The FDA approved something this week that could be just as valuable as vaccines in halting COVID-19
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The idea that more Americans might die in a single day from COVID-19 than died on 9/11 has amazingly become passé. In just a week, that milestone was reached, reached again, then left thoroughly in the dust. Then on Wednesday, previous records were blown away. Whether you take the value from WorldOMeters (3,538) or CNN (3,700), the number of Americans who died unnecessarily from a disease that was purposely allowed to rage across the nation has never been worse … though it almost certainly will be. The United States now has over 17 million COVID-19 cases, just under a quarter of all the cases in the world.
But against that background of absolute, well-nigh ultimate darkness, there was also some good news on Wednesday. That includes a second vaccine that is likely to be approved this week, the “vaccine Hanukah miracle” where nurses have discovered that each vial of Pfizer vaccine actually contains enough to provide at least one extra dose, and FDA approval of three home tests that may be the most important step in genuinely controlling the disease.
Almost from the outset of the pandemic, there has been a huge disparity in testing. At first, tests were so unavailable, or in such short supply, that a massive spike was underway in the Northeast before officials even realized what was happening. Even after tests became more widely available, they’ve largely been the domain of state officials who could encourage their use, or make it all but impossible. In just the last week, five states tested at least 1% of their total population for COVID-19. That includes New York, which has been testing at a high rate since it became possible. At the other end of the spectrum, Iowa tested about 0.1% of its population. The 35% positive rate in Iowa is a perfect indicator of just how inadequate testing there remains. Despite a month in which cases have fallen across much of the Midwest, some of this “improvement” may be purely illusory thanks to situations like Iowa, where testing has declined.
Over the last 10 months, a number of tests have come onto the market. But despite promises of cheap, fast tests that could be performed at home, testing has been limited, administered by medically trained personnel, and remained largely unavailable. For people stuck in their homes, afraid to visit with friends or family, repeated news that White House staff, NBA players, or actors involved in a television series are “getting tested every day” generate more anger than relief.
The idea of fast, saliva-based COVID-19 tests where people could get home pregnancy test-style results in a matter of minutes at a cost of around $5 have been a matter of frequent press releases and the subject of several studies. But these have remained unavailable. For the moment, they still are.
What the FDA has approved is a non-prescription test from Australian firm Ellume. This test still involves a nasal swab, which means that, yes, using it does require shoving a stick up your nose. However, the end of that stick doesn’t have to penetrate as brain-scrapingly deeply as most formal tests. Other such nasal tests have been available, often from companies that have been willing to provide the medical cover needed to conduct the test. However, those tests have required sending back the swabs for results that arrive in days. The Ellume test can be used in coordination with an app available on Android or iPhones to deliver results in about 20 minutes. Ellume is reported to be announcing a marketing deal that would make the test available at major retailers, like CVS or Walgreens. However, it is not actually likely to available on nearby shelves in time for anyone’s Christmas dinner. The retail price is expected to be around $30.
The listed accuracy of the test is 100% for genuinely negative samples. That is, if you don’t have COVID-19, you don’t need to worry about a false positive. However, the test was 96% accurate on positive sample (91% accurate on asymptomatic cases), leaving the possibility that it could still miss out on those who have the disease—something to consider before you decide to employ the test to clear relatives before your holiday gathering. But the test was more accurate in identifying those in the first week of infection, the time when people are most contagious. So if you’re planning a get-together, think about first getting people past the term “mid-turbinate swab.” The test correctly identified 100% of negative samples and 96% of positive samples from people with symptoms when compared to lab-based tests, according to Ellume. In people without symptoms, it identified 91% of positive samples and 96% of negative samples.
A second test from Lucira has also been approved, but for the moment that test still requires a prescription to obtain. The Lucira test is attractive for its easy-to-read “all in one” design, but in addition to being more restricted in access, it’s expected to be priced around $50. Lucira is making their test available in clinical settings over the next few weeks and expects to make millions of tests available shortly after the start of 2021.
Finally, the FDA has also approved Abbott’s BinoxNow test. This test is essentially identical to one that has been used in hospitals and nursing homes for months, so its use and accuracy is well-tested. Like the Ellume test, it also coordinates with a smartphone app, but in the BinoxNow case, users download the app first, fill out a questionnaire, and use it to order the test. The test is then shipped by mail, so those wanting a genuinely fast response will need to think ahead. Abbott plans to make 30 million tests in the first quarter of 2021 with a price of $25. However, at this point the Abbott test also requires a prescription.
The soon-to-be-announced availability from major retailers, the lack of need for a prescription, and the fact that people can obtain the test without first filling out a questionnaire will likely make Ellume’s test the most used over the next few months. However, those same qualities also make it the test least likely to be covered by insurance, so calculate that cost before snapping up a stockpile.
The fact that none of these tests are available to pick up today is still frustrating, but the FDA approval signals that they will be available in the very near future. So while they may not help in guaranteeing access to your grandmother’s special holiday coconut cake, they might help make it possible to hold a properly constrained and socially distanced family get-together a few weeks from now. (No matter what your test results, this is not permission to invite a few hundred of your closest over for a mask-free snog-a-thon.)
Behind all these, that fast saliva-based test is still on the way. The test, designed by Stanford bioengineering professor Manu Prakash, can produce results in 10 minutes, and has accuracy that is supposedly similar to the swab-based tests. Prakash has hoped to produce the test for as little as $1—which would make it extremely practical for millions of people to test on a regular basis. But so far it doesn’t appear that there is any agreement with a major company to manufacture these tests, or any sign of seeking FDA approval. As good as the idea may be, it is unlikely to reach a shelf near you any time soon.
However, the swab-based tests now becoming available, while not perfect and too expensive for repeated use by most people, do mean that millions who think they might have COVID-19 can be tested quickly and safely at home. They can then take appropriate actions to isolate themselves. Which makes these tests incredibly valuable. Oh, and that smartphone app that the Ellume test uses? It doesn’t just get your age to make sure the test is approved for your use, it also reports test results to local authorities. This is done so that at-home testing figures can be worked into regional and state planning.
Had these tests been available a few months ago, they might have generated a powerful impact on the surge now sweeping across the nation. But just because vaccines are now becoming available doesn’t mean that it’s too late for these tests to be valuable.