On Monday, October 4th, 2021 the Food and Drug Administration (FDA) in the United States issued emergency use authorization (EAU) for one type of at-home COVID testing. The specific home test is made by ACON Laboratories and is called “Flowflex Covid-19 Home Test. It brings us one step closer to reliable over-the-counter (OTC) tests that address this public health need.
At-home antigen tests are nothing new, but for COVID-specific testing, this supplier and test is brand new. Soon, adults will be able to purchase this OTC test without the need for a prescription. The FDA expects this authorization to double the capacity for at-home rapid testing over the course of just several weeks, and ACON Laboratories anticipates production at 100-200 million tests per month by February of 2022.
With the need for at-home testing growing every day, this ramping up of ACON Laboratories’ test production makes sense. Whether someone wants to test before they travel or attend a large event, or just to ensure their own safety and health after a possible COVID exposure, this new means of testing in the convenience of one’s home is sure to help millions of Americans. Access to testing has been one of the known constraints since COVID began in early 2020, and with tests like the Flowflex COVID-19 Home Test under this new EAU, we can further bridge that testing gap.
“This action highlights our continued commitment to increasing the availability of appropriately accurate and reliable OTC tests to meet public health needs and increase access to testing for consumers,” Jeffrey E. Shuren, director of FDA’s Center for Devices and Radiological Health, said in a statement.
This at-home COVID test is not the first to be authorized by the FDA since March 2020, but what is notable is that it does not require serial testing, like many of its at-home predecessors. Serial testing, or testing the same person more than once within just a few days, is not necessary for ACON Laboratories’ test. This means even greater access and testing capacity, as it does not rely on a prior test to inform the current test. It also does not require that the individual receiving the test exhibits any symptoms.
Please be advised that the FDA reminds all patients that any test can provide false-negative and false-positive results. It is important to follow up with your healthcare provider and if you want to test twice, to give yourself more assurance, you can do that, too.
While lab testing is more sensitive than at-home tests, advocates for these at-home antigen tests point to the speed at which the test kits can be deployed. The quickness, coupled with their less expensive price tag, helps alert someone who may be infectious so that they can slow the spread and prevent passing the virus, unknowingly, to others.
The nasal swab test will soon be available for purchase online and with major retailers, according to ACON Laboratories, based in San Diego, California. The test can be performed on someone as young as 2 years old, and the company notes that people 14 years and older can perform the test on themselves.
The price of these specific tests has yet to be announced, but similar tests that take 15-minutes to deliver results at home sell for as low as $23. The pricing for tests in the United States is much more expensive than we see across the globe. In Germany, rapid tests are available for less than $1 at grocery stores, and in the United Kingdom, every person has access to 14 different free rapid tests. The average price in the United States is about $15. This gap in testing prices was pointed out by Senator Tim Kaine of Virginia.
Shuren, with the FDA, shared “Investing in production and availability will drive more tests in the marketplace. I think you’ve seen for other countries that have more tests coming on, those are the steps they’ve taken. This is a case of economics. If you shore up the marketplace with guaranteed purchasing, large numbers, you can also bring down prices and you can increase availability.”
Recently, the Biden administration announced that it is spending close to $2 billion on coronavirus home tests. These tests will supply homeless shelters, prisons, jails, long-term-care facilities, community testing sites, and other places that serve more vulnerable populations. About 280 million tests are covered under that $2 billion, leaving some to wonder, will it be enough? With Biden’s introduction of the vaccine-or-test mandate for businesses with over 100 employees, and the additional supply needed for K-12 schools, only time will tell.
Another piece of Biden’s order is that discounted home tests are sold at retailers like Amazon, Kroger, and Walmart, but keeping inventory in stock has proven difficult. Some suppliers, like Quidel Corp and Abbott Laboratories, cut their production in the Spring of 2021 when the demand for testing dropped. With the delta variant now driving a testing surge, these companies increased their production to adequately supply stores. The addition of ACON Laboratories’ Flowflex Covid-19 Home Test, with this recent EAU approval from the FDA, will help the supply grow exponentially. At this time, the FDA has authorized seven tests that are antigen-based that can be used without a prescription, at home. There are also two molecular, PCR tests, authorized by the agency for home use.
The FDA expects that with the EAU of ACON Laboratories Flowflex COVID-19 Home Test, our nation’s supply of non-prescription tests will double by Q1 of 2022. “We believe at-home diagnostic tests play a critical role in the fight against COVID-19. We will continue to offer support and expertise to help with the development of appropriately accurate and reliable tests, and to facilitate increased access to tests for all Americans,” Shuren shared.