FDA Issues EUA for BD Veritor At-Home Covid-19 Test

BD, a global medical technology company, has announced that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the BD Veritor At-Home COVID-19 Test — the first at-home COVID-19 rapid antigen test to use computer vision technology in a smartphone to interpret and provide a digital display of testing results. The test does not require a prescription, a laboratory or a long wait for results.
 
BD developed this new rapid, digitally read, lateral flow antigen self-test to make COVID-19 testing faster and easier for people to complete in the privacy and safety of their own homes. The test will initially be made available to businesses, schools and governments looking to provide a self-testing option for employees or students. The BD Veritor At-Home COVID-19 Test will use a simple, pain-free nasal swab and an easy-to-use mobile app from Scanwell Health that yields reliable test results in 15 minutes. The app is available on iOS and Android and provides step-by-step instructions on how to collect and transfer the nasal swab sample to the test stick. The mobile device’s camera is then used to capture, analyze and interpret the results, which eliminates the human subjectivity of a visually read test.
 
“The  rise in COVID-19 cases from the Delta variant has increased the demand for at-home testing, and the BD Veritor At-Home COVID-19 Test is an easy-to-use test with definitive digital results that is ideal for use in the home,” said Dave Hickey, president of Life Sciences for BD. “New mandates from governments and businesses are specifying the need for periodic testing for those who cannot or chose not to be vaccinated, and this new test may help businesses, governments or schools fulfill those requirements.”
 
The BD Veritor At-Home COVID-19 Test is designed to be easily performed at home by people 14 years of age or older, using Scanwell Health’s app to provide clear digital results in 15 minutes. The test can also be used for children as young as two years old with samples collected by an adult. The simple and straightforward testing experience includes a pain-free nasal swab, video instructions that guide users through each step and built-in timers so users can self-test with confidence.  
 
“Accessible, rapid testing is an important tool for preventing outbreaks and limiting the spread of the virus,” said Stephen Chen, founder and CEO of Scanwell Health. “With the Scanwell app that provides digital, shareable results, the BD Veritor At-Home COVID-19 Test empowers individuals with the fast, actionable insights needed to help keep people safe.”