Product News: First European Company Obtains CE-IVD Mark for Clinical Use of Next Generation Sequencing Bioinformatics Pipeline

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 a 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.”

About ISO 13485

ISO 13485:2003 specifies requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

About CE-IVD

The CE-mark (CE-IVD) 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.