To my knowledge, there hasn't been a clinical trial of any predictive test to show clinical benefit in a prospective randomized trial, in which patients are randomized to treatment on the basis of test results versus treatment without benefit of test results (the only exception to this is the British LRF-4 study, which showed improved one year survival for CLL patients treated on the basis of test results, compared to "physician's choice" therapy).
The LRF CLL4 trial is the first-ever prospective, randomized clinical cytometric profiling trial that involves the DISC assay. The study is focused entirely in CLL. It certainly does prove the principle of cytometric profiling in exactly the way nay-sayers have demanded. There will never be a randomized clinical trial in every cancer type and for every drug, so, at some point you have to ask yourself, given all of the other evidence that exists in support of cytometric profiling in so many other tumor types, is it reasonable to think that this clinical trial is an anomaly that applies only to CLL? Of course not!
Matutes E, Bosanquet AG, Wade R, et al, The use of individualized tumor response testing in treatment selection: second randomization results from the LRF CLL4 trial and the predictive value of the test at trial entry. Leukemia (2013) 27, 507–510; doi:10.1038/leu.2012.209
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3567236/
Bosanquet AG, Nygren P, and Weisenthal LM, Individualized tumor response testing in leukemia and lymphoma in Innovative Leukemia and Lymphoma, 2008.
http://www.crcnetbase.com/doi/abs/10...781420014082-3