I am not sure that is correct. While with the recently obtained CLIA Waiver they could theoretically provide certain specific, waived diagnostic tests in to a primary healthcare setting in the US, it is my understanding that they will not do so. They have obtained the the CLIA Waiver in order to be able to support clients, that are on an FDA approval pathway and require support with their translational research, product development and clinical trials programs. The CLIA Waiver and subsequent audit will allow them to provide service that are deemed FDA compliant.
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