AHA Deems Test Valid and Useful for Clinicians Evaluating Obstructive CAD

CardioDx Inc., a molecular diagnostics company specializing in cardiovascular genomics, announced today that in a Scientific Statement by the American Heart Association, the Corus CAD blood test was evaluated and “deemed to be valid and useful” in the workup of patients with suspected coronary artery disease (CAD).¹ CAD is one of the leading causes of death in the U.S. resulting in one in seven deaths.²
 
Published in the peer-reviewed journal, Circulation: Cardiovascular Genetics, the AHA Scientific Statement, The Expressed Genome in Cardiovascular Disease and Stroke: Refinement, Diagnosis, and Prediction: A Scientific Statement From the American Heart Association,¹ discussed how the expressed genome can now, and in the future, be used to diagnose and predict cardiovascular disease and manage patient treatment. The statement then highlighted two commercially available technologies stemming from this research.
 
“Since the human genome was sequenced 14 years ago, significant advancements have been made in the field of expressed genome research,” said Kiran Musunuru, M.D., Ph.D., the statement’s lead author and associate professor of Cardiovascular Medicine and Genetics at the University of Pennsylvania. “The AHA convened a panel of experts to review, evaluate and publish the state of the science in the diagnosis and prediction of cardiovascular disease with these technologies. We are optimistic that their use and application will continue to grow, enabling their widespread adoption and progress in this field. Our work identified two available tests that had generated sufficient data to be included in our review, including Corus CAD.”
 
Corus CAD is the only clinically validated blood test that uses age, sex and gene expression to measure the current likelihood of obstructive coronary artery disease* (CAD) in symptomatic patients. The test was validated in both the PREDICT³ and COMPASS⁴ clinical studies. And the results were then independently confirmed in a third study—the NHLBI-sponsored PROMISE Corus CAD substudy.⁵ With a 96 percent negative predictive value, the Corus CAD test is a simple blood test that incorporates age, sex, and gene expression measurements into a single score (1-40 scale) corresponding to the current likelihood of obstructive CAD.^4,6
 
“We are delighted that the American Heart Association highlighted the clinical value of the Corus CAD test in the recent Scientific Statement,” says Khush F. Mehta, president and chief executive officer of CardioDx. “With Corus CAD, CardioDx is delivering on the promise of the human genome by empowering clinicians with enhanced solutions for better patient care.”
 
* Obstructive CAD is defined as at least one atherosclerotic plaque causing ≥50 percent 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 Musunuru K, Ingelsson E, Fornage M, et al. The Expressed Genome in Cardiovascular Diseases and Stroke: Refinement, Diagnosis, and Prediction: A Scientific Statement From the American Heart Association. Circ Cardiovasc Genet.2017;10(4):e1-e25.
² Benjamin EJ, Blaha MJ, Chiuve SE, et al. On Behalf of the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics – 2017 Update: A Report from the American Heart Association.Circulation. 2017;135(10):e146-e603.
³ Rosenberg S, Elashoff MR, Beineke P, et al. Multicenter Validation of the Diagnostic Accuracy of a Blood-Based Gene Expression Test for Assessing Obstructive Coronary Artery Disease in Nondiabetic Patients. Ann Intern Med. 2010;153:425-434.
⁴ 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.
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. 
⁶ The COMPASS study demonstrated that the Corus CAD algorithm has an NPV of 96 percent at the pre-specified threshold of 15 in a population of men and women referred to MPI.