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FDA grants EUA for COVID-19 molecular tests

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The U.S. Food and Drug Administration (FDA) granted emergency use authorization to several developers of molecular tests, including Hologic’s high-throughput Aptima SARS-CoV-2 assay, according to the FDA’s website.

Separately, the FDA also granted EUA to GeneMatrix for its NeoPlex COVID 19 Detection Kit and Applied DNA Sciences for its Linea COVID-19 Assay Kit. Both test kits are designed to run on real-time PCR instruments.


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Assay kit | Coronavirus | EUA | FDA | LinearDNA | Medical Laboratory Observer