Sequoia genetics has received European CE Mark approval for next-generation sequencing solution for diagnostics of inherited diseases in newborns. The company got official notification from MediMark Europe at the end of 2013. Thus the solution named VariFind Neonatal assay is approved for in vitro diagnostics in European Economic Area.

VariFind Neonatal assay is based on the semiconductor sequencing technology and includes reagent kit, assay protocol and specialized software. The assay is intended for diagnostics of two inborn errors of metabolism: cystic fibrosis and galactosemia. Current version of the assay is suitable for detection of 352 clinically-significant mutations in two genes associated with the above diseases. Newborn screening for these diseases is recommended by World Healthcare Organization and is obligatory in Russian Federation and many developed countries.

It should be noted that today VariFind is the only diagnostic assay using semiconductor sequencing technology approved for clinical diagnostics. Efficacy and safety of the assay was demonstrated during extensive clinical trials performed in four European reference laboratories.

CE Mark confirms that the product is in conformity with EU standards for product’s safety. CE Marking was established in Western Europe in the middle of the eighties in order to increase the turnover between the EU countries and to decrease the costs of safety conformation in accordance with EU Directives. CE Mark is usually named as “product’s passport” and allows product realization on the EU market.