The home coronavirus test, recently approved as an emergency by the U.S. Food and Drug Administration, could be on drug store shelves as early as February, according to the developer's CEO.
"We will ship the first product in early January. That will increase in the months of January, February and March," said Ellume CEO Dr. Sean Parsons on CNBC's "Squawk on the Street" on Wednesday.
"We expect to have this available at major US retailers in the second half of February or March," added Parsons, who also founded the Queensland, Australia-based diagnostic products company.
Ellume's product is the first at-home test for the coronavirus that does not require a prescription to be approved for emergency use by the FDA. In November, the agency issued an emergency permit for another home test that required a prescription. The FDA also approved Abbott's BinaxNOW rapid coronavirus test for home use with a prescription on Wednesday.
FDA Commissioner Dr. Stephen Hahn described Ellume's product as an "important milestone" in testing for Covid-19. "By approving an over-the-counter test, the FDA enables it to be sold in places like drug stores, where a patient can buy it, wipe their nose, do the test, and find out the results in just 20 minutes," Hahn said Tuesday in a press release.
Ellume, who has received a $ 30 million grant from the National Institutes of Health for test development, has stated that 20 million tests can be performed at home in the first six months of 2021. However, Parsons was optimistic about the manufacturing process. "We are pretty confident that we can exceed that 20 million number in the first half of next year," he told CNBC.
Parsons said that everything needed for the test, except 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 on a digital analyzer," he said. "Inside this digital analyzer there is a bluetooth-connected instrument that communicates with your phone. All the analysis takes place here and the result is transmitted positively or negatively to your phone."
Ellume's test was 96% accurate to identify Covid-19 in people who showed symptoms of the disease, according to the FDA. The test was 91% accurate in identifying infection if the person was asymptomatic, the agency said.