Figure 8. To demonstrate utility of the assay, and generate internal data on the range and variability of PCSK9 a study was conducted in the target population; patients receiving the standard of care statin treatment for hypercholesterolemia. Three groups of subjects were included; Group 1 normal subjects receiving no statin treatment; Group 2 subjects receiving atorvastatin (Lipitor^®) treatment at 40mg/Day; Group 3 subjects receiving atorvastatin at 80 mg/Day. As shown the concentrations of PCSK9 were elevated in groups receiving atorvastatin treatment as compared with normal subjects. The values obtained for PCSK9 in this study across the groups were consistent with the range cited within the literature of 100–1000 ng/mL.⁸