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July 31, 2020

Coronavirus company news summary – FDA expands EUA awarded to Seegene – Qualigen commences sale of Covid-19 test

By Chloe Kent

Precipio has entered into an agreement with ADS Biotec for the distribution of its FDA-authorised Covid-19 serology antibody tests. The products will be distributed in the US and other markets around the world. Initially, Precipio plans to roll out the antibody tests as CLIA test run in its laboratory following which it will be distributed as POC (point-of-care) test after further authorisation from the FDA. Finally, it will distribute it for at-home, direct-to-consumer use.

Seegene has announced that the US Food and Drug Administration (FDA) has expanded the Emergency Use Authorisation (EUA) for the Allplex 2019-nCoV Assay, an RT-PCR test for Covid-19 coronavirus. The expansion of the EUA will increase the number of nucleic acid extraction/isolation systems, extraction kits and PCR instruments avaliable.

BD has announced an investment of $24m from the US Department of Defence in partnership with the US Department of Health and Human Services. The investment is expected to aid the increase in the manufacturing capabilities in the US for the BD Veritor Solution for Rapid Detection of SARS-CoV-2 virus.

Qualigen Therapeutics has commenced commercial shipments of the FastPack SARS-CoV-2 IgG diagnostic test for Covid-19 coronavirus antibodies. The company has submitted the test to the US Food and Drug Administration (FDA) for EUA. Earlier this month, Qualigen provided an official notification to inform the FDA regarding its plans to exercise its right to start sales amid the pending EUA.

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