Obstructive coronary artery disease (CAD) in individuals 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.
The 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 the individual with stable chest pain has obstructive CAD.
Gene expression testing to evaluate coronary artery disease is considered investigational.
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
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.
There is a lack of available studies to determine the clinical importance of this test over standard, accepted testing methods. There is a lack of evidence to support the use of the gene expression testing to predict clinical events or to alter the treatment of individuals.
American Heart Association. (2016). Enhancing literacy in cardiovascular genetics: A scientific statement from the American Heart Association. Retrieved October 4, 2016 from http://circgenetics.ahajournals.org/.
American Heart Association. (2012). Genetics and cardiovascular disease. A policy statement from the American Heart Association. Retrieved September 6, 2017 from http://www.heart.org/HEARTORG/Advocate/Our-Policy-Positions_UCM_450349_Article.jsp#.WbAck7uosdU.
American Heart Association. (2017). The expressed genome in cardiovascular diseases and stroke: refinement, diagnosis, and prediction: a scientific statement from the American Heart Association. Retrieved November 10, 2017 from https://professional.heart.org/professional/GuidelinesStatements/UCM_316885_Guidelines-Statements.jsp.
BlueCross BlueShield Association. Medical Policy Reference Manual. (1:2017). Gene expression testing in the evaluation of patients with stable ischemic heart disease (2.04.72). Retrieved September 1, 2017 from BlueWeb. (19 articles and/or guidelines reviewed)
Daniels, S. E., Beineke, P., Rhees, B., McPherson, J. A., Kraus, W. E., Thomas, G. S., et al. (2014). Biological and analytical stability of a peripheral blood gene expression score for obstructive coronary artery disease in the PREDICT and COMPASS studies. Journal of Cardiovascular Translational Research, 7 (7), 616-622. (Level 2 evidence)
Filsoof, D. M., Safford, R. E., Newby, K. Rosenberg, S., Kontras, D. G., Baker, A., et al. (2015). Impact of exercise stress testing on diagnostic gene expression in patients with obstructive and nonobstructive coronary artery disease. American Journal of Cardiology, 115 (10), 1346-1350. Abstract retrieved November 6, 2015 from PubMed database.
Ladapo, J. A., Herman, L., Weiner, B. H., Rhees, B., Castle, L., Monane, M., et al. (2015). Use of a blood test incorporating age, sex and gene expression influences medical decision-making in the evaluation of women presenting with symptoms suggestive of obstructive coronary artery disease: summary results from two ambulatory care studies in primary care. Menopause: The Journal of the North American Menopause Society, 22 (11), 1-7. (Level 2 evidence)
Ladapo, J. A., Lyons, H., Yau, M., Rich, P., Newton, D., Bruce-Mensah, K., et al. (2014). Enhanced assessment of chest pain and related symptoms in the primary care setting through the use of a novel personalized medicine genomic test. American Journal of Medical Quality, 30 (4), 345-352. (Level 2 evidence)
Palmetto GBA. (2017). Approved gene testing (M00041, V16). Retrieved September 6, 2017 from https://www.palmettogba.com/palmetto/moldx.nsf/docscat/MolDx%20Website~MolDx~Browse%20By%20Topic~General~Approved%20Gene%20Testing%20(M00041%20V16)
Rosenberg, S., Elashoff, M. R., Lieu, H. D., Brown, B. O., Kraus, W. E., Schwartz, R. S., et al. (2012). Whole blood gene expression testing for coronary artery disease in nondiabetic patients: major adverse cardiovascular events and interventions in the PREDICT trial. Journal of Cardiovascular Translational Research, 5 (3), 366-374. (Level 1 evidence)
ORIGINAL EFFECTIVE DATE: 10/8/2011
MOST RECENT REVIEW DATE: 10/26/2017
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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