The at-home coronavirus test that recently received emergency clearance from the U.S. Food and Drug Administration may be on the shelves of drugstores as soon as February, according to the developer’s CEO.
“We’ll be shipping first product in the beginning of January. That will be ramping up through the months of January, February and March,” Ellume CEO Dr. Sean Parsons said Wednesday on CNBC’s “Squawk on the Street.”
“We would anticipate that in the second part of February or March, we would like to have that available in the major retailers across the U.S.,” added Parsons, who also founded the diagnostic products company based in Queensland, Australia.
Ellume’s product is the first at-home test for the coronavirus that does not require a prescription to receive emergency use authorization by the FDA. In November, the agency granted emergency approval to a different at-home test that required a prescription. The FDA on Wednesday also approved Abbott‘s BinaxNOW rapid coronavirus test for at-home use with a prescription.
FDA Commissioner Dr. Stephen Hahn called Ellume’s product a “major milestone” in testing for Covid-19. “By authorizing a test for over-the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test and find out their results in as little as 20 minutes,” Hahn said Tuesday in a press release.
Ellume, which received a $30 million grant for test development from the National Institutes of Health, has indicated it can have 20 million of the at-home tests produced in the first six months of 2021. However, Parsons expressed optimism about the manufacturing process. “We we’re pretty confident we can exceed that 20 million number in the first half of next year,” he told CNBC.
Parsons said everything that is needed for the test, with the exception of a smartphone to get the results, is included in the box. Ellume’s test involves a nasal swab that is less invasive than some other coronavirus tests, he said.
“And then you put that sample onto a digital analyzer,” he said. “Inside this digital analyzer is a Bluetooth-connected instrument which talks to your phone. All of the analysis happens inside of here, and the result is communicated to your phone, positive or negative.”
Ellume’s test was 96% accurate in identifying Covid-19 in people who were displaying symptoms of the disease, according to the FDA. The test was 91% accurate in identifying infections when the person was asymptomatic, the agency said.