is cxs being used by the fda?

Why did the question that was put to cxs by the committee in relation to the development of specific diagnostic test come as such a surprise?

BECAUSE IT HAS NEVER BEEN ASKED BEFORE!!!

Please correct me if I am wrong, but this was never forseen as an issue because basically, there are 3 tests out there that are universally acknowledged as acceptable, yet to date no test has been FDA approved.

Therefore, when a patient shows no response to Gleevac, the doctor orders a test to determine whether his/her patient has the mutation, and if so,recommends further treatment using whatever is appropriate, which so far is only one possible drug, being Omapro. The doctor orders one of the 3 tests as mentioned above.

My theory is that the FDA have wanted an approved test for some time and now is their chance to get one. Meanwhile how many lives are lost whilst they determine a process of approval?

One can only hope that common sense prevails and this process is accelerated