project: cardiodx

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Corus CAD Intended Use

The Corus CAD test is a quantitative in vitro diagnostic test performed in a single laboratory, using age, sex, and the gene expression profile of cells found in peripheral blood specimens to help a clinician identify the likelihood that a patient has coronary artery stenosis of at least 50%. The test should be performed on patients with a history of chest pain, with suspected anginal equivalent to chest pain, or with a high risk of coronary artery disease (CAD), but with no known prior myocardial infarction or revascularization procedures. The test is not intended for patients with acute myocardial infarction, high-risk unstable angina, systemic infectious or systemic inflammatory conditions, diabetes, or who are currently taking steroids, immunosuppressive agents, or chemotherapeutic agents.

The test is performed on a blood specimen obtained from the patient. The test incorporates age, sex, and the expression levels of multiple genes using an algorithm with weighted gene expression levels to generate a quantitative score. The results of the test should be used by clinicians in conjunction with other tests and clinical information when assessing a patient's CAD.

The Corus CAD test is for prescription use only. The test is not intended to be used to screen for stenosis among patients who are asymptomatic and not considered at high-risk for CAD, to predict or detect response to therapy, or to help select the optimal therapy for patients.