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April 22, 2020

Coronavirus company news summary – FDA provides EUA for first at-home sample collection test – Applied DNA Sciences and Stony Brook University Hospital to validate Covid-19 diagnostic test

By Chloe Kent

22 April

Applied DNA Sciences has signed an agreement with Stony Brook University Hospital in New York for the validation and implementation of its nucleic acid diagnostic test for Covid-19. The test, LineaCOVID-19, can detect and quantify the presence of Covid-19 causing SARS-CoV-2 in diagnostic samples. Validation of the test will start immediately, after which the results will aid in the application to the US Food and Drug Administration (FDA) to receive the Emergency Use Authorization (EUA) before the end of this month.

South Korea-based Seegene has announced that the FDA has granted an EUA for its real-time RT-PCR test to detect Covid-19. The Allplex 2019-nCoV Assay has sold 10 million tests and is used as a standard SARS-CoV-2 assay. It can identify three different target genes, E, RdRP and N, in one reaction tube. This is claimed to offer highly accurate results and increases the amount for high volume testing.

The FDA has reissued its EUA for the first Covid-19 diagnostic test that has a home collection option. The approval was granted to LabCorp, to test samples collected by patients with its Pixel by LabCorp COVID-19 Test home collection kit. Patients can self-swab their nose and mail the sample using the insulated package to a LabCorp lab.

ChromaCode has launched its HDPCR SARS-CoV-2 real-time PCR Assay that can detect the virus using nasopharyngeal swab from a patient suspected to have Covid-19. The test has been validated by ChromaCode and is pending an independent review of the validation data by the FDA.

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