SAN DIEGO — The U.S. Food and Drug Administration this week took action to increase peoples' access to rapid, at-home COVID-19 tests by issuing an emergency use authorization for a product made by a San Diego-based company.
Flowflex by ACON Laboratories is an over-the-counter, antigen test. The FDA says its authorization will increase consumers' access to rapid testing. The test becomes the latest on a list of those that can be used without a prescription.
Most antigen tests are used for serial testing - testing the same individual more than once within a few days - however, the FDA's announcement indicated the Flowflex does not require serial testing based on data of asymptomatic patients.
According to the Associated Press, more than 18 months into the pandemic, the U.S. trails other nations in supplies of at-home tests but is on pace to have about 200 million of them available per month beginning in December
At-home tests are widely used overseas as part of regular testing programs to catch asymptomatic infections. While less accurate than PCR tests, at-home kits are cheaper and faster, allowing for serial screening of children, long-term care residents and office workers.
The FDA hopes the EUA for Flowflex will help the U.S. catch up and "is expected to double rapid at-home testing capacity in the U.S. over the next several weeks." By the end of 2021, ACON plans to produce more than 100 million tests per month and double that to 200 million per month by February 2022.
ACON Laboratories was founded in 1996 in Pennsylvania and moved its headquarters to San Diego in 1999. Its current headquarters is located in Sorrento Valley while its manufacturing is done in China. Their website includes information on several COVID-19 testing products including the Flowflex.
Flowflex is now one of more than 400 COVID-19 tests and sample collection devices that have been authorized by the FDA since March 2020.
