FDA greenlights first smartphone-based home COVID-19 test

The FDA issued its first green light for an at-home COVID-19 diagnostic that delivers results through the user’s smartphone, streamlining self-testing for students and employees as they begin to return to classrooms and the workplace.

Developed by BD in collaboration with the digital testing company Scanwell Health, the Veritor rapid antigen test operates similar to a home pregnancy test, at first. After swishing a nasal swab in a tube of liquid reagents, drops on a testing strip trigger colored lines after about 15 minutes. There the smartphone takes over, using its camera to read and interpret the results more definitively.

The agency’s emergency authorization comes just six months after the companies’ project was first announced in late February. It also arrives as demand for at-home testing begins to rise once more, with the quick-spreading delta variant driving a new surge in coronavirus cases.

The digital test, which does not need a prescription, will initially be made available to employers, schools and public health organizations looking to support routine screening programs, according to 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," Dave Hickey, BD’s president of life sciences, said in a statement.

The smartphone app automatically analyzes the test results, after walking the user through the steps. (BD)

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The diagnostic test is designed to be performed by anyone ages 14 and up and can be used for children as young as two with samples collected by an adult. Scanwell’s smartphone app, available on iOS and Android, also provides step-by-step video instructions and timers and allows users to share their results.

Before the pandemic, Scanwell used its smartphone-powered testing technology to launch home diagnostics for urinary tract infections, in partnership with the telehealth provider Lemonaid Health, for remote diagnoses and prescriptions of antibiotics.

BD, meanwhile, first received an FDA authorization for its rapid COVID-19 test in July 2020. Run on the handheld Veritor Plus system—previously used for diseases such as the flu and strep throat—the device includes the antigen test strip, which is slotted into an analyzer for a result in 15 minutes.

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Other companies have been exploring the use of smartphone cameras in delivering test results during the pandemic, including a collaboration between diagnostic maker Cellex and the machine vision developer Gauss.

Meanwhile, researchers from the University of California, San Francisco, UC Berkeley, and the Gladstone Institutes have been working on a smartphone test that uses CRISPR to produce an accurate result. 

Being developed in collaboration with Jennifer Doudna, winner of the 2020 Nobel Prize in Chemistry for co-discovering the gene editing technology, the test includes a darkened box—as specially tagged CRISPR enzymes snip the specific genes found in the coronavirus, they produce small flashes of light that can be picked up by the smartphone’s camera.