my understanding is that Cepheid has 23,000 testing machines. 5,000 of them are in US. The new test cartridge will work on existing machines. [1] FDA approval

my understanding is that Cepheid has 23,000 testing machines. 5,000 of them are in US. The new test cartridge will work on existing machines. [1] FDA approval is for the specific test, not for the machine itself (as those did not need to change). I was searching for analogous situation, where these machines were able to accurately detect other infections and it seems that they were able to perform at 100% for flu-A at 100% accuracy. [2] My impression sofar, is that FDA was definitely asked to work faster and more efficient, but it does not seem like that they had 'cut corners' so to speak, and approved something out of the 'blue'. [1]https://www.lucianne.com/2020/03/21/rapid_coronavirus_test_approvedbrby_fda_results_in_45_minutes_30086.html https://www.lucianne.com/2020/03/21/rapid_coronavirus_test_a... [2]https://www.labmedica.com/microbiology/articles/294780980/point-of-care-molecular-tests-compared-for-pediatric-influenza.html https://www.labmedica.com/microbiology/articles/294780980/po...