BlueCross BlueShield of Tennessee Medical Policy Manual

Multi-Analyte Assay with Algorithmic Analyses for Predicting Risk of Type II Diabetes


Type II diabetes mellitus is a highly prevalent disorder that is associated with an extremely high degree of morbidity and mortality. The incidence has been increasing rapidly over the last several decades, and current trends indicate that this increase will continue. Efforts to thwart this trend are aimed at early identification of those individuals at risk for developing this disease and development of preventive interventions targeted at the high risk population.

Many different risk prediction instruments have been developed that combine clinical, laboratory, and family history. There is evidence that different models have different accuracy depending on the population tested and relatively simple models have performed similarly to more complex models. Genetic information seems to add little over readily available clinical and metabolic parameters. Risk prediction is utilized in health care delivery to determine lifestyle interventions and behavior modifications that are effective in preventing the onset of Type II diabetes.

Efforts to improve risk prediction have resulted in the marketing of commercially available tests. Intended to determine a 5-year risk prediction the test combines several biomarkers related to pathways associated with type 2 diabetes disease progression. These biomarkers(HgA1C, glucose, insulin, C-reactive protein, ferritin, adinopectin, and interleukin-2 receptor alpha) are combined with age and gender to create the risk score and predict progression to diabetes.

The biomarkers included in these tests (e.g. Pre-Dx®) are not subject to U.S. Food and Drug Administration (FDA) approval. Laboratories performing these tests are subject to Clinical Laboratory Improvement Amendment (CLIA) standards for laboratory testing.




The evidence is insufficient to determine whether the multi-analyte analysis and subsequent assignment of a risk score improve outcomes by targeting preventive interventions to individuals who will benefit most. There are no published studies that evaluate use of the risk score in this manner. It is not known whether this method of risk scoring is as good as or better than other methods for identifying individuals at high risk for diabetes.


Abassi, A., Peelen, L., Corpeleijn, E., van der Schouw, Y., Stolk, R., Spijkerman, A., et al. (2012). Prediction models for risk of developing type 2 diabetes: systematic literature search and independent external validation study.  British Medical Journal. 2012 (345), e5900. (Level 1 Evidence- Independent)

American Diabetes Association.  (2012). Standards of medical care in diabetes . Retrieved April 17, 2013 from

Australian Government, Department of Health and Ageing. (2010). The Australian Type II diabetes risk assessment tool. Retrieved April 16, 2013 from

BlueCross BlueShield Association. Medical Policy Reference Manual. (2:2013). Multianalyte assays with algorithmic analyses for predicting risk of type 2 diabetes(2.04.90). Retrieved April 10, 2013 from BlueWeb. (20 articles and/or guidelines reviewed)

Canadian Task Force on Preventive Health Issues. (2012). Recommendations on screening for type 2 diabetes in adults. Retrieved April 16, 2013 from

Heikes, K., Eddy, D., Arondekar, B., & Schlessinger, L. (2008). Diabetes risk calculator, A simple tool for detecting undiagnosed diabetes and pre-diabetes. Diabetes Care, 31 (5), 1040-1045. (Level 4 Evidence-Independent study)

Li, C., Chien, L., Liu, C., Lin, W., Lee, C., Chen, F., et al. (2011). Prospective validation of American Diabetes Association risk tool for predicting pre diabetes  and diabetes in Taiwan-Taichung community health study. Public Library of Science ONE, 6 (10), e25906. (Level 3 Evidence)

Shaw, J. (2011). Diagnosis of prediabetes. Medical Clinics of North America, 95 (2011), 341-352. (Level 5 Evidence)

United States Preventive Services Task Force. (2008). Screening for type 2 diabetes mellitus in adults. Retrieved April 16, 2013 from

Winifred S. Hayes, Inc. Genetic Test Evaluation (GTE) Report. (2012, November). PreDX® Diabetes Risk Score. Retrieved April 16, 2013 from (35 articles and/or guidelines reviewed)




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