We've updated our Privacy Policy to make it clearer how we use your personal data.

We use cookies to provide you with a better experience. You can read our Cookie Policy here.

Advertisement
Sophia Genetics Obtains CE-IVD Mark for Bioinformatics Pipeline
News

Sophia Genetics Obtains CE-IVD Mark for Bioinformatics Pipeline

Sophia Genetics Obtains CE-IVD Mark for Bioinformatics Pipeline
News

Sophia Genetics Obtains CE-IVD Mark for Bioinformatics Pipeline

Read time:
 

Want a FREE PDF version of This News Story?

Complete the form below and we will email you a PDF version of "Sophia Genetics Obtains CE-IVD Mark for Bioinformatics Pipeline "

First Name*
Last Name*
Email Address*
Country*
Company Type*
Job Function*
Would you like to receive further email communication from Technology Networks?

Technology Networks Ltd. needs the contact information you provide to us to contact you about our products and services. You may unsubscribe from these communications at any time. For information on how to unsubscribe, as well as our privacy practices and commitment to protecting your privacy, check out our Privacy Policy

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.”

Advertisement