FACT SHEET:  THE VAP^® CHOLESTEROL TEST

Introduction

• One of the key tools used to identify and manage heart disease—the routine cholesterol test—fails to identify about half of the patients who require treatment.
• In contrast, the VAP (Vertical Auto Profile) Test from Atherotech, Inc., is an expanded cholesterol profile that identifies a far greater number of people at risk.
• Routine cholesterol tests measure total cholesterol, HDL (high-density lipoprotein, the “good” cholesterol), and triglycerides, and calculate LDL (low-density lipoprotein, the “bad” cholesterol).
• Just as technology advances in the 1980s allowed total cholesterol to be broken down into HDL and LDL, the VAP Test technology now allows the measurement of basic cholesterol information provided by the routine test, plus a range of cholesterol “subclasses” which play significant roles in the development of heart disease.
• Important cholesterol subclasses measured by the VAP Test include IDL (intermediate-density lipoprotein), HDL subtypes (HDL₂ and HDL3), VLDL (very low-density liproprotein), and LDL pattern density, plus hereditary factors such as lipoprotein(a) [Lp(a)], known as the “widow maker.”
• The VAP Test is the first routine cholesterol test to directly measure LDL, the National Cholesterol Education Program’s (NCEP) primary target of therapy, and include the program’s secondary and emerging risk factors—new information that allows the identification of patients who were underdiagnosed or misdiagnosed with the conventional cholesterol profile.
• The VAP Test also is the first new cholesterol test in 30 years to be available nationwide through national and regional diagnostic laboratories; it is reimbursed by most insurance carriers, including Medicare.
• The broad availability of the VAP Cholesterol Test, combined with more sophisticated treatments, sets the stage for a dramatic improvement in the diagnosis and management of heart disease and other cardiovascular diseases in this country.

Key Benefits of the VAP Cholesterol Test

• Direct Measurement of LDL Cholesterol—The routine cholesterol test calculates LDL using a formula that may underestimate LDL by up to 20 percent, interfering with physicians’ ability to accurately assess and treat their patients’ heart disease risk. The VAP Test is based on ultracentrifugation—the “gold standard” method of measuring cholesterol, providing the accurate, directly measured LDL readings physicians require.
• Setting Correct LDL Goal—A priority for physicians is setting the correct LDL goal for their patients. LDL targets, which can be as low as 70 mg/dL for very high-risk patients, are established by the NCEP based on the existence of a variety of risk factors. However, doctors may need to lower these LDL targets for many patients who have additional cholesterol abnormalities which place them in a higher risk category. These abnormalities, including elevated lipoprotein(a) and small, dense LDL particles, are measured by the VAP Test, but not by routine cholesterol tests.
• Identifying the Metabolic Syndrome—The VAP Cholesterol Test helps doctors diagnose patients with the metabolic syndrome—a dangerous precursor to diabetes—by identifying the “atherogenic lipid triad” of low HDL, elevated triglycerides, and small, dense LDL particles. Patients with the metabolic syndrome are rapidly growing in number and are at significantly increased risk of heart disease, making the identification and treatment of the condition a high priority for the medical community.

Why Measure Cholesterol Subclasses?

• In the National Heart, Blood, and Lung Institute’s Framingham Heart Study, 80 percent of patients who had heart attacks had routine cholesterol test results identical to those who did not experience a heart attack. The VAP Test uncovers “hidden” heart disease risks not detected by routine tests.
• Measurement of LDL pattern density is critical because patients with small, dense LDL (“Pattern B”) have a four-fold increased risk of developing heart disease.
• Elevated Lp(a) can increase heart disease risk by up to 70 percent.
• HDL₂ is the most protective form of HDL, and low HDL₂ is a risk factor for heart disease, even in patients with normal total HDL.
• Research has shown that IDL and VLDL are independent risk factors for heart disease.
• The American Heart Association estimates that direct and indirect costs associated with heart disease in the United States totaled $142.1 billion in 2005. This estimate includes surgical procedures such as bypass surgery and angioplasty—procedures that may be avoided by using the VAP Test to improve early diagnosis and treatment of patients at risk for heart disease.

How the VAP Test Works

• Obtaining a VAP Test is as easy as getting a routine cholesterol test. Physicians simply refer their patients to a local clinical lab for a blood sample, which is sent to Atherotech’s Clinical Laboratory Improvement Act (CLIA)-approved lab in Birmingham for processing.
• The VAP Test’s sophisticated laboratory process spins the blood sample in an ultracentrifuge and divides the different subclasses of lipoproteins by weight. The system then measures the amount of each type of lipoprotein in the sample.
• VAP Test results are presented in a comprehensive, easy-to-read patient profile that highlights abnormal values for physicians.
• VAP Test results are generally available through the physician’s lab or from Atherotech within 72 hours after their arrival in our lab for processing.
• The VAP Test also is available through numerous corporate wellness and direct-to-consumer testing programs, including the “Get a VAP” website (www.getavap.com).

Clinical Studies

• Atherotech is committed to the ongoing clinical study of the VAP Test at leading institutions.
• A landmark study conducted at the University of Virginia School of Medicine showed that the VAP Test guides physicians toward customized drug therapy to fix multiple cholesterol abnormalities, potentially reducing cardiovascular event rates by up to 70 percent.
• The VAP Test also has been used in clinical studies sponsored or conducted by major pharmaceutical companies that market cholesterol-lowering statins and drugs for the metabolic syndrome.
• The VAP Test also is available to all of the major clinical development service companies which conduct or facilitate clinical studies for pharmaceutical companies leading up to Food & Drug Administration regulatory submissions.
• The VAP Test was named one of “Ten Ways to Live Longer” by Forbes.com, and was selected as one of “Five Tests Worth Paying for” by The Wall Street Journal.

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