DESCRIPTION
Obstructive coronary artery disease (CAD) in patients with stable chest pain is typically evaluated by stress echocardiography, myocardial perfusion imaging, and computed tomography angiography. Corus CAD™, developed by CardioDX®, Inc., is a genomic test designed to use in an outpatient setting with clinically stable, non-diabetic patients who present with chest pain or who have a high risk of coronary artery disease but do not have a previously diagnosed myocardial infarction or prior revascularization procedure.
Blood is drawn in the physician’s office and the test is performed in the CLIA-licensed CardioDX® Laboratory. Test results are provided to the physician as a numeric score that quantifies the likelihood that a patient with stable chest pain has obstructive CAD.
POLICY
Gene expression testing to evaluate coronary artery disease is considered investigational.
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member’s health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
There is a lack of available studies to provide comparison to or to determine the clinical importance in use of this test over standard, accepted testing methods. There is no evidence to support use of the gene expression testing to predict clinical events or to alter the treatment of individuals.
Laboratories that conduct genetic testing are regulated under the provisions of the Clinical Laboratory Improvement Act (CLIA), which is administered by the Health Care Financing Administration (HCFA) and the Centers for Disease Control and Prevention (CDC).
SOURCES
American College of Cardiology Foundation/American Heart Association. (2010). 2010 ACCF/AHA Guideline for Assessment of cardiovascular risk in asymptomatic adults: A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Retrieved April 8, 2011 from http://circ.ahajournals.org/cgi/content/full/122/25/2748.
American Heart Association. (2010). Heterogeneity of the phenotypic definition of coronary artery disease and its impact on genetic association studies. Retrieved April 8, 2011 from http://circgenetics.ahajournals.org/content/4/1/58.full.
Cooney, M. T., Dudina, A. L., & Graham I. M. (2009). Value and limitations of existing scores for the assessment of cardiovascular risk: A review for clinicians. Journal of the American College of Cardiology, 54 (14), 1209-1227. (Level 5 Evidence)
Ginsburg, G. S., Shah, S. H., & McCarthy, J. J. (2007). Taking cardiovascular genetic association studies to the next level. Journal of the American College of Cardiology, 50 (10), 930–932. (Level 5 Evidence)
Institute for Clinical Systems Improvement (ICSI). (2010). Diagnosis and treatment of chest pain and acute coronary syndrome (ACS). Retrieved April 11, 2011 from http://guideline.gov/popups/printView.aspx?id=24215.
Miller, D. T., Ridker, P. M., Libby, P., & Kwiatkowski, D. J. (2007) Atherosclerosis: The path from genomics to therapeutics. Journal of the American College of Cardiology, 49 (15), 1589–1599. (Level 5 Evidence)
Robin, N. H., Tabereaux, P. B., Benza, R., & Korf, B. R. (2007). Genetic testing in cardiovascular disease. Journal of the American College of Cardiology, 50 (8), 727–737. (Level 5 Evidence)
Rosenberg, S., Elashoff, M. R., Beineke, P. Daniels, S. E., Wingrove, J. A., Tingley, W. G., et al. (2010). Multicenter validation of the diagnostic accuracy of a blood-based gene expression test for assessing obstructive coronary artery disease in nondiabetic patients. Annals of Internal Medicine, 153, 425-434. (Level 2 Evidence - Industry Sponsored)
ORIGINAL EFFECTIVE DATE: 10/8/2011
MOST RECENT REVIEW DATE: 10/8/2011
ID_BT
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