CardioDx Announces Data Demonstrating the Clinical Utility of Its Gene Expression Test for Obstructive Coronary Artery Disease in Patients 65 or Older
PALO ALTO, Calif.--CardioDx, Inc., a pioneer in the field of cardiovascular genomic diagnostics, today announced results from a study evaluating the impact of the Corus® CAD gene expression test on clinician decision-making in the assessment of patients with suspected obstructive coronary artery disease (CAD) in the primary care setting. Results of the elderly population subanalysis from a previously reported retrospective chart review study were presented at the Gerontological Society of America's 65th Annual Scientific Meeting in San Diego, Calif. by principal investigator Michael Conlin, M.D., of Johns Creek Primary Care in Suwanee, Ga.
The study findings highlight the clinical utility of the Corus CAD test in the geriatric population, showing that Corus CAD enabled primary care clinicians to more effectively assess whether patient symptoms were due to obstructive CAD and to help make cardiology referral decisions. Of the 98 patients studied, a total of 49 (50%) patients were referred to cardiology. The findings showed that that the low-scoring (≤15) Corus CAD patients in the 65 years or older group were 91 percent less likely to be referred to a cardiologist for further CAD assessment compared to the elevated-scoring (>15) Corus CAD patients in the same age group (p<0.001). The median patient age in this study was 72 years old. In the study's six-month follow-up, no patients experienced a major adverse event (death, stroke, heart attack, stent placement, balloon procedure, or bypass surgery).
"The results of this study demonstrate that the Corus CAD test may be incorporated into the primary care practice to help physicians exclude obstructive CAD as the cause of a patient's symptoms in the Medicare patient population," said Dr. Conlin. "The high negative predictive value of the Corus CAD test for obstructive CAD helps clinicians to confidently decide whether or not to refer patients to cardiology for further work-up or to pursue other causes of the patient's symptoms, thus optimizing the delivery of care."
"The results of this study are important because they show that Corus CAD may impact primary care decision-making in the Medicare patient population," said Mark Monane, Chief Medical Officer, CardioDx. "Data continue to confirm that Corus CAD provides a novel, value-added insight into whether or not an individual patient has obstructive CAD. As adoption increases, the Corus CAD test has the potential to yield greater healthcare efficiencies and reduced costs by decreasing noninvasive imaging and associated radiation and dye-induced side effects, as well as potentially reducing invasive coronary angiography in patients with a low likelihood of coronary artery blockages."
In August 2012, Medicare coverage was established for the Corus CAD gene expression test for evaluating patients presenting with typical and atypical symptoms suggestive of coronary artery disease, making the test a covered benefit for more than 40 million Medicare enrollees in the U.S.
About Corus CAD
With a simple blood draw, Corus CAD can safely, accurately and conveniently help primary care clinicians and cardiologists assess whether or not a stable nondiabetic patient's symptoms are due to obstructive coronary artery disease (CAD), enabling many patients to avoid unnecessary invasive procedures and exposure to imaging-related radiation risks or imaging agent intolerance. The test has been clinically validated in multiple independent patient cohorts, including two prospective, multicenter U.S. studies, PREDICT and COMPASS. Additionally, a retrospective, multicenter chart review study and the prospective IMPACT trial at Vanderbilt University demonstrated that Corus CAD use yields statistically significant and clinically relevant changes in patient management decisions in both primary care and cardiology settings. Corus CAD has been used commercially by clinicians in more than 31,000 patients and is a covered benefit for more than 40 million Medicare enrollees in the U.S.
Corus CAD has also 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 Ten Medical Breakthroughs. CardioDx was recently honored as one of FierceMedicalDevices' "Fierce 15" most promising privately held medical device and diagnostic companies.
The Corus CAD test is intended for use in nondiabetic stable patients who present with typical or atypical symptoms suggestive of CAD, with no known history of CAD, have no prior myocardial infarction (MI) or revascularization procedure, and are not currently taking steroids, immunosuppressive agents or chemotherapeutic agents.
CardioDx, Inc., a pioneer in the field of cardiovascular genomic diagnostics, is committed to developing clinically validated tests that empower clinicians to better tailor care to each individual patient. Strategically focused on coronary artery disease, cardiac arrhythmia and heart failure, CardioDx is poised to expand patient access and improve healthcare quality and efficiency through the commercialization of genomic technologies. For more information, please visit www.cardiodx.com.