As the U.S. faces a shortage of rapid COVID tests amidst the Omicron surge, we turn now to speak to a scientist who developed an inexpensive rapid at-home COVID test nearly two years ago, but the FDA refused to approve it. Irene Bosch is the founder of the diagnostic company E25Bio. She’s a visiting professor at MIT, adjunct professor of medicine at Mount Sinai, New York. In March 2020, she submitted the test to the FDA for emergency authorization. The FDA approval never came. It would be another year before more expensive at-home COVID tests began appearing on the market. Today those tests are hard to come by, if not impossible, as the U.S. grapples with 400,000 new COVID infections a day. Irene Bosch joins us now from Cambridge, Massachusetts.
And what happened was that in 2020, we had — a group of scientists had already made, for about 10 years, other very similar antigen tests for other viral diseases, so we jumped into COVID basically knowing a bit of what we were doing. So, by April, we had already made a test. By July, we completed our first clinical trial in the United States. And indeed, it was the first submission to the FDA. It was this one.
But then, short after we presented the data, we learned that it was going to be really hard to meet the standards. We, of course, agree with having excellent tests being approved. At that time, we thought the standards were ill-defined, and they were too harsh for meeting their requirements. Other than that, the test was excellent, and it could have been approved under 2021 standards.
— source democracynow.org | Jan 03, 2022