Harvard-Trained Savant Created A Rapid Test For COVID In Early 2020 But FDA Sat On It

The Harvard-trained scientist Irene Bosch had just developed quick, inexpensive tests for several tropical diseases when the COVID-19 pandemic struck and her method could be adapted for the novel coronavirus.

Photo Insert: Irene Bosch (left) Co-founder & CTO and Bobby Brooke Herrera, PhD (right) Co-founder and CEO

So, Bosch and the company she had co-founded two years earlier seemed well-suited to address an enormous testing shortage, Lydia DePillis reported for ProPublica.

E25Bio — named after the massive red brick building at MIT that houses the lab where Bosch worked — already had support from the National Institutes of Health (NIH), along with a consortium of investors led by the Massachusetts Institute of Technology (MIT).

Within a few weeks, Bosch and her colleagues had a test that would detect coronavirus in 15 minutes and produce a red line on a little chemical strip. The factory where they were planning to make tests for dengue fever could quickly retool to produce at least 100,000 COVID-19 tests per week, she said, priced at less than $10 apiece, or cheaper at a higher scale.

Bosch’s prototype attracted a top Silicon Valley venture capital firm, which pitched in $2 million. “We are excited about what E25Bio is capable of shipping in a short amount of time: a test that is significantly cheaper, more affordable, and available at home,” said firm founder Vinod Khosla.

On March 21 — when the US had recorded only a few hundred COVID-19 deaths — Bosch submitted the test for emergency authorization, a process the Food and Drug Administration (FDA) uses to expedite tests and treatments.

A green light from the FDA could have made a big difference for the many Americans who were then frantically trying to find doctors to swab their noses, with results, if they were lucky, coming back only days later. But the go-ahead never came. Bosch responded to repeated requests from FDA reviewers for data and studies.

When the agency finally put out guidance that summer about the performance of over-the-counter home tests needed to meet, officials required that such tests be nearly as sensitive as the lab tests used to definitively determine whether a patient has COVID-19.

That standard proved difficult to meet. Rapid tests are usually sensitive enough to detect viral antigens when someone has enough of them to be able to spread the disease.

Such tests are not as good at picking up cases in either earlier or later stages of infection when viral loads are lower. Bosch’s tests missed the FDA’s high bar. It wasn’t until the spring of 2021 that much larger companies were able to design similar tests — relatively inexpensive, over-the-counter rapid tests — that the agency found acceptable.

“You could have antigen tests saving lives since the beginning of the pandemic,” said Bosch, originally from Venezuela, sitting in her lab at MIT. “That’s the sad story.”

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