious diseases. To learn more, please visit www.dantelabs.com and follow @DanteLabs.

Contacts

Giorgio Lodi
giorgio.lodi@dantelabs.com

Industry:

Dante Labs

Details
Headquarters: New York, USA
CEO: Andrea Riposati
Employees: 42
Organization: PRI
Release Summary
Dante Labs achieves ISO 13485, leveraging an 18 month long clinical validation study of 500,000 samples.
Release Versions
English
Hashtags
#genomics
#sequencing

Contacts

Giorgio Lodi
giorgio.lodi@dantelabs.com

More News From Dante Labs

No one listened. Then a Dante Labs Whole Genome Report Gave a Single Mother's Two Children a Name for Their Disease and Access to the Specialists They Needed

NEW YORK--(BUSINESS WIRE)--For years, Susan watched her two children collapse without warning. Episodes of sudden, full-body muscle weakness that came and went — sometimes lasting minutes, sometimes hours. Between episodes, they looked like any other healthy kids. And that was the problem. Susan, a single mother in a small town in New Zealand, took her children to doctor after doctor. Blood panels came back normal. She was told the symptoms were stress-related. No referrals. No follow-up. No an...

Trieste, L'Aquila, Rome: the Italian genomics triangle assembles the new diploid RPE-1 genome, the missing piece for CRISPR, immediately published in California and on Nature magazine – with Dante Labs, Area Science Park, and La Sapienza University

ROME--(BUSINESS WIRE)--A few weeks ago, the USCS Genome Browser at the University of California, Santa Cruz, the bible of reference genomics, published a new and very important reference genome, Diploid RPE-1, key to the study of centromeres, thanks to the work of the Area Science Park in Trieste, the Giunta Lab at Sapienza University, Dante Labs, and the University of L'Aquila. These innovative Italian institutions have formed an international alliance with Rockefeller University in New York a...

From Blurry to 4K DNA: Dante Omics AI, Rockefeller University, Giunta Lab and Global Partners Assemble the Most Complete Genome for the RPE-1 Cell Line – the Standard for Complex Cell Engineering Experiments

NEW YORK--(BUSINESS WIRE)--Dante Omics AI, Rockefeller University, Giunta Lab, Sapienza University, University of Tennessee, Trieste Area Science Park and University of L’Aquila published the successful assembly of a near-complete human diploid reference genome for one of the world’s most widely used cell lines. This breakthrough provides a reference-quality blueprint of the RPE-1 cell line, a workhorse in laboratories around the globe. Dante Omics leveraged its expertise with the Dante Labs ge...
Back to Newsroom