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Diagnostics Regulatory News & FDA Approvals

The latest regulatory news and FDA approvals.

The company said it has also received Emergency Use Authorization from the US Food and Drug Administration for its nucleic acid extraction kit.

The test measures levels of interleukin 6, which is an indicator for acute inflammation and can be used to identify COVID-19 patients at high risk of intubation.

The company said its ELISA assay uses the SARS-CoV-2 nucleoprotein as an antigen for the early detection of antibodies against SARS-CoV-2.

The PCR-based tests, which detect regions in the virus' nucleocapsid gene, may only be performed at their developers' CLIA-certified labs.

The firm this week received the CE-IVD mark for its point-of-care infectious disease test and is in the middle of a US clinical study to support an FDA submission.