Join Our Newsletter - Get important industry news and analysis sent to your inbox – sign up to our e-Newsletter here
X

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

25 Mar 2021 (Last Updated March 25th, 2021 09:34)

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.