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BD Gets FDA Emergency Authorization for At-Home Smartphone-Read COVID-19 Antigen Test

NEW YORK – Becton Dickinson announced on Wednesday that it has received Emergency Use Authorization from the US Food and Drug Administration for the BD Veritor At-Home COVID-19 Test.

The digitally read rapid antigen assay is an over-the-counter test that uses an app from Scanwell Health to provide results from a nasal swab in 15 minutes.

In a statement, BD said the test is the first at-home COVID-19 rapid antigen test to use the "computer vision technology in a smartphone" to interpret and provide a digital display of results.

The app provides users with video instructions and built-in timers to perform the test, and the user then captures the test results with a smartphone camera. The app analyzes and interprets the test results, "which eliminates the human subjectivity of a visually read test," BD said.

Dave Hickey, president of BD's life sciences division, noted that the rise in COVID-19 cases from the Delta variant has increased the demand for at-home testing, adding, "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."

In addition, Hickey said the test can help businesses, governments, and schools fulfill requirements for periodic testing, particularly of people who "cannot or chose not to be vaccinated."

The BD Veritor received initial EUA in July 2020, with an OTC authorization for serial testing granted in April of this year. BD announced its collaboration with Scanwell in February.

The Franklin Lakes, New Jersey-based firm said the BD Veritor At-Home COVID-19 Test will initially be made available to businesses, schools, and governments looking to provide a self-testing option for employees or students.