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First Blood Test to Predict Strokes Approved by FDA
June 17, 2005 - The U.S. Food and Drug
Administration (FDA) approved today the first blood test designed to
help predict a patient's risk for ischemic stroke, the most common type
of stroke and one of the nation's leading causes of long-term disability
affecting approximately 700,000 people per year. Baby boomers and senior
citizens over 50 are at the highest risk.
"This test provides a new tool to help us identify
at-risk patients earlier, so we can start therapies in time to prevent a
stroke altogether," said Christie Ballantyne, MD, director of the Center
for Cardiovascular Disease Prevention at the Methodist DeBakey Heart
Center in Houston.
According to the American Stroke Association, 74
percent of Americans do not know the most common warning signs of
stroke:
> Sudden numbness in the arm, leg or face on one or both sides of the
body
> Unexpected severe headache with no apparent cause
> Sudden confusion, trouble speaking or comprehending
> Sudden vision problems, dizziness, and loss of balance or coordination
The PLACTM test, developed by diaDexus, measures a
blood enzyme called lipoprotein-associated phospholipase A2 (Lp-PLA2).
Results from the National Heart Lung and Blood Institute's
Atherosclerosis Risk in Communities (ARIC) study, conducted at the
Methodist DeBakey Heart Center, demonstrated that people with elevated
levels of this enzyme have a twofold risk of suffering an ischemic
stroke associated with atherosclerosis over a period of 6 to 8 years.
These findings are independent of traditional risk factors such as
systolic blood pressure, smoking status and diabetes, body mass index,
as well as levels of C-reactive protein (CRP), a risk factor for
systemic inflammation.
While elevated cholesterol levels are a good
predictor for heart disease, no such relationship has been established
for stroke, even though both are related to blockages in blood vessels.
"Unlike cholesterol levels, Lp-PLA2 was a
significant and independent predictor of ischemic stroke in the ARIC
study," Ballantyne said. "Current guidelines for screening and
prevention of heart disease do not include risk for stroke. The PLAC
test will help physicians more accurately predict who is at risk for
stroke, so that the individual can take proactive and preventative
measures, such as lifestyle modification or therapeutic intervention,
including statins and daily aspirin."
This study was supported by the National Institutes
of Health (NIH) along with funding from GlaxoSmithKline.
About The Methodist Hospital
The Methodist Hospital is one of the nation's largest private,
non-profit general hospitals. Dedicated to providing the highest level
of patient care, Methodist has a 90 year legacy of medical
breakthroughs, such as the world's first multiple-organ transplant in
the 1960s, gene therapy for prostate cancer, and the first islet cell
transplants in Texas. U.S. News & World Report names Methodist among the
country's top hospitals in nine specialties.
Methodist is also home to The Methodist Hospital
Research Institute, which is dedicated to accelerating the process of
translating the best basic research into new treatments for diseases.
About the PLACTM Test
The PLAC test, developed by diaDexus, Inc., was originally
cleared by the FDA as an aid in predicting an individual's risk for
coronary heart disease in July 2003. It is now cleared to aid in the
prediction of an individual's risk for a coronary event and ischemic
stroke associated with atherosclerosis, in conjunction with clinical
evaluation and patient risk assessment. The PLAC test is currently
available through laboratories nationwide, including Quest Diagnostics
Incorporated, Mayo Medical Laboratories, ARUP Laboratories and Berkeley
HeartLab.
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