Denise Esposito discussing FDA processes for drugs, devices, vaccines approval in the time of Covid19, page-2

www.theatlantic.com/health/archive/2020/08/how-to-test-every-american-for-covid-19-every-day/615217/

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The wand that will accomplish this feat is a thin paper strip, no longer than a finger. It is a coronavirus test. Mina says that the U.S. should mass-produce these inexpensive and relatively insensitive tests—unlike other methods, they require only a saliva sample—in quantities of tens of millions a day. These tests, which can deliver a result in 15 minutes or less, should then become a ubiquitous part of daily life.

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The tests Mina describes already exist: They are sitting in the office of e25 Bio, a small start-up in Cambridge, Massachusetts; half a dozen other companies are working on similar products. But implementing his vision will require changing how we think about tests. These new tests are much less sensitive than the ones we run today, which means that regulations must be relaxed before they can be sold or used.