Dive Brief:
- BD has received FDA emergency use authorization for an at-home COVID-19 rapid antigen test that uses smartphones to deliver and interpret results.
- The test, which BD says is the first of its kind, is the result of the collaboration the company formed with Scanwell Health early this year. Users download the Scanwell app, follow instructions given via video and receive a positive, negative or invalid result on their smartphone screen.
- BD is launching the Veritor At-Home COVID-19 Test against a backdrop of rising demand for similar diagnostics, with the Wall Street Journal reporting availability of kits from Abbott and Quidel has been spotty.
Dive Insight:
The introduction of the test could help BD revitalize its COVID-19 testing business. Veritor sales hit $688 million in the first quarter but came in below $300 million over the next two reporting periods, falling to a low of $212 million in the third quarter.
Other medtechs, including Abbott, Quidel and Qiagen, also reported a sagging demand for testing in the first half of the year before the latest variant took hold.
The delta wave in the U.S. has driven increased demand for at-home testing, leading companies including Abbott and Ellume to ramp up production to address shortages.
The U.S. COVID-19 rapid antigen test market has become increasingly congested since BD became the second company to enter the space in the summer of 2020. New entrants to the market brought improved sensitivity and lowered costs, notably by providing all-in-one disposable tests, but BD still sees an opportunity to differentiate.
"Our test is designed to deliver a clear, digitally displayed record of test results on a smartphone to eliminate the reading guess work, and we also designed it to allow the data to be digitally shared by the user to eliminate errors and report sharing," BD CEO Tom Polen told investors on a conference call earlier this year.
BD gained access to the mobile technology through its collaboration with Scanwell, a provider of smartphone-enabled at-home medical tests. The Scanwell app guides the user through the swabbing process. Then, by aiming the smartphone camera at the kit, the app delivers the test result.
Using a smartphone to interpret and deliver the results eliminates the need for the instrument that is essential to the existing Veritor test. Freeing users from the need to purchase a dedicated instrument removes a barrier to the use of the product and puts BD in more direct competition with products such as Abbott's all-in-one BinaxNOW COVID-19 Ag Card.
BD's test performed nearly identically to the healthcare professional version of the Veritor kit. In a study of 648 subjects, 10 people generated invalid results. Among the remaining subjects, the positive percent agreement was 84.6% and the negative percent agreement was 99.8%.
