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CardioDx Presents Comparative Effectiveness Claims Analysis Highlighting the Clinical Value of the Corus® CAD Precision Medicine Blood Test in Elderly Patients at the Gerontological Society of America 2018 Annual Meeting

December 19, 2018

REDWOOD CITY, Calif., Dec. 19, 2018 (GLOBE NEWSWIRE) -- CardioDx, Inc., a molecular diagnostics company specializing in cardiovascular genomics, presented results of a comparative effectiveness claims analysis of Medicare Advantage patients from the Optum, United Healthcare, database during a poster presentation at the Gerontological Society of America Annual Meeting in Boston, MA, on November 14, 2018.

The findings of the claims analysis of 1,421 Medicare Advantage patients demonstrated that the Corus CAD blood test provided clinical value to elderly patients evaluated for obstructive* coronary artery disease (CAD) in real world practice. Medicare Advantage patients who received the Corus CAD test had lower rates of downstream invasive coronary angiography procedures, revascularization procedures, CAD-related clinic and ER visits, and hospitalizations, and had similar major adverse cardiac event rates compared to traditional cardiac testing at follow-up. The 6-month major adverse cardiac event was 0% for the Corus CAD group and 0.6% for the traditional cardiac testing cohort (P=0.3573). Corus CAD is a precision medicine blood test integrating age, sex, and gene expression levels into a single score (1-40 scale) that corresponds to the current likelihood of a significant narrowing or blockage in the heart arteries.

Coronary artery disease is a leading cause of death in the U.S., resulting in one in seven deaths per year.1 Each year, approximately $5.9 billion is spent on non-invasive and invasive cardiac testing of non-diabetic patients (without prior history of revascularization or myocardial infarction) in the US for obstructive CAD. Yet, the evaluation of symptomatic patients for obstructive coronary artery disease remains suboptimal as clinicians are often unable to confidently determine if CAD is the source of their symptoms, thus resulting in unnecessary follow-on, additional cardiac testing and invasive procedures.

The objective of this comparative effectiveness claims analysis was to use insurance claims data (Optum claims database from January 1, 2015 to October 31, 2017) of Medicare Advantage outpatients and to analyze the clinical actions taken in the real-world, clinical practice among elderly patients receiving the Corus CAD test and comparing them to a subset of a cohort matched by clinical and demographic characteristics in patients undergoing traditional cardiac testing who did not receive the Corus CAD test. A total of 1,421 outpatients were included in this analysis, 306 patients in the Corus CAD cohort and 1,115 patients in the traditional cardiac testing (or usual care) cohort from this time period. The results of the claims analysis were remarkable and showed that the frequency of invasive coronary angiography was 70% lower in the Corus CAD cohort at 6-month follow-up versus traditional cardiac testing (2.6% vs. 8.6%; P<0.0001). Similarly, rates of CAD-related clinic, emergency room visits and hospital stays were 51% lower in the Corus CAD cohort at 6-months (3.6% vs. 7.4%, respectively; P=0.0257), and the rates of coronary artery revascularization was 89% lower in the Corus CAD cohort at 6-month follow-up versus traditional cardiac testing (0.3 vs. 2.8%; P=0.0029).

The study concluded that in real-world clinical practice, the Corus CAD test provided clinical utility and value to stable, elderly patients with symptoms suggestive of obstructive CAD. The reduced CAD-related healthcare utilization with similar major adverse cardiac event rates in the Corus CAD cohort versus control patients of traditional cardiac testing suggests that Corus CAD may add to the efficiency of care in the workup of symptomatic elderly outpatients undergoing the assessment for obstructive coronary artery disease.

About Obstructive Coronary Artery DiseaseCoronary artery disease (CAD) is a very common heart condition in the United States. One in seven deaths among Americans is caused by CAD.1 CAD can cause a narrowing or blockage of the coronary arteries (vessels to the heart that supply the heart with blood, oxygen, and nutrients), reducing blood flow to the heart muscle. This narrowing or blockage in the coronary arteries is often referred to as obstructive CAD, characterized by the presence of atherosclerosis, or plaque.

About the Corus CAD TestCorus CAD is the first and only commercially available blood test that can safely and conveniently help primary care clinicians and cardiologists assess stable non-diabetic patients’ symptoms for obstructive coronary artery disease. The test incorporates age, sex and gene expression measurements into a single score that indicates the likelihood of obstructive CAD. Clinicians use the Corus CAD score, along with other clinical information, to determine whether further cardiac testing is necessary, which can help patients avoid unnecessary exposure to radiation associated with medical imaging testing, as well as possible reactions to imaging dyes and/or potential complications from invasive cardiac procedures. The test involves a routine blood draw that is conveniently administered in the clinician’s office. The Corus CAD test is the only sex-specific test for the evaluation of obstructive CAD because it accounts for cardiovascular differences between men and women.

The test has been clinically validated in independent male and female patient cohorts, including two prospective, multicenter U.S. studies, PREDICT and COMPASS.2,3 In the COMPASS study, the Corus CAD test outperformed myocardial perfusion imaging (MPI) as a diagnostic tool to exclude obstructive CAD by demonstrating a higher negative predictive value (96% vs. 88%, p<0.001) than MPI for assessing the presence of obstructive CAD.3,4 In the NHLBI-sponsored PROMISE Corus CAD substudy, Corus CAD demonstrated similar clinical outcomes to MPI and coronary CT-angiography at 25 months follow-up (3.2% vs. 2.6%, p=0.29). 5 To date, over 275,000 Corus CAD test results have been resulted and provided to clinicians commercially. CardioDx processes all Corus CAD test samples at its CLIA-certified and CAP-accredited clinical laboratory in Redwood City, California.

The Corus CAD test has been recognized by The Wall Street Journal’s Technology Innovation Awards, honored as a Gold Edison Award recipient, and named one of TIME’s Top 10 Medical Breakthroughs in 2010.

About CardioDxCardioDx, Inc., a molecular diagnostics company specializing in cardiovascular genomics, is committed to developing clinically validated tests that empower clinicians to better tailor care to each individual patient. Strategically focused on coronary artery disease, CardioDx is committed to expanding patient access and improving healthcare quality and efficiency through the commercialization of genomic technologies. Please visit www.cardiodx.com for additional information.

For media inquiries, please contact media@cardiodx.com.

* Obstructive CAD is defined as at least one atherosclerotic plaque causing ≥50% luminal diameter stenosis in a major coronary artery (≥1.5 mm lumen diameter) as determined by invasive quantitative coronary angiography (QCA) or coronary computed tomography angiography (CTA) (≥2.0 mm).

References

1 Benjamin EJ, Virani SS, Callaway CW, et al. On Behalf of the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics – 2018 Update: A Report from the American Heart Association. Circulation. 2018;137:e67-e492.2 Rosenberg S, Elashoff MR, Beineke P, et al. Multicenter Validation of the Diagnostic Accuracy of a Blood-Based GeneExpression Test for Assessing Obstructive Coronary Artery Disease in Nondiabetic Patients. Ann Intern Med. 2010;153:425-434.3 Thomas GS, Voros S, McPherson JA, et al. A Blood-Based Gene Expression Test for Obstructive Coronary Artery Disease Tested in Symptomatic Nondiabetic Patients Referred for Myocardial Perfusion Imaging: The COMPASS Study. Circ Cardiovasc Genet. 2013;6(2):154-162.4 The COMPASS study demonstrated that the Corus CAD algorithm has an NPV of 96% and 89% sensitivity at the score threshold of 15 in a population of men and women referred to MPI.5 Voora D, Coles A, Lee KL, et al. An Age- and Sex-Specific Gene Expression Score is Associated With Revascularization and Coronary Artery Disease: Insights From the Prospective Multicenter Imaging Study for Evaluation of Chest Pain (PROMISE) Trial. Am Heart J. 2017;184:133-140.

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