Sean Parsons, CEO of Ellume, the Queensland, Australia-based company that developed the test, which was authorized Dec. 15 by the FDA, told CNBC that it plans to ship the first tests in January. The company said it expects it can produce 20 million tests in the first half of 2021 and even more the second half.
FDA commissioner Stephen Hahn, MD, said the test, called the Ellume COVID-19 Home Test, is a “major milestone” in COVID-19 testing, CNBC reported. Ellume received a $30 million grant from the National Institutes of Health to develop it, and it was found to be 96 percent accurate in identifying symptomatic cases of COVID-19 and 91 percent accurate for asymptomatic cases.
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