Coronavirus company news summary - ProterixBio completes licensing of Covid-19 serology test - Gravity Diagnostics receives FDA update for EUA - Verdict Medical Devices
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Coronavirus company news summary – ProterixBio completes licensing of Covid-19 serology test – Gravity Diagnostics receives FDA update for EUA

02 Jul 2020 (Last Updated July 2nd, 2020 09:22)

ProterixBio has finalised a licensing agreement for a Covid-19 antibody test with the Massachusetts General Hospital. Researchers at Ragon Institute developed and validated the assay. The assay is an enzyme-linked immunosorbent assay (ELISA) which measures antibodies that attach to the Receptor Binding Domain (RBD) of the spike protein of SARS-CoV-2.

Sherlock Biosciences has partnered with binx health to develop a rapid, point-of-care diagnostic test for Covid-19 that uses CRISPR technology. The organisations will combine the binx io diagnostic platform with Sherlock’s CRISPR technology. This is expected to make the test robust and easy to use. It is designed to offer rapid and accurate results in a single patient visit in different settings.

Qualigen Therapeutics has submitted a notification to the Food and Drug Administration (FDA) to start the sale of its FastPack SARS-CoV-2 IgG test for Covid-19 antibodies in the US. The company has submitted the test for Emergency Use Authorization (EUA) from the FDA. With this notification, the company can sell the test even before the EUA is granted.

The FDA has expanded the EUA for Gravity Diagnostics‘ Kroger Health COVID-19 Test Home Collection Kit, which can now be used to collect nasal swab specimens that are self-collected by individuals at home. This is an addition to the previous EUA that was received on 1 June 2020.