StockMarketWire.com - Molecular diagnostics group Yourgene Health said it had achieved CE-IVD marking for its SARS-CoV-2 test.

The company said the CE-IVD version of its Clarigene test would be used in Yourgene's Covid-19 service lab in Manchester.

It would allow Yourgene to provide corporate partners and healthcare settings, such as care homes and private GP practices, with a fast and reliable COVID-19 lab testing service.

Clinical validation of the test has shown greater 99.9% accuracy with no false positive or false negative results.

Additional studies had shown 100% repeatability data and an average of greater than 99.7% reproducibility.

The company said the CE marked test would be rolled out through its direct sales teams and distribution network and additional submissions were in progress for other regulatory jurisdictions.




Story provided by StockMarketWire.com