FDA authorizes another COVID-19 at-home test


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ACON Laboratories Antigen Test Does Not Require Serial Testing

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The US Food and Drug Administration (FDA) announced on Monday that it has issued an emergency use authorization for the ACON Laboratories Flowflex COVID-19 Home Test.

The over-the-counter (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 authority expects to double at-home testing capacity over the next several weeks and that by the end of the year, ACON expects to conduct more than 100 million tests per month and potentially 200 million tests per month by February . 2022.

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The director of the FDA’s Center for Devices and Radiological Health, Jeffrey E. “This action highlights our continued commitment to increasing the availability of appropriately accurate and reliable OTC tests to meet public health needs and to increase access to testing for consumers,” Shuren said., said in a statement.

Since March 2020, the FDA has reportedly authorized more than 400 COVID-19 testing and sample collection devices.

Most antigen tests for home use are authorized for serial testing or testing of the same person more than once within a few days.

Based on data from asymptomatic individuals, the ACON Laboratories Flowflex COVID-19 Home Test does not require serial testing.

These authorizations, the FDA noted, come on the heels of a past commitment To streamline the path to COVID-19 screening tools, a . to provide supplemental template For test developers seeking emergency use authorization of certain tests for serial testing and screening with issuance a fact sheet which outlines considerations for selecting a test for use in a screening test program.

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In its release, the FDA reminds patients and users that all tests can lead to false-negatives and false experiences.positive results.

The agency also stressed the importance of home diagnostic testing in the fight against the coronavirus.

“We believe that at-home diagnostic tests play an important role in the fight against COVID-19. We will continue to offer support and expertise to help develop appropriately accurate and reliable tests, and all Will facilitate increased access to tests for Americans,” Shuren wrote.

San Diego-based Akon Laboratories Inc. said in its own statement that the nasal swab test will soon be available for purchase in major retail stores and online and will be used by individuals 14 years of age and older, or by adults. The collected will be done with a nasal swab. Children under 2 years old.

“Unlike other home tests, which require testing twice within a two- to three-day period (a process known as serial screening), FlowFlex The COVID-19 Antigen Home Test is authorized to be used as a single test by persons with or without symptoms. This will allow for the delivery of more affordable single-test packaging, resulting in greater access to home testing.” Akon Laboratories said.

President Biden highlighted the rapid tests in a speech in December, pledging that the government would buy 280 million tests and use the Defense Production Act to ensure manufacturers have the raw materials needed to perform the tests.

Administration is spending approx. $2 billion on the initiative.

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