Original from: 360dx

Switzerland's Saphetor said Wednesday that it has received CE marking for VarSome Clinical, its genome interpretation platform.

The software offers automated variant discovery, annotation, and interpretation of next-generation sequencing data. In a statement, the firm said the certification under the EU's In Vitro Diagnostic Medical Devices Regulation is more stringent than the previous process, and its product has improved risk management, enhanced performance and safety monitoring, and better transparency. 

"This now sets the new standard that all NGS diagnostic pipelines need to adhere to," Saphetor CEO and Founder Andreas Massouras said in a statement, noting that the process of getting regulatory clearance took more than two years. "This is an exciting time, as it shows that genomics is now moving beyond clinical research and into routine clinical care. We are exceptionally proud to be amongst the first bioinformatics platforms to be awarded a CE mark."

Saphetor launched VarSome in 2016.

Source: Saphetor Receives CE Mark for VarSome Clinical Software Platform