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Meet the Scientist Who Built a Cheap Rapid Test in March 2020. The FDA Never Approved It

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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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This is a rush transcript. Copy may not be in its final form.

AMY GOODMAN: This is Democracy Now! I’m Amy Goodman.

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.

Dr. Bosch, it’s great to have you with us. If you can tell us, first, what happened? And I want to credit an excellent article in ProPublica that brought you to our attention.

IRENE BOSCH: Thank you. Yes, it is a very well-done article. 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.

AMY GOODMAN: I want to interrupt for a second to remind people that the U.S. government came out with a test that was faulty at the beginning.

IRENE BOSCH: It was a different test. They were faulty because they were doing PCR, which is a molecular test, not antigen test, and they made a mistake in the primers, which are a part, integral part, of this molecular test. Yes, they made a mistake, which was a huge one, but they repaired the damage. And for PCR or molecular tests, you can actually quickly in the lab iterate and fix it. But for antigen tests, FDA does not allow scientists like us to validate and approve the behavior of these tests in the lab. You have to do clinical trials, but not for PCR.

AMY GOODMAN: Right. So, explain why you were turned down and how many tests you could have gotten out there. Relate it to what we’re seeing now, this massive lack of testing available.

IRENE BOSCH: Yeah. So, generally, when you make these kinds of very simple tests — it’s just a strip — you could — a robot that makes these could make millions a week. So, the numbers, it’s a nonissue. We had really good manufacturers lined up to make these tests for us and for the United States. So that’s not a problem. So, numbers are easily made available.

Moreover, what happened to that particular case that we refer to, the E25Bio test, happened to other — also other companies. Basically, the requirements were such and perhaps maybe lack of experience — I mean, we were all new in the pandemic experience, right? FDA could have understand the way these antigen tests are meant to be used. And the reason why I say that is because for diagnostic only, like PCR, you have to be really super precise, and you have to be very, very sensitive. For antigen tests, that you use almost every day, anytime, anywhere, anyone — that’s kind of the three things that one day Anthony Fauci said that’s how we will control the pandemic — this antigen test worked beautifully, if you use them repeatedly. So, basically, that was the issue. There were no directives, or well set forth in 2020, for the use of the antigen tests. So Antigen tests can offer so much more.

AMY GOODMAN: I want to go to what the FDA recently responded to the ProPublica report about COVID-19 rapid test that you created in March 2020. In the statement, FDA said, “Unfortunately, many submissions the FDA has received for home tests include incomplete or poor data, and it is the FDA’s responsibility to protect the public health by declining to authorize poorly performing tests or those without complete data. … If the FDA received a home test that the data and science supported in early-to-mid 2020, we would have quickly authorized it.” Can you respond to this, Dr. Bosch?

IRENE BOSCH: Yeah, of course we want FDA to protect the public. I mean, as a scientist, we completely agree with that. What we don’t agree is that if you have ways to validate a test that are not the best or are way too strict, meaning you compare the PCR with like a huge expansion of the genome to a detection of a protein in your nasal cavity. So that’s the problem of the FDA. The FDA forgot to add to that quote, “Indeed, we were mistaken.” It would have been so nice to hear that.

AMY GOODMAN: So, people now know PCR tests take more time, and they are more precise. But the country is now accepting, the government is now accepting, that these antigen tests, like yours is, is critical to day-to-day functioning. So, explain when you say what’s essential is the repeated test. And explain why we are where we are today.

IRENE BOSCH: Yeah. So, this is a very important question, because 50% of people with COVID do not present symptoms, so they will not get a PCR, they will not go to a doctor, they will not go to a hospital. So they’re around just spreading the disease everywhere. So, the only mobile or deployable device is actually an antigen test, because it doesn’t need specialized apparatuses, it doesn’t need specialized technology that you need a nurse. You can do it yourself. So, by having 50% of cases being, or even more now, of cases that do not present a symptom, you ought to do it regularly in order to detect an asymptomatic case. So, regularly means, under today’s circumstances, you would have to do twice a week, minimum once a week, so that you can catch the 12 day of expansion of your viral infection. So, that’s what I mean with frequency.

We just found out — in 2020, we did another clinical trial for home use, and we found out that if you repeat antigen tests more than one day in a row, it reaches the same sensitivity as PCR. So, those things, FDA does not necessarily know, or they have not acquired that knowledge into the regulatory body, which is sad.

AMY GOODMAN: So, did other countries approve the rapid, quick COVID tests early on — I mean, countries like Britain, like Korea? And did it make a difference in their country in the spread of COVID?

IRENE BOSCH: Yeah. So, Asia and Europe did approve many, many antigen tests, 40 different brands, whereas in the United States you have barely like a handful. And so, it is true that other countries had a completely different take on how these antigen tests would work. Indeed, they understood that there is a range of virus where this antigen test will detect beautifully, day two, three, four, five, six, seven, but then it decays. So, those countries that acquired that knowledge sooner than the regulatory body of the U.S.A., they actually did better. They deployed them to the population. And they’re super unexpensive. We hear that in Germany you can buy a test for 50 cents of a dollar. So, that’s not the case for U.S.A.

AMY GOODMAN: I mean, U.S.A., the Binax test is what? Like $23, $25 for two tests. This is expensive if you’re expected to do this every single week, and let alone unavailable.

IRENE BOSCH: Absolutely. So, these tests, because we made them before, we know you can make them at 50 cents at cost. Maybe, you know, you would say, “OK, I’ll sell them for a dollar or two or three.” It’s still a decent margin for companies to return their investment. By all means, they don’t cost that much. And moreover, which is super important, these antigen tests can be now understood by a cellphone. And it becomes a super fancy gadget, because the cellphone takes a picture of the test, immediately in the cloud or immediately in real time, you know it’s a positive or negative, and you can disperse that data on the fly. So, you have something simple linked to a mobile technology to make it a really efficient monitoring tool.

AMY GOODMAN: Finally, you are now working to help other test developers carry out trials that will meet FDA regulations, even though they say they are wrong now, the FDA. Can you talk about efforts in a low-income Boston area to do the testing you feel needs to be done at this point?

IRENE BOSCH: Yeah. We found out that the at-home test, by mandate of the U.S.A. regulatory, requires a mobile phone, and many people don’t even have access to that mobile phone. And we centered our attention to the more underprivileged populations. Sometimes they only speak Spanish. Sometimes they’re elderly. So we’re now working in Chelsea, Massachusetts, to enable and educate the population on how they could use the rapid tests. All the tests we deployed in our study have been validated in Europe, in Asia and in the lab, so they’re highly performing, even some better than some of the FDA-approved ones. So, we do not deploy anything that we don’t know that it will perform well. And moreover, we teach them how to use the app, the phone app. So, yes, it’s a very interesting project. We’re looking forward to work with the community for the next four months.

AMY GOODMAN: Irene Bosch, I want to thank you for being with us, founder of the diagnostic company E25Bio, adjunct professor of medicine at Mount Sinai, visiting scientist at Massachusetts Institute of Technology, developed an inexpensive rapid test just weeks into the pandemic that the FDA turned down.

When we come back, we look at the climate change-fueled fires that have ripped through the suburbs of Denver and Boulder, the state’s most devastating wildfire in history. Stay with us.

[break]

AMY GOODMAN: “Can’t Fool Me” by the Denver-based funk band The Motet. The drummer and founder of the band, Dave Watts, lost his home and three pets in the recent wildfire.

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