The coronavirus test at home that recently received emergency authorization from the U.S. Food and Drug Administration may be on pharmacy shelves as early as February, according to the developer’s CEO.
“We will ship the first product in early January. This will increase during the months of January, February and March,” Illume CEO Dr. Sean Parsons, on CNBC’s “Squawk on the Street.”
“We would anticipate that in the second half of February or March we would like to have it available to major US retailers,” added Parsons, who also founded the diagnostic products company based in Queensland, Australia.
The Ellume product is the first non-prescription coronavirus home test to receive FDA emergency use authorization. In November, the agency granted emergency approval to a different home test that required a prescription. The FDA on Wednesday also approved Abbott’s BinaxNOW coronavirus rapid test for home use with a prescription.
FDA Commissioner Dr. Stephen Hahn, described the Elume product as an “important milestone” in the Covid-19 tests. “By authorizing a test for over-the-counter use, the FDA allows it to be sold in places like pharmacies, where a patient can buy it, whip their nose, do the test, and find out the results in as little as 20 minutes. Hahn said in a press release on Tuesday.
Ellume, who received a $ 30 million grant for testing development from the National Institutes of Health, has indicated that he may have 20 million home tests produced during the first six months of 2021. However, Parsons expressed optimism about the manufacturing process. “We are confident that we will be able to exceed that number by 20 million during the first half of next year,” he told CNBC.
Parsons said the box includes everything needed for the test, except for a smartphone to get the results. The Ellume test consists of a less invasive nasal swab than other coronavirus tests, he said.
“And then place that sample on a digital analyzer,” he said. “Inside this digital analyzer is a Bluetooth-connected instrument that speaks to your phone. All scans are done here and the result is communicated to your phone, positive or negative.”
The Ellume test was 96% accurate in identifying Covid-19 in people who had symptoms of the disease, according to the FDA. The test was 91% accurate in identifying infections when the person was asymptomatic, the agency said.