If you've tried to purchase an over-the-counter (OTC) COVID-19 test in recent months, you've likely had to go to numerous retailers to find one in stock. The newly approved at-home testing kits for COVID have flown off the shelves faster than companies can manufacture and restock them, leading to the federal government's unprecedented effort to mail free tests to every American household.1
The public's rapid acceptance of home COVID tests is one signal of the market's possible readiness for more at-home testing kits covering a wider variety of conditions. Although such kits are available for many conditions, they are not yet widely embraced — but diagnostic testing companies are working to capitalize on this moment. The rise of home COVID tests may one day come to mark the beginning of the shift toward individual, at home diagnostics for widespread health conditions.
The evolution of at-home testing kits
The first home pregnancy tests arrived on the market in 1977, signaling the beginning of OTC diagnostic tests. These tests use a technique known as lateral flow immunoassay, which analyzes and measures substances like antibodies, antigens and hormones. The technique can work with various liquid samples, such as urine, blood, saliva and mucus.2
Though home pregnancy tests measure the hormones in urine, home COVID tests measure the antigens in nasal mucus. These and other types of home testing kits use lateral flow devices (LFDs), which can come in different forms, such as a dipstick or a cassette housed in packaging. Because they're easy to use, patients can use them at-home to quickly and economically obtain initial test results.
As LFD technology has evolved, there are now at-home testing kits available to identify markers for a number of conditions including sexually transmitted diseases, colon cancer, HIV, tuberculosis, malaria and others; some tests provide immediate results while others must be mailed in for results. There are also OTC tests that measure or monitor blood glucose, blood pressure and cholesterol.2
Pandemic boosts demand for OTC tests
Though the at-home diagnostic testing market has quietly grown for decades, the pandemic rapidly expanded the demand for such tests. COVID test shortages and high rates of transmission from person to person combined to make home-based testing an ideal solution.
"Consumers like the convenience and privacy of at-home tests," says Diane Bernstine, director of business development and lab innovation at McKesson Medical-Surgical. Many OTC tests can provide results within 10 or 15 minutes and confirm whether a doctor visit is necessary.
As the public increasingly aims to get "back to normal" despite new COVID variants continuing to surge, OTC tests provide a "cost-effective way to provide a rapid diagnosis," Bernstine says. In addition, at-home testing is available to meet many of the government's requirements for traveling, which is helpful as the demand for travel increases, Bernstine says.
Finally, the market for home COVID tests continues to grow, as the federal government committed to the purchase of one billion at-home rapid tests to send to Americans for free upon request. And with many state and local authorities establishing rules for schools, workplaces and retail establishments, employers, schools and individuals want tests "in order to move about safely," Bernstine says.
Pandemic will lead to more at-home testing
For many medical testing companies that have developed reliable OTC tests for COVID, the pandemic has been the experience that put them on the map. With the success of home testing kits for COVID, many of these companies plan to pivot into developing and manufacturing additional types of diagnostic tests.
For example, Abbott, which makes the BinaxNOW™ rapid antigen COVID-19 test as well as lab-based PCR tests and rapid molecular tests, is currently producing more than 100 million tests per month, CEO Robert Ford said at the most recent J.P. Morgan Annual Healthcare Conference. But even when there isn't as much COVID test demand, the company's work to develop that capacity will remain important. That's because Abbott is using this experience to lay a foundation for a larger diagnostics portfolio.3
Though some of Abbott's tests focus on COVID, "There will be a tailwind of upper respiratory infectious disease testing," Ford says. "Then there's an opportunity for us to develop new tests and add to those [test] boxes, and that's strategically what the team has been working on."3
Other test companies are working on similar plans. Cue Health, for example, has found great success with its molecular COVID-19 test, but it has plans to add other tests including flu, respiratory syncytial virus (RSV), chlamydia and gonorrhea.3
Speaking at the same event, the CEO of Quidel Corporation, Doug Bryant, said that they were focusing on moving further into the consumer market, beyond COVID testing.
"We have to demonstrate that individuals can collect [specimens] properly and that will be very helpful in clinical trials where we try to demonstrate the sensitivity and specificity necessary to meet the FDA's hurdles for OTC products," the CEO said. "That's very much on the forefront of our minds and is something we're working on."4
Some newly developed at-home tests offer smartphone apps, which allow users to access test results within a matter of minutes.5
What to expect for home health tests
As consumers have become increasingly comfortable using diagnostic testing at-home during the pandemic, demand is likely to grow for more types of OTC diagnostic tests.
"Moving forward, products that are readily available, affordable and easy for consumers to use with respect to handling, reading and following instructions and interpreting results, will earn market share," Bernstine says.
At-home health tests aren't likely to replace the more accurate and sensitive tests performed in doctors' offices and labs. However, they will increasingly become a vehicle for quickly delivering early diagnostic information, which will lead to a more rapid patient response. "These tests actually may help labs by eliminating work involved with negative results and allowing more time to focus on positive cases," Bernstine says.
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Be advised that information contained herein is intended to serve as a useful reference for informational purposes only and is not complete clinical information. This information is intended for use only by competent healthcare professionals exercising judgment in providing care. McKesson cannot be held responsible for the continued currency of or for any errors or omissions in the information.
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