PALO ALTO, Calif.–(BUSINESS WIRE)–CardioDx, a pioneer in
the field of cardiovascular genomic diagnostics, announced results of its
COMPASS (Coronary Obstruction Detection by Molecular Personalized Gene Expression)
trial, which were presented today at the American Heart Association Scientific
Sessions 2011 conference in Orlando,
Fla. This prospective, blinded
multi-center study was designed to provide a third independent validation of
the Corus® CAD blood-based gene expression test for ruling out obstructive
coronary artery disease in lower-risk patients with typical and atypical
presentations of stable chest pain, and to compare the diagnostic performance
of Corus CAD to myocardial perfusion imaging (MPI), a common test that uses a
radioactive agent to evaluate the blood flow and function of the heart.
“COMPASS builds on previous results of the PREDICT
trial. In this real-world patient population, the Corus CAD test demonstrates
very high sensitivity and negative predictive value, enabling clinicians to
rule out patients who do not have obstructive coronary artery disease with high
accuracy,” said Gregory S. Thomas, M.D., M.P.H., clinical professor of medicine
and director of nuclear cardiology education at the University of
California-Irvine School of Medicine, who presented the findings. “The use of
this gene expression test, followed by MPI for higher scores, may optimize
diagnostic performance and utilization of health care resources.”
COMPASS enrolled 537 stable patients with symptoms
suggestive of coronary artery disease who had been referred to MPI at 19 U.S. sites. A
blood sample was obtained in all patients prior to MPI, and Corus CAD gene
expression testing was then performed, with study investigators blinded to
Corus CAD test results. Following MPI, patients were referred either to
invasive angiography or to CT angiography (CTA), gold-standard measurements of
blood vessel lumen anatomy for diagnosis of coronary artery disease. A total of
431 patients were eligible for analysis, having completed gene expression
testing, MPI and either invasive angiography or CTA.
In the COMPASS study, Corus CAD was superior to MPI in
diagnostic accuracy, sensitivity (89 percent vs. 27 percent, p<0.001) and
negative predictive value (96 percent vs. 88 percent, p<0.001) and
demonstrated excellent performance for ruling out obstructive coronary artery
disease relative to both invasive angiography and CTA.1
“Chest pain symptoms account for two percent of all visits
to the doctors office each year,” said Mark Monane, M.D., chief medical
officer of CardioDx. “Corus CAD has now been validated in more than 1,100
patients in three separate studies. For physicians, methods to improve the
diagnosis of symptoms suggestive of coronary artery disease represent a huge
unmet need, and the Corus CAD test may help clinicians make better decisions.
For patients, the test may lead to better diagnostic accuracy as well as
avoidance of unnecessary procedures. For payers, we believe that Corus CAD can
address a major expense category.”
A study published in the March 11, 2010 issue of The New
England Journal of Medicine found that in nearly 400,000 patients who underwent
elective invasive angiographic procedures, 62 percent were found to have no
obstructive coronary artery blockage. The study authors concluded that current
modalities for identifying which patients should undergo elective invasive
coronary angiography to diagnose coronary artery disease have limitations, and
that better methods are needed for patient risk stratification.
About Corus CAD
Corus CAD is the first and only clinically validated blood-based test for
obstructive coronary artery disease. The test involves a routine blood draw
conveniently administered in the clinicians office and does not expose
patients to risks of radiation or imaging agent intolerance. Corus CAD is a
decision-making tool that can help primary care clinicians and cardiologists
rule out obstructive coronary artery disease as the cause of a nondiabetic
patient’s symptoms. It is the only sex-specific test for obstructive coronary
artery disease, accounting for critical biological differences between men and
Findings from the PREDICT validation study of the Corus
CAD gene expression test were published in 2010 in the Annals of Internal
Medicine, the journal of the American College of Physicians. The test has been
honored as a winner of The Wall Street Journals prestigious Technology
Innovation Awards and one of TIMEs Top Ten Medical Breakthroughs.
The Corus CAD test measures the RNA levels of 23 genes from
a whole blood sample. Because these RNA levels are increased or decreased when
obstructive coronary artery disease is present, the Corus CAD score indicates
the likelihood that an individual patient does not have obstructive coronary
Corus CAD is commercially available through an innovative
patient sample kit that includes everything needed for blood collection and
express delivery to the companys CLIA-certified Palo Alto, Calif.
laboratory. Test results are delivered promptly to the clinicians office.
Corus CAD is currently available in the United States.
For more information please visit http://www.cardiodx.com/media-kit/.
About Gene Expression Testing
Gene expression testing provides valuable tissue and cell-specific information
about the molecular mechanisms involved in disease processes, enabling
evaluation of an individual patients disease state, activity, and/or
progression at a given point in time. Unlike genetic tests, which measure
genetic variations, mutations, traits and predispositions-factors that are
constant over a persons lifetime-gene expression testing assesses a dynamic
process, integrating both genetic predisposition and additional behavioral and
environmental influences on current disease state.
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.
1 By ROC analysis.