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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.