Sophia Genetics receives CE-IVD mark for genetic testing of Familial Mediterranean Fever and Hypercholesterolemia
Sophia Genetics, the European leader in NGS data analysis, has received the CE-IVD mark for genetic testing of Familial Mediterranean Fever and Hypercholesterolemia.
The quality assurance guarantee for these three tests follows receipt of CE-IVD certification for Sophia’s NGS bioinformatics pipeline for use in routine genetic testing, further strengthening standards of testing and clinical diagnosis of congenital diseases.
Sophia Genetics’ CE-IVD and ISO 13485-accredited Data Driven Medicine platform reduces the cost and time associated with compliance for clinical laboratories with both the new CE-IVD Directive as well as the requirements for ISO 15189 accreditation. As part of its commitment to quality, Sophia Genetics will seek to obtain the CE-IVD mark for each of the genetic tests it supports.
Jurgi Camblong, CEO of Sophia Genetics, said:
“Data Driven Medicine is transforming our ability to address congenital diseases. But there is a real need for solutions which can analyse the data produced by NGS sequencing to a clinical standard. At Sophia Genetics, we are dedicated to solving some of the toughest problems in data analysis and making clinical diagnosis much simpler, faster and easier for our lab customers.”
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.