Low Density Lipoprotein Subclass Separation
Lipoprotein subclass distribution technology has been under development at the Lawrence Berkeley National Laboratory for over 50 years. Multiple scientific and medical publications have demonstrated the importance of these measurements in clarifying coronary heart disease risk and substantiating clinically important differences in response to treatment interventions including, weight loss, exercise, diet, alpha blockers, beta blockers, bile acid binding resins, fibrates, nicotinic acid, and statins.1-8 In 1997, the World Congress of Clinical Pharmacology (IUPHAR)9 presented proposed guidelines for phase III and IV drug testing that included recommendations that gradient gel electrophoresis (GGE), as measured by the proprietary segmented GGE (S-GGE) methodology developed by Berkeley HeartLab, Inc. and the Lawrence Berkeley National Laboratory, be included in the approval process for all new lipid-lowering medications. It is important to appreciate that not all GGE systems or lipid fractionation technologies provide equivalent information. The analysis resulting from the more definitive Berkeley HeartLab system is based on multiple clinical trials using this refined method and multiple clinical trials that originally used both GGE and Analytical Ultracentrifugation (AnUC) for lipoprotein characterization. S-GGE provides the highest degree of validation, quality, accuracy, and assessment for the analysis of lipoprotein heterogeneity. S-GGE has a direct correlation to AnUC lipoprotein characterization, considered the “gold standard” reference technology, through published investigations and analyses that are not available with any other commercial laboratory system.
Source: http://www.bhlinc.com/cirm.php?chapter=5
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