CDC's Cardiovascular Biomarker Standardization Program Endangered

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After cooperatively funding the Lipid Standardization Program (LSP) for 50 years in partnership with the U.S. Centers for Disease Control & Prevention (CDC), the National Heart, Lung and Blood Institute (NHLBI) has unexpectedly terminated funding support for the LSP, putting the program at risk for becoming extinct at the end of federal FY 2009. The potential loss of the LSP and a planned expansion to include a broader cardiovascular disease (CVD) Biomarker Standardization Program is of great concern to the National Association of Chronic Disease Directors and its Cardiovascular Biomarker Standardization Steering Committee (CBSSC). Loss of this program will result in a significant setback to the nation's quality assurance program for laboratory testing of CVD biomarkers.

After cooperatively funding the Lipid Standardization Program (LSP) for 50 years in partnership with the U.S. Centers for Disease Control & Prevention (CDC), the National Heart, Lung and Blood Institute (NHLBI) has unexpectedly terminated funding support for the LSP, putting the program at risk for becoming extinct at the end of federal FY 2009. The potential loss of the LSP and a planned expansion to include a broader cardiovascular disease (CVD) Biomarker Standardization Program is of great concern to the National Association of Chronic Disease Directors and its Cardiovascular Biomarker Standardization Steering Committee (CBSSC). Loss of this program will result in a significant setback to the nation's quality assurance program for laboratory testing of CVD biomarkers.

LSP provides laboratories involved in cardiovascular disease-related research and clinical testing an opportunity to standardize their measurements for total cholesterol, high-density lipoprotein cholesterol (HDLC) and triglycerides. Limited funding has historically affected the development of reference standards for these tests and the timely delivery of materials necessary to maintain reference standards in laboratories. In addition, some tools needed to standardize laboratory tests properly are either not readily available or are not available at all, thus compromising the accuracy of the tests. Without reference standards, the validity and reliability of CVD laboratory tests used in both government and private-sector research and to make clinical diagnoses and establish patient treatment protocols are questionable.

Many of the laboratories that are involved in major studies of CVD funded by NHLBI participate in the LSP, including the USDA Human Nutrition Research Center on Aging at Tufts University, the University of Minnesota, University of Washington Department of Medicine, the Framingham Heart Study and Medpace Reference Laboratories. These institutions depend on the LSP to provide them with the anchor to maintain high-quality, comparable results over time within and between laboratories.

With guidance from the CBSSC, CDC is now restructuring the LSP and is investigating potential collaborative funding partnerships with laboratories and professional organizations interested in standardization. If outside support is not found, this historically important clinical and research quality assurance program will likely end on September 30, 2009.

For more information about the critical need for this quality assurance health program, contact Walter Young, PhD, Cardiovascular Biomarker Standardization Steering Committee Co-chair, National Association of Chronic Disease Directors at young @ chronicdisease.org or 303-358-4681.

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