ACON Laboratories has received 510(k) marketing clearance from the US Food and Drug Administration (FDA) for its Flowflex Covid-19 antigen home test.
It is claimed to be the first FDA clearance for an over-the-counter (OTC) rapid antigen test for the SARS-CoV-2 virus.
The 510(k) version of this antigen test will be manufactured at ACON’s new 97,000ft² facility in San Diego.
It is intended for use only by individuals with symptoms within the first six days following their onset. If the first test shows a negative result, it is necessary to retest within 48 to 72 hours.
ACON plans to begin distributing the test next year and will share more information with the market before the distribution starts.
In October 2021, the test obtained emergency use authorisation, allowing it to be used as a nasal swab test that can be easily conducted at home without a prescription.
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Presently, the EUA version is intended for use by both asymptomatic and symptomatic people.
If symptomatic, the individual can take the test within the first seven days of experiencing symptoms. The patient has to conduct the test a minimum of two times over a three-day period, with at least a 48-hour gap between each test.
Asymptomatic people can perform tests three times within a five-day period, leaving at least 48 hours between each test.
ACON Laboratories sales and marketing vice-president Michael Lynch said: “We are pleased to receive the first FDA 510(k) for an OTC Covid antigen test, which is symbolic of ACON’s leadership position in the market.
“This is also the first FDA 510(k) for an OTC rapid antigen test for any infectious disease. We believe this represents the FDA’s commitment to empowering people to take greater charge of their healthcare.”