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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.

The Scan

And Back

The New York Times reports that missing SARS-CoV-2 genome sequences are back in a different database.

Lacks Family Hires Attorney

A lawyer for the family of Henrietta Lacks plans to seek compensation from pharmaceutical companies that have used her cancer cells in product development, the Baltimore Sun reports.

For the Unknown

The Associated Press reports that family members are calling on the US military to use new DNA analysis techniques to identify unknown sailors and Marines who were on the USS Arizona.

PLOS Papers on Congenital Heart Disease, COVID-19 Infection Host MicroRNAs, Multiple Malformation Mutations

In PLOS this week: new genes linked to congenital heart disease, microRNAs with altered expression in COVID-19, and more.