t315i mutation testing , page-11

Further explanations here about the test and the FDA's response. It also lists the two types of tests that are currently on the market.

http://www.pharmastrategyblog.com/2010/03/chemgenix-will-need-a-validated-t315i-mutation-test-for-omacetaxine-in-cml.html

"This isn't really surprising: if you are claiming to target a particular marker or target, then you need a validated companion diagnostic test to be commercially available once the drug is approved. I think what the FDA is saying to ChemGenex is that they need to do a small study comparing and validating the data between commercial assays and the ones used more commonly in hospital Path labs for research purposes and clinical trials. It's not a big deal, but it does need to be done."