Valid regarding what? That it does in fact detects AD in the brain and we didn't buy a lemon? Or was this validation more about the technique used in conducting the blood test? How can they assess proper technique without checking resulted accuracy? Without a specificity and sensitivity figure, can we really feel at ease that we didn't "buy a lemon"? I honestly do not understand.
I can't yet assess whether we've puchased a lemon, I'm still reveling in my 'small displacement engine' metaphor!
I think you can reasonablly infer that that clinical patient sample that produced the specificity and sensitivity % we're familiar with would...reproduce those same results.
If the process is valid, the only variable left is patient selection.
JN's take: "Becton, Dickinson & Co is an expert in flow cytometry. In fact, BD Biosciences may be the best in the world in this area. That's why Amarantus engaging with BD for LymPro sample analysis and analytical performance was so important. Amarantus now has one of the world's bests in flow cytometry looking at the issues that causes unacceptably high intra-sample variability during Provista's Phase II study. The news today (LINK) from Amarantus announcing that BD has validated the previous findings from the Phase I study and established Analytical Performance (reliability and reproducibility) of the test is an enormous leap forward."
Maybe one of our physician posters can add more clarity?