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The United States Food and Drug Administration (FDA) announced Monday that it has issued emergency use authorization for ACON Laboratories’ Flowflex COVID-19 home test.
The OTC COVID-19 antigen test will be added to the growing list of tests that can be used at home without a prescription.
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The agency said the authorization is expected to double the capacity for rapid home tests in the coming weeks and that by the end of the year, ACON expects to produce more than 100 million tests per month and potentially 200 million tests per month by February. 2022.
“This action underscores our continued commitment to increasing the availability of OTC tests that are sufficiently accurate and reliable to meet public health needs and increase access to testing for consumers,” Jeffrey E. Shuren, director of the Center for Devices and Radiological Health from the FDA., said in a statement.
As of March 2020, the FDA has reportedly authorized more than 400 COVID-19 tests and sample collection devices.
Most home antigen tests are allowed for serial testing or for testing the same person more than once in a few days.
Based on data for asymptomatic people, ACON Laboratories’ Flowflex COVID-19 home test does not require serial testing.
These clearances, the FDA noted, follow an earlier commitment to streamline the path of COVID-19 testing tools, offering a additional model for test developers seeking emergency authorization to use certain tests for screening with serial testing and issuance an information sheet which describes considerations for selecting a test to use in a screening testing program.
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In its statement, the FDA reminded patients and users that all tests can experience false negatives and false–positive results.
The agency also stressed the importance of home diagnostic tests in the fight against the coronavirus.
“We believe home diagnostic tests play a vital role in the fight against COVID-19. We will continue to offer our support and expertise to help develop tests that are sufficiently accurate and reliable, and to facilitate increased access to tests for all Americans. “Shuren wrote.
San Diego-based ACON Laboratories Inc. said in its own accompanying statement that the nasal swab test will soon be available for purchase at major retail stores and online and will be used by people from 14 to 14 years old. years and older, or with nasal swabs collected by adults from children as young as 2 years old.
“Unlike other home tests which require testing twice in a two to three day period (a process known as serial testing), the Flowflex The COVID-19 Antigen Home Test has been approved for use as a single test by individuals with or without symptoms. This will enable the distribution of more affordable single-test packages, which will result in better access to home testing, ”said ACON Laboratories.
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President Biden highlighted rapid testing in a speech in December, promising the government would purchase 280 million tests and use the Defense Production Act to ensure manufacturers have the raw materials they need to perform. tests.
The administration is spending approximately $ 2 billion on this initiative.
The Associated Press contributed to this report.
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