This Scientist Created a Rapid Test Just Weeks Into the Pandemic. Here’s Why You Still Can’t Get It.

Irene Bosch developed a quick, inexpensive COVID-19 test in early 2020. The Harvard-trained scientist already had a factory set up. But she was stymied by an FDA process experts say made no sense.

When COVID-19 started sweeping across America in the spring of 2020, Irene Bosch knew she was in a unique position to help.

The Harvard-trained scientist had just developed quick, inexpensive tests for several tropical diseases, and her method could be adapted for the novel coronavirus. So Bosch and the company she had co-founded two years earlier seemed well-suited to address an enormous testing shortage.

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, along with a consortium of investors led by 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. (Disclosure: Khosla’s daughter Anu Khosla is on ProPublica’s board.)

On March 21 — when the U.S. had recorded only a few hundred COVID-19 deaths — Bosch submitted the test for emergency authorization, a process the Food and Drug Administration 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.

COVID-19 (SARS-CoV-2) Neutralizing Antibody Test

In the months that followed, Bosch responded to repeated requests from FDA reviewers for data and studies. When the agency finally put out guidance that summer about the performance 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.