[gdpawel]

This is starting to sound very much like the situation with Herceptin years ago. Herceptin drew fire from the FDA and other groups, including ASCO, because of its expense and the fact that it helped only 11-20% of patients who received it.

There were tons of data showing that pathologists were "over-calling" the cases of HER2-positive via IHC and manual microscopy. There were tons of data showing that use of automated image analysis virtually eliminated "over-calls" and very reliably normalized IHC scoring among pathologists of all levels of experience.

Even Dennis Slamon (one of the inventors of Herceptin) had told Genentech, they had a drug that is even better than they knew. It only has to be administered to the right patients. The disinterest on the part of Genentech was palpable.

In the end, the FDA did force them to work with someone to develop a reliable pharmacodiagnostic test. Genentech put their muscle behind FISH.

However, in the end, they couldn't completely supplant low-tech IHC and both received FDA approval. Herceptin is now approved for patients who are positive via FISH or IHC, even though patients considered Her2-negative using both tests benefited from Herceptin.

In other words, the problem was never solved. It's an inconvenient truth which everyone involved conveniently chooses to ignore. Sheesh!