NEW YORK (GenomeWeb) – Sophia Genetics said today that it has obtained the CE-IVD Mark for its next-generation sequencing bioinformatics pipeline for routine genetic testing.
The CE-IVD Mark enables the Lausanne, Switzerland-based firm to offer the pipeline in all markets accepting the CE mark in Europe, Latin America, Middle East, Africa, and Asia. Sophia said that it will also seek to obtain the CE Mark for all of the genetic tests it supports.
"The barrier to wider adoption of next-generation sequencing data for the routine genetic testing of patients has historically been the challenge associated with analyzing data," Jurgi Camblong, CEO of Sophia Genetics, said in a statement. "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."
Sophia also noted that it recently received ISO 13485 accreditation, which covers requirements for quality management systems. The firm said that clinical labs using its service " 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."