By David Bronstein
The FDA has used its emergency use authorization (EUA) process to clear five new rapid SARS-CoV-2 tests.
1. ePlex SARS-CoV-2
On March 19, the FDA cleared GenMark Diagnostics Inc.’s EUA for its ePlex SARS-CoV-2 test. The assay can be run in hospital labs instead of sending the test out to larger diagnostic laboratories, which is required for the two first two FDA cleared for COVID-19 tests by Roche and Thermo Fisher.
The ePlex system enables truly rapid testing, as in