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Lipid Panel/ASCVD (Atherosclerotic Cardiovascular Disease) Risk Panel
   Lipid Panel/ASCVD (Atherosclerotic Cardiovascular Disease)
     Risk Panel Assessment 92052(X)
   Lipid Panel 91716(X)
   Lipid Panel With Direct LDL Reflex 92061(X)
Lipoprotein Subfractionation
   Ion Mobility 91604(X)
Apolipoproteins
   Apo B 91726(X)
   Lp(a) 91729(X)
Inflammation
   Fibrinogen 91743(X)
   Hs-CRP 91737(X)
   Lp-PLA2 94218(X)
Heart Failure
   NT-proBNP 91739(X)
   ST2, Soluble (sST2) 91823(X)
Metabolic Markers
   Diabetes Risk Panel 92026(X)
   Glucose 91947(X)
   Hemoglobin A1c 91732(X)
   Homocysteine 91733(X)
   Insulin 91731(X)
   Omega-3 and -6 Fatty Acids (Fas) 91734(X)
   Vitamin D, 25 Hydroxy, LC/MS/MS 91735(X)
Genetic Cardiovascular Markers
   4q25 AF Risk Genotype Test 90948(X)
   9p21 Genotype Test 90668(X)
   Apolipoprotein E (Apo E) Genotype Test 90649(X)
   CYP2C19 Genotype Test 90668(X)
   KIF6 Genotype Test 90645(X)
   LPA Aspirin Genotype Test 90553(X)
   LPA Intron 25 Genotype Test 90655(X)
 

Lipid Panel/ASCVD (Atherosclerotic Cardiovascular Disease) Risk Panel

Lipid Panel/ASCVD Risk Panel Assessment 92052(X) calculates a 10-year risk of a first ASCVD event, defined as coronary death or nonfatal myocardial infarction, or fatal or nonfatal stroke using race- and sex-specific pooled cohort evaluations, and as recommended by the 2013 ACC/AHA Guidelines on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults. Patient information is provided by the ordering physician. ASCVD risk panel is a lipid panel with a reflex to direct LDL cholesterol (when triglycerides are high).

Lipid Panel With Direct LDL Reflex 92061(X) and Without Direct LDL Reflex 91716(X) is a panel of blood tests that serves as an initial broad medical assessment tool for abnormalities in total cholesterol, HDL cholesterol, triglycerides, LDL-cholesterol (calculated), and cholesterol/HDL ratio (calculated). A lipid panel is used to identify hyperlipidemia, which may indicate an increased risk for CVD. If the triglyceride level is greater than 400 mg/dL, a measure of direct LDL is done. The LDL direct test, unlike what is reported in the chemistry profile, is not a calculation but rather a direct test for the best evaluation and monitoring of this risk factor.
 

Lipoprotein Subfractionation

lon Mobility 91604(X) is a proprietary test for lipoprotein subfractionation. Individual lipoprotein subclasses are separated with high resolution, and direct quantification of lipoproteins provides precise particle counts for each lipoprotein type and its subclasses. Even if LDL or HDL conventional lipid panel results are normal, LDL and HDL subclass analysis may indicate increased CVD risk.

Small LDL trait reflects the presence of predominantly small LDL particles that are highly atherogenic, and are characterized as small and medium LDL subclasses by Ion Mobility. There is a 1.3x increased CVD risk associated with the small LDL trait and a 1.4x increased risk for the medium LDL trait. The large HDL subclass is the most efficient cholesterol reabsorbing HDL particle and best reflects the efficacy of the reverse cholesterol transport system and cholesterol clearance by the liver. Low levels of large HDL are correlated with a 1.8x increased CVD risk.
 

Apolipoproteins

Apo B 91726(X) is the predominant apoprotein attached to LDL, intermediate-density lipoproteins (IDL), and very low-density lipoproteins (VLDL). Several decades of scientific literature support the measurement of Apo B for monitoring response to statin therapy. Elevated Apo B is associated with a 2.0-2.5x increased CVD risk.

Lp(a) 91729(X) is an inherited abnormal protein attached to LDL. Elevated Lp(a) is associated with increased coagulation and a 1.5-5.3x increased incidence of CVD. Lp(a) has been linked to the promotion of both early and advanced stage atherosclerosis. Combined with other abnormal disease markers, the associated risk increases further.
 

Inflammation

Fibrinogen 91743(X) is a plasma glycoprotein that can be transformed into a fibrin clot in response to vascular or tissue injury. The combination of elevated fibrinogen with other CVD risk factors produces an additive risk and can substantially increase disease potential.

hs-CRP 91737(X) is a highly sensitive measurement of CRP, an acute-phase reactant protein that increases in response to inflammatory stimuli. In large epidemiologic studies, elevated levels of CRP have been shown to be a strong indicator of CVD. Patients with high CRP have a 1.5-2.0x increased risk of developing subsequent atherosclerotic disease compared with patients with low CRP levels.

Lp-PLA2 94218(X) is an enzyme that plays a causal role in the vascular inflammatory process, leading to the formation of vulnerable, rupture-prone plaque. Lp-PLA2 Activity measures the disease activity within the arterial wall under the calcified cap of the plaque. Elevated Lp-PLA2 Activity has been associated with a 2x increased risk for developing coronary heart disease (CHD) at 7 years independent of non-HDL cholesterol levels. Also, elevated Lp-PLA2 Activity levels indicate a 2x risk of having a CHD event (MI, coronary revascularization or CHD-related death) at 5 years.
 

Heart Failure (HF)

NT-proBNP 91739(X): Elevated levels indicate the presence of ongoing myocardial stress and potentially an underlying cardiac disorder. NT-proBNP is an endogenously produced neurohormone secreted from the cardiac ventricular myocytes in response to cardiac stress. As a highly sensitive marker for cardiac dysfunction, elevated NT-proBNP levels are prognostic of future cardiovascular events, even in the setting of undiagnosed, subclinical CVD.

ST2, Soluble (sST2) 91823(X) can be used in the risk assessment of patients with acute and chronic heart failure. The sST2 biomarker binds and removes lnterleukin-33 from the circulation, thus eliminating the protective effect the JL-33 provides to the cardiac muscle. Patients with HF and elevated sST2 levels are at increased risk for progression, heart transplantation, and possibly death. sST2 is not affected by confounding factors as is BNP/NT-proBNP. Using both sST2 and NT-proBNP can help improve the risk stratification of patients with chronic HF. High levels of both sST2 and NT-proBNP, compared with high levels of only one, better predict progression.
 

Metabolic Markers

Diabetes Risk Panel 92026(X) measures glucose, hemoglobin A1c (HbA1c) and lipids. It also estimates the 8-year risk of developing diabetes using laboratory test results, anthropomorphic data, and family history. The risk algorithm is based on the analysis of 3453 individuals (ages 30-79) within the Framingham cohort. It is intended to aid in the identification of patients at risk for developing diabetes mellitus, permitting pharmacological or lifestyle interventions.

Glucose 91947(X) measures serum glucose levels under fasting conditions. Elevated serum glucose (hyperglycemia) is associated with diabetes and insulin resistance. Low levels indicate hypoglycemia.

Hemoglobin A1c 91732(X) reflects average blood sugar levels over the preceding 90-day period. Elevated levels are associated with prediabetes and diabetes. HbA1c measurement requires no fasting or glucose loading requirement, is less sensitive than glucose to stress and illness, and is more specific for identifying individuals at increased risk for diabetes. Lowering HbA1c levels by 1% reduces the risk of microvascular complications by approximately 40%.

Homocysteine 91733(X) is a metabolic by-product of methionine metabolism. Progressively elevated blood levels of homocysteine are a documented risk marker for CVD events.

Insulin 91731(X) is associated with the characterization of atherogenic lipid profile and metabolic syndrome. Abnormal fasting insulin, especially when combined with other risk factors, identifies patients at significantly higher risk for the development of CVD.

Omega-3 and -6 Fatty Acids (FAs) 91734(X): A diet rich in Omega-3 fatty acids is associated with a decreased risk of cardiovascular events, including sudden cardiac death (SCD). The 3 major Omega-3 fatty acids are eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), and alpha-linolenic acid. Omega-6 fatty acids are proinflammatory and prothrombotic. The major Omega-6 fatty acid is arachidonic acid (AA). The Omega-3 index, EPA and DHA expressed as a percentage of phospholipid FAs, is an indicator of risk for SCD and nonfatal cardiovascular events and as a therapeutic target. The EPA/AA ratio is a marker of cardiovascular risk, with higher ratios being associated with lower cardiac risk.

Vitamin D, 25 Hydroxy, LC/MS/MS 91735(X): Low levels are associated with increased risk of CVD events, myocardial infarction (MI), and death due to HF, SCD, and stroke. The cardiovascular impact of low vitamin D is via activation of the renin-angiotensin-aldosterone system, as well as via increased parathyroid hormone levels (which predispose individuals to increased insulin resistance associated with diabetes, hypertension, inflammation, and increased cardiovascular risk).

LC/MS/MS=liquid chromatography/tandem mass spectometry.
 

Genetic Cardiovascular Markers

4q25 AF Risk Genotype Test 90948(X) may help predict risk of atrial fibrillation (AF) and cardioembolic (CE) stroke. 4q25 AF risk carriers may have up to a 1.7x increased risk of AF and up to a 1.5x increased risk of CE stroke related to AF.* Physicians may benefit from knowledge of their patients' increased AF risk, and therefore consider additional clinical follow-up for these patients.

9p21 Genotype Test 90648(X) may help predict risk of early onset myocardial infarction (early Ml), abdominal aortic aneurysm (AAA), and MI/CHD. Identification of 9p21 carriers may allow clinicians to take steps to characterize and reduce risk factors that may contribute to the development or progression of disease.

Apolipoprotein E (ApoE) Genotype Test 90649(X) may help predict risk of CVD and response to different diets.

CYP2C19 Genotype Test 90668(X) may help predict response to Plavix® (clopidogrel). Patients carrying 1 or 2 copies of nonfunctional alleles may not receive the full benefits of Plavix and therefore may benefit from alternative dosing strategies or an antiplatelet agent other than Plavix.

KIF6 Genotype Test 90645(X) may help predict risk of a CHD event and response to Lipitor® (atorvastatin) or Pravachol® (pravastatin).§ In certain studies, atorvastatin and pravastatin therapy was found to reduce CHD event risk more effectively in KIF6 carriers compared with noncarriers.

LPA Aspirin Genotype Test 90553(X) may help predict risk of CVD and response to aspirin therapy.ll In the Women’s Health Study (WHS), low-dose aspirin therapy resulted in a greater reduction of CVD events in LPA Aspirin carriers than in noncarriers.

LPA-lntron 25 Genotype Test 90655(X) may help predict risk of CHD, providing additional insight into a patient’s risk for CHD beyond traditional risk factors.#
 

 

 

 

*Being a carrier of this genetic risk factor does not mean that patient will develop AF or CE stroke. Similarly, patients who are noncarriers of this genetic risk factor are not immune to these heart disorders.
Being a carrier of this genetic risk factor does not mean that patient will develop early MI or AAA. The 9p21 genetic variant has been found to be associated with risk of AAA, but not rate of aneurysmal expansion or risk of rupture.
The clinical impact of the CYP2C19 genotype on the metabolism of specific drugs will vary based on nongenetic factors, such as hepatic and renal status, other medications used (including over-the-counter medications, herbals, and other supplements), alcohol or illegal drug use, race, age, weight, diet, and diseases present in an individual patient.
§The benefit of statin therapy has only been observed with atorvastatin and pravastatin therapy. Other studies of simvastatin and rosuvastatin indicate that this benefit is not generalizable to all statins.
llAspirin therapy has only been studied with low-dose (100 mg) aspirin taken orally on alternate days.
#Study populations predominantly consisted of Caucasian men and women in Europe. LPA-Intron 25-associated risk has not been studied in African-American, Mexican-American, or East Asian populations. However, carrier frequencies in these ethnic groups are approximately 2 percent in African-American and Mexican-American populations, and <1 percent in East Asian populations.

Current supporting data for relevance of specific genetic tests may be limited to certain patient populations. Physicians should request and review the relevant product sheets before recommending a particular test as part of a patient’s risk reduction plan.

The KIF6 Genotype Test, LPA Aspirin Genotype Test, LPA-Intron 25 Genotype Test, 4q25 AF Risk Genotype Test, 9p21 Genotype Test, and CYP2C19 Genotype Test were developed and their performance characteristics determined by Quest Diagnostics, a CLIA-certified and CAP-accredited laboratory. These tests have not been cleared or approved by the US FDA.

Plavix is a registered trademark of Bristol-Myers Squibb.
Lipitor is a registered trademark of Pfizer.
Pravachol is a registered trademark of Bristol-Myers Squibb.