Switzerland-based Sophia Genetics has received CE-IVD mark for its Next Generation Sequencing (NGS) bioinformatic pipeline.
The company has obtained approval for the clinical use of NGS bioinformatic pipeline for routine genetic testing.
Sophia Genetics CEO Jurgi Camblong said the barrier to wider adoption of NGS data for the routine genetic testing of patients has historically been the challenge associated with analysing data.
"At Sophia Genetics we understand the complexity of NGS data and the need to analyse this data to a clinical standard," Camblong added.
Sophia’s software offering dropGen covers the bioinformatic analysis protocol, validation and quality control process, presentation of results of genetic tests to clinicians and the protection of patient DNA sequence data through safe storage and banking.
Sophia noted that it is trying to obtain the CE-IVD mark for all of the genetic tests it supports.
The CE-mark (CE-IVD) allows the device to be legally commercialized and distributed in the EU.