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March 25, 2021

Coronavirus company news summary – US FDA authorises LetsGetChecked’s home collection Covid-19 test – Xlear submits Covid-19 pre-emergency use authorisation to FDA for nasal spray

By Chloe Kent

LetsGetChecked has announced that the US Food and Drug Administration (FDA) has authorised the use of its home collection Covid-19 test, which is now available without a prescription. The test will be available for those who do not suffer Covid-19 symptoms or suspected exposure to the virus.

Aurora Biomed has announced that the company will start distributing the FaStep Covid-19 antigen rapid test device in the Canada this week. The 15-minute test is based on a lateral-flow immunochromatographic assay, and detects antigens specific to SARS-CoV-2 in nasopharyngeal samples of infected or exposed individuals.

Xlear, a xylitol-based products manufacturer, has filed for a pre-emergency use authorisation (Pre-EUA) approval with the US FDA for the use of its nasal spray in preventing SARS-CoV-2 transmission and infection. Earlier, the company had sought approval for nasal spray as a medical device to fight Covid-19. However, the FDA determined that it worked against the virus, and should therefore be considered as a drug or combination product EUA.

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