Interim results support the clinical utility of the Corus CAD test in the assessment of obstructive coronary artery disease

CardioDx, Inc., a molecular diagnostics company specializing in cardiovascular genomics, has announced results from a multi-center, community-based patient registry called the PRESET Registry which found that patients with symptoms of obstructive coronary artery disease (CAD)* and who had low Corus® CAD test scores had an 82% decreased odds of referral for further cardiac evaluation versus patients with elevated Corus CAD test scores.[1]

The Corus CAD test is a blood-based test that integrates age, sex, and gene expression levels into a single score indicating the current likelihood of a significant narrowing or blockage of the coronary arteries. The data was presented at American Heart Association Scientific Sessions 2015 in Orlando, Fl. on November 7-11, 2015.

"Challenges associated with diagnosing obstructive CAD in symptomatic patients can lead to repeat and unnecessary tests and procedures," said Joseph A. Ladapo, M.D., Ph.D., Assistant Professor of Medicine, Department of Population Health and Medicine, NYU School of Medicine and lead author of the study. "The PRESET Registry analysis reinforces the benefits of implementing the age/sex/gene expression score (ASGES) test in the primary care setting for patients and clinicians. With the ASGES test, clinicians are able to safely and efficiently rule-out low-risk patients suspected of having CAD."

The registry study, "Primary Endpoint Results from a Community-Based Registry Evaluating the Use of a Blood-Based Age/Sex/Gene Expression Test in Patients Presenting with Symptoms Suggestive of Obstructive Coronary Artery Disease: the PRESET Registry (A Registry to Evaluate Patterns of Care Associated with the Use of Corus CAD in Real World Clinical Care Settings)," evaluated 718 stable, non-acute and non-diabetic adult patients without a history of obstructive CAD from 21 primary care practices from September 2012 to August 2014.

The interim results of the primary efficacy endpoint demonstrated that the use of the Corus CAD test in the primary care setting was associated with a clinically relevant and statistically significant impact on medical decision making in patients presenting with typical or atypical symptoms suggestive of obstructive CAD. The median test score was 18 (range: 1-40), and 310 of the 718 (43%) patients had low scores ( ≤ 15). In a 30-day follow up, 27 of 310 (9%) patients with low Corus CAD scores were referred for further cardiac evaluation (OR 0.18, p < 0.0001). Follow-up at 30 days after the Corus CAD test revealed a low rate of major adverse cardiovascular events: 2 events were reported among low score patients, both deemed unrelated to study intervention, and longer-term follow-up is pending.

"With approximately $5.9 billion spent annually on non-invasive and invasive cardiac testing among non-diabetic patients in the U.S. we are faced with the challenge to better and more confidently diagnose patients presenting with symptoms suggestive of obstructive CAD," said Mark Monane, M.D., FACP, Chief Medical Officer of CardioDx. "The large number of community-based office practices included in the PRESET registry helps to address the generalizability of the study findings. The results of the primary endpoint showing a low rate of further cardiac referral reinforce results from previous studies showing the clinical utility of Corus CAD on clinical decision making."