According to the developer’s CEO, the coronavirus test at home, which recently received an emergency permit from the U.S. Food and Drug Administration, will hit drugstore shelves as early as February.
“We will ship the first product in early January. That will increase over January, February and March,” said Ellume CEO Dr. Sean Parsons Wednesday on CNBC’s “Squawk on the Street”.
“We expect that we would like to have that available from major retailers in the US in the second half of February or March,” added Parsons, who also founded the diagnostic products company in Queensland, Australia.
Ellume’s product is the first home test for the coronavirus that does not require a prescription to receive emergency use approval from the FDA. In November, the agency issued urgent approval for another home test that required a prescription. The FDA also approved Abbott’s BinaxNOW rapid coronavirus test for prescription home use on Wednesday.
FDA Commissioner Dr. Stephen Hahn called Ellume’s product an “important milestone” in testing for Covid-19. By approving a test for over-the-counter use, the FDA allows it to be sold in places like drugstores, where a patient can buy it, wipe their nose, perform the test, and find their results in just 20 minutes Hahn said in a press release on Tuesday.
Ellume, which received a $ 30 million grant for test development from the National Institutes of Health, has indicated that it will be able to produce 20 million of the home tests in the first six months of 2021. However, Parsons was optimistic about the manufacturing process. “We’re pretty sure we can exceed that number of 20 million in the first half of next year,” he told CNBC.
Parsons said everything needed for the test, with the exception of a smartphone to get the results, is in the box. Ellume’s test includes a nasal swab that is less invasive than some other coronavirus tests, he said.
“And then you put that sample on a digital analyzer,” he said. “Inside this digital analyzer is a Bluetooth-connected instrument that talks to your phone. All analysis takes place in here and the result is sent to your phone, positive or negative.”
Ellume’s test was 96% accurate in identifying Covid-19 in people who showed symptoms of the disease, according to the FDA. The test was 91% accurate at identifying infections when the person was asymptomatic, the agency said.