It's been around awhile. Approval via the US FDA is what is way, way slower than almost every country, even in Europe, let alone Asia-Pacific.
That's why Asia-Pacific was using tests before we even approved them. There are lots of false-positives and false-negatives in a lot of these tests too.
E.g., the early Asia-Pacific tests were just some 'risk factors' like temperature and a 'quick inspection' of various membranes.
I.e., The US wouldn't even adopt that approach for some time, and it was never considered a 'test' here in the US, hence why the 'statistics' showed we were 'way behind.'