MEDICAL DEVICE INNOVATION - Medical Device Daily

MEDICAL DEVICE INNOVATION 2010
Corus offers noninvasive
method to assess cardio ills
By OMAR FORD
Medical Device Daily Staff Writer
For years physicians have assessed coronary artery
disease (CAD) by reviewing a patient’s symptoms, medical
history and cardiovascular risk factors, as well as use tests
that yield anatomical and functional information about the
heart and its vessels.
While there have been tremendous advances surrounding
the technologies that treat this disease, the diagnostics
tools used to identify CAD hasn’t quite kept the same pace.
A new test from CardioDX (Palo Alto, California) promises
to give physicians far greater insight on a patient’s
probability of having obstructive CAD. The company
reported launching its Corus CAD test in select states, and
that the test recently completed the PREDICT multicenter
validation study.
Corus CAD at its core is a genomic test that was developed
after physicians expressed dissatisfaction with some
of the shortcomings of imaging tests like stress echocardiography,
myocardial perfusion imaging and computed
tomography angiography.
“We usually take a tremendous amount of time with
physicians before we delve into the R&D phase of our products,”
David Levison CEO and founder of the 5-year-old
CardioDX told Medical Device Daily. “We asked physicians
what were the challenges in the diagnosis and care of coronary
patients.”
The number one response the company received was
that clinicians and doctors were trying to get a more objective
look into identifying and predicting the occurrence of
serious cardio disease, according to Levison.
The company, once finding out what direction it should
go in, started work on proving a hypothesis that there is a
strong correlation between the peripheral blood gene
expression and CAD.
“Physicians said give us a test that has a very high sensitivity
level so they can rule out any patients who might
not be at risk,” he said. “Our test is much more objective in
nature [than imaging tests on the market]. The result is
going to be the same every time you run a sample, and not
necessarily depend on how a clinician views an image.”
To date the company has collected more than 2,800
patient samples through PREDICT from more than 40 clinical
sites in the U.S. Trial results and the Corus CAD validation
data are expected to be presented toward the end of
2009.
Here’s how the test works:
The clinician takes a simple blood sample, without
exposing the patient to radiation, contrasts or dyes and it is
then sent to CardioDx’s CLIA-certified laboratory for gene
expression analysis. CardioDx scientists use quantitative
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real-time polymerase chain reaction (qRT-PCR), a highly
sensitive laboratory process for precise quantification of
gene expression. Validated in a rigorous multi-center trial,
Corus CAD integrates the expression levels of 23 genes
and other patient characteristics empirically shown to indicate
obstructive CAD.
Results are delivered to the physician via a patient
report that includes a numeric score between 0 and 40.
“The higher the score the more likely obstructive coronary
disease could occur in the patient,” Levison told MDD.
He added that the test combines gene expression information
with standard information from clinical assessments
and enables physicians to have a “more complete
picture” of their patient’s disease, and allows for more “individualized”
and “informed” patient care decisions.
As of now the test is only available in nine states
Kentucky, Maryland, Illinois, Washington, Wisconsin,
Minnesota, North Carolina, Texas and Arizona. Plans call for
tests to be administered in more states next year.
“With this test, for the first time physicians have the
biology behind the imaging,” Levison said. “We’ve developed
a test that is very actionable. It’s a test that can give
physicians a [road map] to determine the next course of
action for patients.”
CardioDx is a cardiovascular genomic diagnostics
company providing physicians with clinically validated
tests to enable more informed and individualized patient
care decisions. The company is strategically focused on
developing products for three forms of cardiovascular disease:
CAD, cardiac arrhythmias and heart failure.
(This story originally appeared in the Aug. 27, 2009,
edition of Medical Device Daily)
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