Ann: Presentation of BIT225-009 HIV-1 Phase 2 Data, page-925

If it's a new assay and they've used it to compare the INTRACELLULAR HIV VIRAL LOAD between the control and the BIT225 groups then it has been compared in a small clinical outcome.

The assay was designed specifically to measure how many viral particles were living in the macrophages, because current antiretroviral drugs don't touch the intracellular virus therefore it hasn't required quantification before now like we need to see when showing efficacy of bit225, it's all new stuff. 

You must have a background in politics the way you spin this stuff, Davisite.