"As long as these tests are regulated as medical devices, the FDA has to regulate them not as critical public health tools, but as medical tools, with all of the onerous clinical trials that slow everything down 100-fold,"With only a handful of rapid tests on the market, it is harder for companies that haven't yet gotten FDA authorization to catch up and, in turn, drive the prices down, said Michael Greeley, a co-founder and general partner at Flare Capital Partners, a venture...
Broad adoption of rapid testing seems premature, he said, even with a mass purchase of tests by the U.S. government: "We can't even get people to floss, so the idea that people are now going to start rapid testing as their standard operating procedure is a flawed assumption."Ellume said use of its tests spiked by 900 percent over the past month. Its at-home rapid test costs up to $38.99.
from the Defense Department in February to scale up production after the FDA authorized its at-home use late last year. But the federal Health Care Enhancement Act, which furnished the funding, doesn't restrict pricing. Ellume said it will begin production at a plant in Frederick, Maryland, this fall. For now, it is shipping tests from Australia.
This summer, Lucira Health stopped selling its roughly $50 molecular rapid test online to focus on larger clients, including the Olympics and San Francisco's Chase Center, home to the Golden State Warriors, Dan George, Lucira's chief financial officer,
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