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Why Can’t We Get Testing Right?

There is a lot of media finger pointing at Biden going on right now, criticizing the administration for failing to anticipate this latest surge, some of which seems pretty fair. Even if Omicron had not come along, Delta was still raging and failing to have more rapid tests available going into the winter was a serious error. I’ll never understand why the testing situation has been so fraught in this country. They managed to roll out the vaccines pretty efficiently, why not testing?

Anyway, here’s an infuriating story about an early testing failure that will make your blood boil:

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.

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.

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, sitting in her lab at MIT. “That’s the sad story.”

A sad story, indeed. And a story that shows our sclerotic health institutions just didn’t have the necessary flexibility to respond to a fast moving crisis.

Again, I don’t understand this particular failure. Rapid tests were always going to be a useful tool in the arsenal, at least for responsible people who want to go the extra mile before interacting with vulnerable people who aren’t protected. (There doesn’t seem to be much you can do with the refusniks.) It’s always made sense to have a boatload of them at the ready for future waves.

I don’t know if they thought the tests wouldn’t work on future mutations or what, but there was a ton of money going out the door for all kinds of things that may or may not have been necessary (ventilators manufactured by Kodak anyone?) and home tests always should have been on the menu.

I bought some a while back at a fairly reasonable price but I assume that most people didn’t. It should have been easy — just pick one up at the grocery or drug store for free or just a couple of bucks. This mad rush is a mistake and one that I’m afraid the Democrats are going to pay for. This kind of thing is exactly what the public is so sick of. Oy …

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