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CardioDx publishes PREDICT trial results

April 08, 2017

"I see broad potential for a test like Corus CAD to transform the way obstructive coronary artery disease is diagnosed, to the benefit of both clinician and patient," said Alexandra Lansky, M.D., a cardiologist at New York-Presbyterian Hospital-Columbia University Medical Center and director of Clinical Services at its Center for Interventional Vascular Therapy. Dr. Lansky was also an investigator for the PREDICT study. "Patients for whom current testing methods yield less accurate results, including obese patients and women, may especially benefit."

Although experts have long agreed that cardiovascular disease develops and presents differently in women versus men, Corus CAD is the first sex-specific test for obstructive coronary artery disease to directly account for critical biological differences between men and women.

The prospective, blinded, multi-center PREDICT trial was designed to develop and validate gene expression tests that accurately determine the likelihood of obstructive coronary artery disease in stable patients with symptoms suggestive of coronary artery disease. Obstructive coronary artery disease was defined in the study as at least one atherosclerotic plaque causing 50 percent or greater luminal diameter stenosis in a major coronary artery (??1.5mm lumen diameter) as determined by invasive quantitative coronary angiography (QCA).

1,343 non-diabetic patients from 39 U.S. clinical sites, enrolled between July 2007 and April 2009, were included in the development and prospective validation of Corus CAD. All patients had been referred for elective invasive coronary angiography. The patients were classified as cases or controls based on whether they had obstructive coronary artery disease or not, as determined by quantitative coronary angiography (QCA). Blood samples were also collected from the patients, and data from the QCA analysis was then compared to Corus CAD test results to determine test performance. Both QCA technicians and CardioDx analysts were blinded to patient disease status. In the validation study, Corus CAD demonstrated a sensitivity of 85 percent (the probability that someone with a positive test result does indeed have obstructive coronary artery disease) and a negative predictive value of 83 percent (the probability that someone with a negative test result does not have obstructive coronary artery disease).

Source : CardioDx