BD Receives Emergency Use Authorization for First At-Home COVID-19 Test to Use Smartphone to Interpret, Deliver Results

• BD Veritor™ At-Home COVID-19 Test is Over-the-Counter, Rapid Antigen Test Using Scanwell Health Mobile App to Deliver Reliable Results in 15 Minutes
• Digitally Read Test Provides Clear Positive or Negative Confirmation of COVID-19 Status

BD announced the U.S. FDA has issued an Emergency Use Authorization 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.

FRANKLIN LAKES, N.J., Aug. 25, 2021 /PRNewswire/ — BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, announced today 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.”

For more information on the BD Veritor™ At-Home COVID-19 Test, please visit bdveritor.com.

About the BD Veritor™ At-Home COVID-19 Test
The BD Veritor™ At-Home COVID-19 Test has not been FDA cleared or approved; but has been authorized by FDA under EUA. This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of IVDs for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

About BD
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its 70,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians’ care delivery process, enable laboratory scientists to accurately detect disease and advance researchers’ capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. For more information on BD, please visit bd.com or connect with us on LinkedIn at www.linkedin.com/company/bd1/ and Twitter @BDandCo.

About Scanwell Health
Scanwell Health empowers health care consumers and companies through at-home medical testing with instant results. Scanwell pairs proven diagnostics with patented computer vision technology to put testing into the hands of people, enabling quick detection of acute illnesses and convenient monitoring of chronic diseases. The company is the first and only to receive FDA 510(k) clearance for an over-the-counter diagnostic smartphone application. Learn more at scanwellhealth.com.

SOURCE BD (Becton, Dickinson and Company) https://www.prnewswire.com/news-releases/bd-receives-emergency-use-authorization-for-first-at-home-covid-19-test-to-use-smartphone-to-interpret-deliver-results-301363030.html