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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.
Charlie Chapman, a policy advisor to Health & Human Services Secretary Robert Kennedy Jr., has joined BGR’s health & life sciences practice.
The future of DTC should foster understanding and trust, as well as improving clinical conversations.
Healing the Sick Care System: Why People Matter, a new book from FINN Partners chair global health and purpose Gil Bashe, says that the current healthcare system is not broken because it lacks innovation, talent or investment, but because it has lost sight of the people it exists to serve.
