FDA EUA approval very soon......28 May 2020 19:56
I fully anticipate FDA EUA approval for the GDR PCR test to be obtained very soon since most, if not all, validation documentation used to obtain the CE Mark approval can be re-used. It could be tomorrow but more likely next week. Then the USA market is wide open - simpler PCR test, accurate, consistent, reliable and quicker than other PCR tests being used. These particular features of the GDR PCR test make it an attractive proposition for the millions of tests the USA need.