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Here's the lowdown on COVID-19 tests right now

COVID-19 is back and so is testing. (Double ugh.)

The COVID surge has us scrambling plans for holiday parties, travel to grandma’s house and return to office. It’s also creating a mad rush for COVID tests.

Welcome (back) to our onerous new reality, with vaccine mandates, masks requirements and testing protocols. And with testing comes the oh-so familiar questions: When were you tested? Where? Which kind of test?

I was thinking about the sheer volume of human, never mind economic activity associated with COVID testing and decided to delve into this for my column, focusing mostly on rapid tests, because that’s where much of the action is right now.

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Testing has certainly become part of my life. Not quite like brushing my teeth, but like grocery shopping, which is to say once a week or so. Since Nov. 1 for instance I’ve been tested nine times, (most recently yesterday) and I anticipate a similar cadence going forward. I’m seeing family members and co-workers getting tested in increasing numbers and frequency as well. (Your experience may vary of course.)

A few months ago it looked like the need to test was winding down, but the variants and especially Omicron reversed that trend. Not only did we the people think testing was going away, (remember the days of scheduling PCR tests at a doctor’s office?), but so did at least one test maker, more on that below.

Before we get into the current situation with tests, let’s do a quick 101. As you may know (and forgive me if this is elementary, Watson), generally speaking there are two types of COVID tests at this point; the first being molecular tests, the most common being PCR (reverse transcription polymerase chain reaction, if you will) tests that usually require a lab. (Yes, there are also some molecular tests using for instance CRISPR technology, as well as “isothermal nucleic acid amplification, digital polymerase chain reaction, microarray analysis, and next-generation sequencing.” Got that?)

The second type of tests are antigen or rapid tests, which can be done on site (school, office, party, etc.) or even at home, which as I said I will focus on.

PCR tests detect the presence of the virus itself and are more accurate, but more expensive and take more time to produce results. Antigen tests, according to the CDC "detect the presence of a specific viral antigen, which implies current viral infection" and as "rapid tests" suggest, take only 15 minutes of waiting time, with the whole process requiring less than a half hour. Rapid tests are also cheap but less accurate.

Next, some unassailable facts. The U.S. has not exactly led the world in testing protocols or the rollout of tests. Our government made a decision to support vaccine efforts (and not so much tests) and sent billions of dollars to Moderna, Pfizer and Johnson & Johnson either to develop the vaccine or to buy vaccines or both — which I wrote about two weeks ago: Guess who pays for all those millions of COVID-19 vaccines. No major efforts were made with tests really, until early October, when the Biden administration said it would buy $1 billion of rapid tests.

At a White House briefing in October, Jeff Zients, the White House coronavirus response coordinator, said that by the end of the year, the U.S. will have a “run rate” of “about a half billion tests per month, about half of which will be ... the popular at-home test” as well as the PCR tests that people can take at a pharmacy, clinic or doctor’s office.

End of the year would be right about now. And yes, tests are out there. Sort of. Amazon was sold out when I looked yesterday. But Walmart.com was not. Many drug stores in NYC where I live didn’t have any. As for PCR tests, some street kiosks offering tests now have long lines.

A COVID-19 testing site in New York City. Credit: Andy Serwer
A COVID-19 testing site in New York City. Credit: Andy Serwer

Testing shortages are not the norm in other developed countries though. In England, testing has become part of daily routine for many of its citizens. And tests are free and easy to get, according to CBS News.

“Getting the test kits couldn't be easier," the London correspondent notes. "They're readily available at pretty much every pharmacy in the country. Anyone can just walk in and ask for them — and they're completely free, usually distributed in boxes of five or seven. You can go back and get as many as you need.”

Meanwhile, the White House has been getting testy over its coronavirus testing regimen. NPR’s Mara Liasson recently pressed White House Press Secretary Jen Psaki on rapid tests by asking “why not just make them free and have them available everywhere?” Psaki responded — seemingly sarcastically — by asking: “Should we just send one to every American?”

The exchange went viral and prompted this come-backer from Erica Wilkinson of Slate: “It is true that mailing a single test to every American would be kind of silly, and expensive (that’s why they should be sending many tests — as for the cost, we’re in a pandemic!)”

Looks like we will in fact be needing many more tests. The Washington Post reported yesterday afternoon: “Students who have been exposed to the coronavirus can safely continue in-person learning if they are regularly tested for the virus at school, avoiding disruptive at-home quarantines, the Centers for Disease Control and Prevention said Friday.”

How did we get behind the eight-ball with tests? “What we needed was a project warp speed for testing,” says Neil J. Sehgal, an assistant professor of health policy and management at the University of Maryland School of Public Health. “That didn't happen under the previous administration, whose stance was that more tests weren't necessarily better and in fact, more testing led to more cases."

He added: "Whether it was through bad advice or an abundance of optimism, both the former and current administrations really banked on vaccines putting an end to the pandemic. That drove this delay on large scale federally-backed purchases of COVID-19 tests.”

Sehgal says the FDA has also played a role here. “[The] slow regulatory approval process has ... What's the right way to put this? It's reduced the availability,” he says. “It's created some of the supply constraints that we are seeing in the availability of rapid tests. More than 30 antigen tests have been developed in the U.S., but very few of those have FDA authorization for over the counter use. This is one of the reasons that we see less availability in the U.S., compared to the EU. That's because the FDA has taken a stricter stance than its European counterparts. More recently, in some of the comments from folks in the administration, they had held up that the FDA is very thoroughly vetting tests before they come to market.”

Dr. Michael Mina certainly has some thoughts on this subject. Mina, chief science officer of eMed, (more on eMed in a minute) and ​​former assistant professor of epidemiology & immunology and infectious diseases at Harvard’s T.H. Chan School of Public Health, has been an outspoken advocate for full deployment of rapid tests, and even for prioritizing them over PCR tests.

With rapid tests "individuals can take ownership over their small slice of public health,” Mina says. “And that's really the only way we can battle a pandemic like this, is when we bring the public into the process. And we have done a horrible job at doing that."

“The FDA currently does not formally recognize that there is such a thing as a test for public health,” Mina continues. “We have such a biomedical centric approach to everything. We have institutions and policies that cannot get out of their own way to understand that a test doesn't have to be a medical diagnostic test."

Mina added: "Public health agencies actually helped block the roll out of these powerful public health tools because they saw it through one lens, which is ‘Our job is to track the epidemic.' And they didn't really have a lens of saying 'our job is to just ensure everyone has the tools to not transmit to their family.’”

OK so now, what is eMed? It is a digital testing platform, founded and led by Dr. Patrice Harris, which has partnered with Abbott, maker of the BinaxNOW rapid test, and offering online supervision and verification of the test. This fills a need because home tests have been potentially problematic because a) people sometimes didn’t do them right and b) they aren’t accepted in some cases because you can’t really prove that the test you upload is yours. With eMed, a technician walks you through the process, watches you take the test and waits for the results and verifies it.

I just tried using eMed this past week — and it worked — and will use it again when coming back from Europe where I’m traveling tomorrow (gulp). When I return to the U.S., I’m flying on United Airlines, which is requiring either a PCR or rapid lab test, or an eMed certified test.

But now we’ve gotten ahead of ourselves. What about eMed’s partner, Abbott and its Abbott BinaxNOW test? How big of a deal is it? Does it work? Answer: The test is in fact a pretty big deal and it seems to work well. When the pandemic hit early last year, Abbott, like so many health care companies, plunged full bore into new types of work. CEO Robert Ford pulled company scientists off other projects and directed them to four testing projects. The effort paid off. According to the company:

“Abbott launched the BinaxNOW professional test nationwide in August 2020 and scaled up production at its new U.S. manufacturing facilities to produce 50 million tests per month. The U.S. Department of Health and Human Services (HHS) purchased the company's first 150 million tests, sending them to K-12 schools, nursing homes, historically black colleges and universities, and underserved communities, where they remain in use today and serve as a powerful tool to help prevent the virus from spreading.”

The Abbott Lab’s BinaxNOW COVID-19 home test. Credit: Andy Serwer
Abbott Lab’s BinaxNOW COVID-19 home test. Credit: Andy Serwer

Abbott didn’t receive FDA approval for retail distribution though, until this March and first rolled out the tests at Walgreens, Walmart and CVS on April 19. The BinaxNOW test has quickly become a big business. In Abbott’s third quarter, released in late October, the company reported “​​COVID-19 testing-related sales of $1.9 billion, of which approximately $1.6 billion were rapid tests.” This out of total sales of $10.9 billion. Retail cost of these tests, as you may know, goes for $23 for a box of two tests. So that’s a lot of sold tests.

Unlike vaccines, which are 100% free, testing is more complicated. Walk-up kiosks here in New York are giving free PCR tests, (paid for by Uncle Sam, perhaps, since I have been able to procure them when I didn’t have my insurance card.) After that, well, I’ll turn things over to our ace medical reporter, Anjalee Khemlani who says:

1. Many experts want insurers to cover the costs of testing but it’s an incredibly imperfect system. Many tests are generally not covered (for example testing for work or for travel). You are likely on your own for that.

2. It will soon be possible to get reimbursed for some at-home tests but it’s a real pain as everyone knows and many experts acknowledge it’s a bad system.

3. Going in person to same day facilities is one of the few ways you can get it directly covered for free. But even that’s imperfect: Anjalee saw an urgent care clinic and a pharmacy next door to each other. The urgent care would test for free but the pharmacy was charging $50, which was in theory reimbursable.

For now, you can buy a rapid test and then try your luck getting reimbursed from your insurer or depending on your use case, maybe even by your employer. Still at least we have access to tests now, unlike last year when only PCR tests were available, along with the occasional outrageous bill.

“We've long believed in the trend to decentralize some of the testing," Abbott CEO Ford told Khemlani in a November interview. “It's not an ‘either or.’ It's an ‘and,'” Ford said. “A lot of testing historically has been done in hospitals and labs. And what we see now with COVID is this trend to be able to add on a different type of testing, one that's a little bit more decentralized.”

Ford talked about Abbott’s app, (which I’ve also used). “Not only did we develop the Binax test, but we also developed a companion app called Navica that connects the test with your phone so that you can have your green pass to say, hey, I tested, and I've been tested negative. So I think that's an important aspect of it.”

It hasn’t been smooth sailing for Abbott, though. This past summer, the company laid off hundreds of workers and closed a facility which manufactured tests. Revenue projections swung too. In January the company forecast $6.5 billion to $7 billion in annual COVID test revenue. By last summer the forecast was down to $4 billion to $4.5 billion. Abbott’s stock (ABT) has slightly outpaced the overall market year-to-date (up 26% versus 23% year) and since the beginning of the pandemic (from March 2, 2020 to yesterday up 70% versus 56%.) In other words, COVID testing has been a good business for Abbott so far, but it hasn’t been a game changer like the vaccine for Moderna.

BTW, I don’t begrudge Abbott for making money here. It’s a risky, expensive business that with any luck will go away at some point. Abbott and the others are helping us fight COVID, saving untold numbers of lives as well as who knows how much money by preventing the spread.

And there is an urgency here, according to Ed Yong of The Atlantic, in this recent piece. Tests work detecting Omicron, but it’s tricky.

“Omicron may also be especially difficult to catch before it spreads to others, because its incubation period— the window between infection and symptoms — seems to be very short. At an Oslo Christmas party, almost three-quarters of attendees were infected even though all reported a negative test result one to three days before.”

What we really need is something rare in modern America, a sense of common purpose. As Yong notes: “Like the variants that preceded it, Omicron requires individuals to think and act for the collective good —which is to say, it poses a heightened version of the same challenge that the U.S. has failed for two straight years, in bipartisan fashion.”

Testing saves lives, but rather than get with the program, too many of us channel our inner 6-year-old, as in: “You can’t make me do that.”

Wish I could tell them to go sit in a corner. In the meantime, expect more testing of ourselves and our society.

This article was featured in a Saturday edition of the Morning Brief on December 18, 2021. Get the Morning Brief sent directly to your inbox every Monday to Friday by 6:30 a.m. ET. Subscribe

Correction: A previous version of this story misidentified Abbott Labs CEO Robert Ford as Richard. It has been corrected. The story also corrected its definition of how Antigen tests work. They detect the presence of a specific viral antigen, not antibodies. A photo caption has also been updated to clarify that the BinaxNOW COVID-19 home test is manufactured by Abbott Labs, not eMed.

Andy Serwer is editor-in-chief of Yahoo Finance. Follow him on Twitter: @serwer

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