Corus CAD test can help clinicians rule-out low-risk patients from additional cardiac testing

May 20 2015

Patients With Low Corus CAD Test Scores Had an 82% Decreased Odds for Further, Potentially Unnecessary Referral for Further Cardiac Evaluation

CardioDx, Inc., a molecular diagnostics company specializing in cardiovascular genomics, announced today results from a multi-center, community-based patient registry, the PRESET Registry, evaluating the use of the Corus^® CAD test in patients with symptoms suggestive of obstructive coronary artery disease (CAD) in the primary care setting. 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. Published online as an abstract in the May 2015 supplement of Circulation: Cardiovascular Quality and Outcomes, the study found that patients with low Corus CAD test scores had an 82% decreased odds of referral for further cardiac evaluation.

"Data from recent studies suggest that physicians have a challenging time accurately risk stratifying patients presenting with stable symptoms suggestive of obstructive CAD," 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. "Our analysis of the PRESET Registry demonstrates that using the score that incorporates age, sex, and gene expression in a primary care setting in patients with symptoms suggestive of obstructive CAD can help clinicians safely and efficiently rule-out low-risk patients."

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 adult patients without a history of obstructive CAD from 21 primary care practices from September 2012 to August 2014.

The analysis of the primary efficacy endpoint indicated that the adoption of the Corus CAD test into the clinical practice 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 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 to cardiology or advanced diagnostic testing, while 143 of 408 (35%) patients with elevated scores were referred (OR 0.18, p < 0.0001).

"This study is an important addition to the growing collection of clinical utility studies, on Corus CAD in cardiology and primary care. The PRESET Registry incorporated 21 clinical sites from community-based settings, adding to the generalizability of the previous study findings on the impact of the age, sex, gene expression score in clinician decision-making," said Mark Monane, M.D., FACP, Chief Medical Officer of CardioDx. "By integrating the Corus CAD test into the primary care setting and diagnostic workup, clinicians may decrease potentially unnecessary referral of low risk patients to cardiology or further cardiac testing, thus reducing patient exposure to unnecessary procedural risks and avoiding additional costs to the healthcare system."