Shortly after receiving ISO 13485 accreditation, Sophia Genetics has become the first European company to obtain a CE-IVD mark for the clinical use of an Next Generation Sequencing (NGS) bioinformatic pipeline for routine genetic testing. This quality assurance certification represents an important step in raising the standards of routine genetic testing and clinical diagnosis, and brings Sophia Genetics’ world-leading Data Driven Medicine platform to a wider market.
The certification also means that Sophia Genetics’ proven quality assurance methodology can now be leveraged by clinical laboratories to meet their own quality assurance requirements. Using Sophia Genetics’ service, clinical laboratories gain access to quality assurance expertise, facilitating both cost-saving and time-efficient filing for ISO 15189 accreditation and compliance with the new CE-IVD Directive. Sophia Genetics will seek to obtain the CE-IVD mark for all of the genetic tests it supports.
Jurgi Camblong, CEO of Sophia Genetics, said:
“The barrier to wider adoption of Next Generation Sequencing (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. We have designed solutions to address even the most difficult data analysis problems that existing bioinformatics software programs are not able to solve, making NGS genetic testing much simpler, faster and easier for our lab customers.”