Thats interesting Dr D from many perspectives. If as you say...

Thats interesting Dr D from many perspectives. If as you say that the FDA approval is contingent on supplementary data and the time constraints have passed then the Japanese test would appear to have addressed many of those concerns. Other tests run in the US, that we are not privy of, were to address the balance of issues not covered by the Japanese tests.

What is ironic is that the CDC, who issued the 'conditional' guidelines from the original FDA approval, have also played a pro-active role in running these additional tests and producing the results to address those same outstanding issues.

There are also other tests coming to light, comparisons of the Quantiferon test with the Clinispot process, which all seem to point at the one conclusion.

As I said , interesting.