Everlywell, a digital health company, and Ginkgo Bioworks, a life sciences company, have entered into an agreement to distribute Access Bio’s CareStart™ Covid-19 antigen test, which has been approved by the US Food and Drug Administration (FDA), to government offices, workplaces, schools, clinics and health plans. The CareStart™ Covid-19 antigen test includes a disposable rapid antigen testing lateral flow device that can detect the SARS-CoV-2 infection just 15 minutes.
The FDA is monitoring the potential impact of Covid-19 viral mutations, including an emerging variant from the United Kingdom known as the B.1.1.7 variant, on authorised SARS-CoV-2 molecular tests. It believes the risk that Covid-19 mutations will impact overall testing accuracy is low. The agency has reminded clinical laboratory staff and health care providers about the risk of false negative results with all laboratory tests, including molecular tests. Laboratories should expect some false results to occur even when very accurate tests are used.
Matt Hancock, the Health and Social Care Secretary of the UK, has announced that the government has ordered for two million of the first British-manufactured rapid lateral flow antigen tests for use in asymptomatic testing, which will be validated by Public Health England. SureScreen Diagnostics, a bespoke diagnostic solutions manufacturer, will provide the two million lateral flow tests, which yields results in less than 30 minutes.