FDA EUA Approval for FlowFlex

FDA EUA Approval for FlowFlex

The U.S Food and Drug Administration on Monday authorized a new coronavirus home test that the agency says will soon double the nation's limited supply of non-prescription tests.

The FDA's emergency use authorization of ACON Laboratories' Flowflex COVID-19 home test allows the San Diego-based company to sell its non-prescription test at retail stores as the nation's demand for quick, inexpensive tests soars.

"As a result of this authorization, we will now have tens of millions of additional tests available in the U.S. marketplace very soon," said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health told USA TODAY.

ACON expects to make 100 million tests per month by the end of this year. Production could double to 200 million monthly tests by February, according to the FDA.

ACON did not immediately say how much the company will charge or where consumers can purchase the single test. Other companies sell 15-minute home tests for as little as $23 at major retail stores.

The Biden administration is spending nearly $2 billion on coronavirus home tests to supply long-term-care facilities, community testing sites, homeless shelters, prisons, jails and other centers that serve vulnerable populations. That will be enough to buy 280 million non-laboratory tests, but some doubt it will be enough to supply K-12 schools and companies who carry out Biden's vaccinate-or-test mandate for businesses with 100 or more employees.

Biden also called for discounted home tests sold at major retailers such as Walmart, Amazon and Kroger, but those retailers’ websites and many stores have been periodically out of stock. Abbott Laboratories and Quidel Corp. cut production this spring when testing demand dropped. As the delta variant drives a surge in testing, the companies had to again increase manufacturing to supply stores.

The antigen home tests detect proteins found on the surface of the coronavirus. Laboratory-based PCR tests detect a virus's genetic material and are more sensitive than antigen tests. Lab tests are more expensive and often take one to two days to deliver results. Lab tests are more sensitive and can detect traces of the virus over a longer period, but advocates of at-home antigen tests say the kits can be deployed more quickly and cheaply and alert someone who is infectious and at risk of passing the virus to others.

The United Kingdom and Germany have made significant purchases of home tests and widely distributed them to their residents to slow the spread of coronavirus. Such large government purchases allowed manufacturers to continue making tests even when demand softened as cases dropped.

The Biden administration will spend nearly $1.2 billion to purchase up to 187 million home tests from Abbott Laboratories and Celltrion Inc., company officials confirmed. The Department of Defense announced additional contracts totaling $647 million to buy 60 million kits from Abbott and three other testing vendors: OraSure Technologies, Quidel and Intrivio Holdings.

The FDA has authorized seven antigen-based tests that can be used at home without a prescription. The agency also has authorized two molecular, PCR tests for home use.

Source: https://www.usatoday.com/story/news/health/2021/10/04/fda-acon-laboratories-covid-19-rapid-home-test/5996946001/