Yeah, it stinks, and it's rarely the right approach. In this case they wanted to avoid a complex re-validation, but it was short sighted. The assay was not mark

Yeah, it stinks, and it's rarely the right approach. In this case they wanted to avoid a complex re-validation, but it was short sighted. The assay was not market ready yet anyway, we had no difficult to obtain clearances, and the original design was lacking in many ways. It was essentially image analysis techniques take straught out of the 70's. The new system is much better.