San Francisco’s LaunchSquad handles Ellume, which received Food and Drug Administration emergency authorization on Dec. 15 as the first over-the-counter at-home COVID-19 test.
The Ellume COVID-19 Home Test detects active COVID-19 in individuals with or without symptoms in people aged two and up.
The Australian-based company submitted data to the FDA from an independently run clinical study that found the kit demonstrated 96 percent accuracy.
Ellum, which received a $30M grant from the National Institutes of Health, plans to ramp up production to 100K kits per-day in January.
It plans to deliver 20M kits, which will cost less than $30 each, to the US during the first half of 2021.
Sean Parsons, Ellume founder/CEO, called the company’s test kit “an important first line of defense” against the virus.