FDA Approves American Rapid Antigen Test
What makes the FDAs failure to approve more rapid antigen tests even more galling is that the test being sold cheaply in the Amsterdam supermarket is the Flowflex, an American test made by Acon Labs in San Diego.
Well the FDA has finally approved the Acon test! Apparently it is good enough for the Germans and for US citizens. Hoorah! USA Today notes:
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.
…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 EU has authorized 21 tests beginning with the letter A (I am not sure all of these are authorized for home use but you get the idea.) Turtle slow. Still this is a big improvement.
Frankly, I think all the pressure from people like Michael Mina amplified by myself and others over 18 months and culminating in David Leonhartd’s NYTimes article Where Are the Tests? finally pushed them over the edge.