The United States faces a shortage of rapid COVID-19 tests amid the Omicron surge even as many inexpensive at-home rapid testing models have been ready for distribution — but refused approval by the U.S. Food and Drug Administration. One scientist, Harvard-trained Irene Bosch, submitted a rapid test to the FDA for emergency approval in March 2020 and even had a factory ready to produce it. Bosch describes how the FDA’s rejection came from unclear standards set by the administration early on in the pandemic, and says earlier approval of testing like hers could have saved lives.

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