At-home COVID-19 testing will soon be everywhere

After weeks of shortages across the country, Americans are gradually finding it easier to get rapid antigen tests at home. That’s largely because the Biden administration’s massive buying frenzy gives test companies the confidence to manufacture and distribute a product that, like the course of the pandemic itself, has an uncertain future.

Executives at several major testing companies say that as their production lines expand, they are prioritizing orders from the federal government to fulfill those lucrative contracts. Because of that strategy, some other buyers, including retailers and state governments, still find it challenging to get enough testing to meet current demand. But supply constraints are expected to ease as manufacturers use their big payday to boost production.
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“Some manufacturers were very apprehensive about expanding production because they didn’t know there would be a demand for these tests,” said Lindsey Dawson, a KFF (Kaiser Family Foundation) researcher who has tracked U.S. rapid-test stocks. “These manufacturers are reassured of a buyer – the federal government.”

Indeed, companies must invest in employees and facilities to meet the high demand. But if the demand is temporary, that investment could backfire. Consider what happened in the spring of 2021: At the time, health authorities emphasized home testing as a public health strategy and focused instead on vaccinations, which had proven to be incredibly effective at preventing people from getting sick. Demand for tests plummeted and Abbott Laboratories, which makes the popular BinaxNOW self-test, couldn’t even unload its inventory — so had to simply throw away test components nearing their expiration date.

Demand is now incredibly high, to the point where manufacturers can’t keep up. Federal contracts urge them to comply with the moment. iHealth, which received a $1.3 billion federal contract to supply 250 million tests, had scaled its production to 10 million tests per day at the end of January, up from 1 million in November. Still, it can’t fulfill all the order requests it gets from retailers, states, nonprofits, and employers.

The company aims to double production by the end of February, but in the meantime, the federal distribution programs that serve all Americans may relieve some of the pressure at the state and local levels. “We need to limit our supply to several states a little bit,” said Chief Operating Officer Jack Feng. But, he adds, “If the federal government will give everyone free tests, it will help those states too, [which] not have to buy so many tests.”

Now in its third pandemic year, the US relies on frequent testing to limit the spread of the virus. As the highly contagious strain of Omicron swept across the country, many health authorities revised COVID-19 guidelines, curtailed contact tracing efforts — which had become unruly and ineffective — and shortened recommended quarantine periods. “Test-at-home” and “test-to-stay” programs became the standard strategy to avoid business and school closures, address labor shortages and return to life safely and with regularity.

Read more: What you need to know about COVID-19 testing, from PCR to antigen to antibody

Rapid at-home antigen tests, which provide results within minutes, can help curb the viral spread if individuals take a Pap smear before meeting with others — then stay home if they’re positive. Of course, this is only possible if people have tests at hand. As cases mounted in the final weeks of 2021, Americans went into a shopping spree so they could test before traveling, gather for the holidays, and then go back to work. To bolster national supplies, the Biden administration announced in late December that it would allocate $4 billion to a program where it would purchase 500 million home tests, then distribute them for free through an online ordering system, with a limit of four per day. households. In January, the government promised to double the number to 1 billion tests. So far, it has distributed tests to 60 million households, or about half of the US households

Manufacturers were only allowed to participate in the federal program if they previously had unassigned tests, available for shipment within two weeks, so as not to divert existing testing supplies they had promised to states or retailers. But according to interviews with business executives and reviews of recent revenue calls, the companies that received federal contracts have since prioritized federal obligations over other new order requests. Siemens Healthineers, for example, received emergency use approval from the US Food and Drug Administration (FDA) in late December and quickly became a government supplier, contracting to deliver 50 million tests by the end of February. Production for other outlets is still scaling up — about 12 million tests will be available this month through retailers, including Amazon, a company spokesperson told TIME. In an earnings call last week, Siemens CEO Bernd Montag said, “We don’t have the channels, nor the ambition yet, to go too much into a dispersed retail space. So, of course, number one is the big government programs.”

†[Manufacturers] have a whole range of contracts they bid on,” said David Dreyfus, an assistant professor of supply chain management at Rutgers University Business School who specializes in healthcare operations. “If they win these contracts, they’ll have to scramble a little bit and say, oh boy, we’ve got a big one here. What are we going to do? And who will be pushed away until later?”

Many households will quickly use their free federal test and then have to rely on other outlets such as health centers and retailers to get more, so it’s critical that those places have a reliable inventory. States are eager to hand out free tests to make it easier for residents to comply with “test-to-stay” programs, but their offerings are limited. For example, Washington state launched a website on January 21 where residents can order up to five free tests. All 1.4 million were claimed within eight hours. Orders resumed 10 days later – and supplies were wiped out the next day.

Read more: It’s time to end compulsory masks in schools

Ohio ordered 1.2 million tests in early January, but did not receive the first shipment of 400,000 tests until mid-month. The state had to suspend supplies to public libraries and local health departments to prioritize schools and universities. Deliveries came in faster at the end of the month — the state was able to distribute about 875,000 tests in January — but there isn’t enough to get by. “We expect our ability to provide testing to these local partners will remain somewhat intermittent,” said Ken Gordon, a spokesperson for the health department. “We have started receiving additional testing, but not at the volume we initially planned, and not at a consistent cadence.”

Some retailers and state officials have blamed the federal government for gobbling up the supply when their supplies run out. Maryland Governor Larry Hogan clashed with the Biden administration when, the week the federal program kicked off, state suppliers cut orders to aid national distribution efforts. A spokesperson for the Maryland Department of Health declined to tell TIME which manufacturers had pulled the plug, but said White House officials have addressed and resolved the issue.

“It’s up to manufacturers, to private industry, to make these decisions about what the United States needs for future public health measures,” said KFF’s Dawson. “They are not necessarily public health experts and they have a fiduciary responsibility to their shareholders.”

In the future, however, companies investing in manufacturing operations will be poised to serve a variety of buyers — be it U.S. states, the federal government, nonprofits, private employers, or other countries that may need massive quantities. . That is good for public health and for business, experts say.

“From a manufacturing standpoint, it’s never a good idea to spend 100% of your capacity on one product or one customer,” said Nada Sanders, a professor of supply chain management at Northeastern University. “It’s very risky. One of the tenants of supply chain management is to diversify.”

Read more: Omicron could be the beginning of the end of the COVID-19 pandemic

Some executives are skeptical about sustaining demand even as they scale their operations. “I would very much expect that … specifically on antigen testing, probably as we go into the summer they will drop sharply,” Roche Diagnostics CEO Bill Anderson said during an earnings call last week, but warned that “it is very difficult.” to predict how things will turn out.” Roche, which produces both lab and home antigen tests that detect the COVID-19 virus, received FDA authorization for its at-home kits on Dec. 24 and won a $380 million contract from the federal government in mid-January. company declined to share the number of tests in the contract.) The first delivery of tests delivered to the federal government is now reaching Americans who ordered them through the federal website. The company plans to partner with retailers, pharmacies and states.”Disaster-up takes time after authorization,” noted Matt Sause, president and chief executive of Roche Diagnostics North America, in an email to TIME. “It’s a brand new product manufactured in South Korea and it will take several weeks to produce.” The company plans to conduct tens of millions of tests for Americans each month.

Public health policies and personal risk tolerance — not to mention the virus itself — are constantly changing. Whether demand remains consistently high for the long term, or the ebb and flow of virus cases, manufacturers are better prepared to handle the market in the future.

The US has been catching up with testing since the start of the pandemic. In its earliest days, long before home tests were available, the country struggled with cotton swabs and reagent shortages, severely limiting the number of lab tests it could conduct. Then, in the summer of 2020, people waited weeks for results due to lab backlogs. The country was again flat-footed during last year’s Delta swing because so few testing companies had received FDA clearance.

The federal government needed the Omicron testing crisis to boost the free market. While some states and retailers are still dealing with supply issues, the supply chain will no doubt become smoother — and may finally be ready for what comes next.

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