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Yourgene Health SARS-CoV-2 Test Receives CE-IVD Mark

NEW YORK – Yourgene Health said on Monday that its Clarigene SARS-CoV-2 in vitro diagnostic kit has received the CE-IVD mark for diagnostic use.

The IVD version of the test will be used in Yourgene's high-throughput COVID-19 service lab in Manchester, UK. The test is an RT-qPCR assay, which detects the presence of SARS-CoV-2 viral RNA. It uses two viral RNA targets, nucleocapsid gene N and envelope gene E, which are specific to COVID-19, preventing cross reaction with other coronaviruses, Yourgene said.

In clinical validation, the test achieved greater than 99.9 percent accuracy with no false-positive or false-negative results, it added, while additional studies demonstrated 100 percent repeatability data and an average of greater than 99.7 percent reproducibility.