First European Company Obtains CE-IVD Marking for Next Generation Sequencing in Routine Testing

ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet applicable customer and regulatory requirements. The CE-IVD marking indicates that an IVD device complies with the European In Vitro Diagnostics Directive (98/79/EC), and that the device may be legally commercialized and distributed in the EU. This quality assurance certification represents an important step in raising standards, and brings Sophia Genetics’ 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 the CE-IVD marking for all genetic tests it supports.

Jurgi Camblong, CEO of Sophia Genetics, said, “The barrier to wider adoption of NGS data for the routine genetic testing of patients has historically been the challenge associated with analyzing data. At Sophia Genetics we understand the complexity of NGS data and the need to analyze 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.”

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