FDA Authorization of Let’sGetChecked’s Home Collection COVID-19 Test
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.
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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.
