Cardio IQ Managing Residual Risk with Advanced Cardiovascular Insights

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1 Cardio IQ Managing Residual Risk with Advanced Cardiovascular Insights

2 The Cardio IQ Report Key Attributes Test Results are shown in Optimal, Moderate, or risk categories and are color-coded to display progressive risk values. Historic results of previous tests are provided with the Cardio IQ report to help monitor patient progress. Age: 60 Fasting: Y Gender: M Collected 04/04/2014 Cardio IQ Optimal Moderate 12/18/13 Optimal Moderate Lipid Panel CHOLESTEROL, TOTAL 166 < >=240 HDL CHOLESTEROL 61 >=40 <40 TRIGLYCERIDES 81 < >=200 LDL-CHOLESTEROL 89 < >129 CHOL/HDLC 2.7 <= >5.0 NON-HDL CHOLESTEROL 105 < >159 Direct LDL 55 < >129 Lipoprotein Subfractions LDL PARTICLE NUMBER nmol/l 2000 < >1538 LDL SMALL nmol/l 300 < >217 LDL MEDIUM nmol/l 400 < >271 HDL LARGE nmol/l 8500 > <6996 Apolipoproteins APOLIPOPROTEIN A1 77 > <94 APOLIPOPROTEIN B 80 < >109 APOLIPOPROTEIN B/A < >1.30 LIPOPROTEIN (a) nmol/l 61 < >=160 Inflammation HS CRP mg/l 4.5 < >3.0 LP PLA2 (PLAC ) ng/ml 218 < >234 FIBRINOGEN ANTIGEN 370H <=350 >350 Heart Failure ProBNP pg/ml 503 <= >=900 ST2, SOLUBLE ng/ml 46 <=35 >35 4myheart Diet & Exercise Coaching Program: Need help achieving and maintaining an optimal weight? Managing stress? Trying to improve physical fitness levels? The 4myheart program provides support and personalized lifestyle guidance to help improve heart health. Please talk to your provider, visit 4myheart.com or call opt 2 to learn more. Medical Information for Healthcare Providers: If you have any questions about any of the tests in our Cardio IQ offering, please call opt 3 to speak to a clinical liaison. For frequently asked questions, you can also visit us at Note: This example represents the resulting report for an order of 92063, the Diabetes & ASCVD Risk Panel, which includes lipid panel components, ASCVD risk scores, glucose and HbA1c value and assessment with diabetes risk scores. This report format is not available for patients under the age of 20 years. Reference Ranges are customized by gender and age for each patient when possible, based on data from published literature. Reference Range/Comments reported separately at the end of the report. 2 For further information about our Cardio IQ solution, please visit Education.QuestDiagnostics.com

3 The Cardio IQ Report Key Attributes (Continued) Age: 60 Fasting: Y Gender: M Collected 04/04/2014 Risk Ranges indicate three levels of risk based on data from published literature. Optimal Moderate 12/18/13 Optimal Moderate Metabolic Markers HOMOCYSTEINE, CARDIOVASCULAR umol/l 12.9 <11.4 >=11.4 % of 5.8 <= >=6.5 HEMOGLOBIN A1c total Hgb VITAMIN D, 25-OH, TOTAL ng/ml 84 >= <20 INSULIN uiu/ml 10 <23 >=23 GLUCOSE 110 > >=126 Omega 3 & 6 Fatty Acids, Plasma OMEGA 3 (EPA+DHA) INDEX EPA/ARACHIDONIC ACID Genetic Cardiovascular Markers LPA ASPIRIN GENOTYPE lle/met Heterozygous carrier: associated with elevated Lp(a) levels and CVD risk and aspirin response in some clinical studies. Trp/Arg Heterozygous carrier: associated with increased CHD risk and greater CHD KIF6 GENOTYPE event reduction with atorvastatin and pravastatin therapy in certain clinical studies. 9p21 GENOTYPE Homozygous carrier (rs and rs ). Increased 9p21 associated CVD risk. rs gg rs APO E GENOTYPE 3/3 Apo E3 Carrier. Most common (normal) genotype. LPA INTRON 25 GENOTYPE Homozygous carrier: associated with elevated Lp(a) levels and increased CVD risk. CYP2C19 GENOTYPE *2 Intermediate metabolizer. 4q25 AF RISK GENOTYPE Noncarrier: No increased 4q25 asssociated risk of atrial fibrillation or cardioembolic stroke. rs rs gg % 0.5 > < >0.8 <=0.8 Advanced cardiovascular tests are organized into functional categories for ease of interpretation: Lipid Panel Lipoprotein Subfractionation Apolipoproteins Inflammation Heart Failure Metabolic Markers Genetic Cardiovascular Markers 3

4 help improve heart health. Please talk to your provider, visit 4myheart.com or call opt 2 to learn more. Medical Information for Healthcare Providers: If you have any questions about any of the tests in our Cardio IQ offering, please call opt 3 to speak to a clinical liaison. For frequently asked questions, you can also visit us at The Cardio IQ Report Ion Mobility Detail Metabolic Markers HOMOCYSTEINE, umol/l HEMOGLOBIN A1c % of total Hgb 12.9 <11.4 >=11.4 <= >=6.5 >= <20 <23 Lipid Subclass Distributions withcardiovascular related results are displayed graphically for ease of patient education. 5.8 VITAMIN D, 25-OH, TOTAL ng/ml 84 INSULIN uiu/ml 10 GLUCOSE Patient Information 110 Specimen Information > Client Information Age: 60 Fasting: Y Gender: M Collected 04/04/2014 Patient Specimen Information Omega 3Information & 6 Fatty Acids, Plasma Age: 60 Collected: 4/04/2014 OMEGA 3 (EPA+DHA) % 0.5 Gender: M Result with Risk Category Result from INDEX Y Fasting: Opti mal 2.0 EPA/ARACHIDONIC ACID Lipid Panel The y-axis of the graph shows total lipoprotein mass. The x-axis of the graph shows HDL and LDL diameter in Angstroms (Å). Shaded areas show key clinical management metrics. The height and width of the area under the curve indicate the amount of lipoprotein particles contained within each subclass. HDL (-Density Lipids) The largest of the HDL particles is a surrogate marker for a functional cardioprotective Reverse Cholesterol Transport mechanism. The goal of treatment for CVD risk reduction is to move from a predominance of small HDL particles to large HDL particles. LDL (Low-Density Lipids) The smaller subclasses of the LDL particles are associated with increased inflammatory potential, CVD risk, and rate of atherogenic progression. The goal of treatment for CVD risk reduction is to move from smaller to larger LDL particles. Moderate 12/18/13 Client Information lle/met 81 TRIGLYCERIDES LPA ASPIRIN GENOTYPE LDL-CHOLESTEROL 89 Trp/Arg 2.7 NON-HDL CHOLESTEROL 105 Direct LDL 9p21 GENOTYPE 55 CHOL/HDLC KIF6 GENOTYPE rs Lipoprotein Subfractions gg rs LDL PARTICLE NUMBER APO E GENOTYPE LDL SMALL nmol/l nmol/l 3/3 LDL INTRON MEDIUM25 GENOTYPE nmol/l LPA HDL LARGE nmol/l CYP2C19 GENOTYPE Apolipoproteins 4q25 AF RISK GENOTYPE APOLIPOPROTEIN A1 rs APOLIPOPROTEIN B rs APOLIPOPROTEIN B/A1 LIPOPROTEIN (a) nmol/l *2 Opti mal >0.8 Moderate < mg/l LP PLA2 (PLAC ) ng/ml FIBRINOGEN ANTIGEN <=0.8 >=240 Lab: <40 EZ >=40 Heterozygous carrier: associated with elevated Lp(a) levels and CVD>=200 risk < and aspirin response in some clinical studies. < >129 Heterozygous carrier: associated with increased CHD risk and greater CHD <= >5.0 event reduction with atorvastatin and pravastatin therapy in certain clinical studies. < >159 Homozygous carrier (rs and rs ). 9p21 <100Increased associated CVD risk. > < >1538 Apo E3 Carrier. Most 300 common (normal) genotype. < >217 Homozygous carrier: associated with elevated Lp(a) levels and increased 400 < >271 CVD risk > <6996 Intermediate metabolizer. Noncarrier: No increased 4q25 asssociated risk of atrial fibrillation or cardioembolic stroke. 77 > <94 gg 80 < > < >1.30 < >= Inflammati on TREATMENT GOAL HDL HS CRP > <1.1 Risk Category Ranges LIPID SUBCLASS DETAIL FROM ION MOBILITY CHOLESTEROL, TOTAL Geneti c Cardiovascular Markers HDL CHOLESTEROL >=23 >=126 LDL TREATMENT GOAL 4.5 < < > H <=350 > Heart Failure >3.0 ProBNP pg/ml 503 <= >=900 Result Category ng/mlwith Risk Result with Risk Category46 ST2, SOLUBLE <=35 Ranges>35 Risk Category Result from Optimal Moderate OptiRanges mal Moderate Test Name Diet & Exercise Optimal Result from Risk 4myheart CoachingModerate Program: Need help achieving and maintaining an optimal weight? Managing stress?reference (O) fitness levels? (M)The 4myheart(H) Trying to improve physical program provides support and personalized lifestyle guidancerange/comments to help improvesubfracti heart health. Lipoprotein ons Please talk to your provider, visit 4myheart.com or call opt 2 to learn more. Medical Information for Healthcare If you have any questions about any of the tests inaour Cardio IQ offering, B Angstrom Providers: LDL PATTERN A please call opt 3 to speak to a clinical liaison. For frequently asked questions, you can also visit us at Angstrom > <218.2LAB: EZ Lipoprotein Subfractions on.questdiagnostics.com/faq/faq LDL PEAK SIZE LDL PATTERN Metabolic Markers A O:A M: H:B A Pattern HOMOCYSTEINE, 12.9 Risk of CVD events <11.4is based on a reanalysis >=11.4 Tertile cut-points areumol/l based on a reference range population. LDL PEAK SIZE DIABETES RISK EVALUATION O:>222.5 M: H:<218.2 > OR = Angstrom CARDIOVASCULAR (unpublished) of the data presented in Musunuru et al. ATVB 2009;29: Glucose value and assessment % of NORMAL VITAMIN D, 25-OH, TOTAL total Hgb PRE-DIABETES ng/ml 84 DIABETES INSULIN uiu/ml GLUCOSE risk for diabetes 110 Result consistent with increased 4 >=6.5 <= >= <20 <23 > >=23 >=225 >=126 HEMOGLOBIN A1c For further information about our Cardio IQ solution, please visit Education.QuestDiagnostics.com Omega & 6 Fatt Acids, Plasma HbA1c 3value andyassessment % 5.8% of total Hgb OMEGA 3 (EPA+DHA) 0.5 > <1.1

5 The Cardio IQ Report Other Detail Metrics and information needed for comprehensive personalized reporting of cardiovascular risk. Age: 60 Fasting: Y Gender: M Collected 04/04/2014 Optimal Moderate 12/18/13 Optimal Moderate OTHER DETAIL Results Results From Reference Range/Comments Metabolic Markers (continued) Lab: SLI VITAMIN D, 25-OH, D3 8 ng/ml VITAMIN D, 25-OH, D2 76 ng/ml Omega 3 & 6 Fatty Acids, Plasma (continued) OMEGA 6/OMEGA % VITAMIN D, 25-OH, D % EPA 2.2 <2.3% DHA % Foods in Omega-3* Fish Oils Nuts and Seeds Grains and Beans Salmon Walnut Walnuts Soybeans Mackerel Soybean Flax seeds Tofu Sardines Flax Pecans Swordfish Canola Bluefish Cod liver Crab Olive Cod Sardine Scallops *Adapted from March 13, 2012 Personal Factors Component Result Component Result HEIGHT FEET 5 ft SYSTOLIC BLOOD PRESSURE 140 mm Hg HEIGHT INCHES 8 in DIASTOLIC BLOOD PRESSURE 85 mm Hg WEIGHT 155 lbs TREATMENT FOR HIGH B.P. YES CALCULATED BMI 24 DIABETES NO AFRICAN AMERICAN NO PARENTAL HISTORY OF DIAB NO CURRENT SMOKER YES Any test component where clinical data do not support the Optimal, Moderate, or cut points as provided on the Result with Risk Category page will be reported in the Other Detail section of the report. A diet rich in Omega-3 fatty acids is associated with a decreased risk of cardiovascular events, including sudden cardiac death (SCD). These common food items provide a ready source of Omega-3. Patient information supplied at the time of order entry used in the calculation of the Diabetes & ASCVD Risk Evaluation Scores. 5

6 The Cardio IQ Report ASCVD Risk Evaluation A NEW expanded offering for insight into ASCVD Risk is now part of the Cardio IQ Report. Age: 60 Fasting: Y Gender: M Collected 04/04/2014 Optimal Moderate 12/18/13 Optimal Moderate The Lipid Panel/ ASCVD Risk Panel Assessment provides the 10-year and lifetime risk and 10-year goal of atherosclerotic cardiovascular disease (ASCVD) using lipid results with anthropomorphic data and family history.* 10-Year ASCVD Risk Assessment (%) Your Goal 5.7% Your Risk: 13.6% Low Risk Intermediate Risk Elevated Risk <=1% 5% 7.5% >=10% 10-year ASCVD risk categories: > or =7.5% elevated risk; 5% to <7.5% intermediate risk; and <5% lower risk. Risk estimates for an ASCVD event (nonfatal MI, CHD death, or stroke) during the next 10 years are intended for patients currently free of clinical ASCVD; Risk was estimated using the Pooled Cohort Equations: see Guidelines for ethnic group-specific considerations. [Stone et al. Circulation 2013; Goff et al. Circulation 2013] This patient-specific 10-year ASCVD risk goal is based on the patient s age, sex, ethnicity and optimal levels for other risk factors. This risk goal is calculated using the Pooled Cohort Equations. [Goff et al. Circulation 2013] Lifetime ASCVD Risk Assessment (%) Your Risk NOT CALC % Not Calc: 10-year and/or lifetime risk/goal is not calculated because the required patient risk factors have not been provided (age, sex, race, systolic blood pressure, blood pressure medication use, diabetes, and smoker status) or because a patient value is not in the range aepted by the calculator: total cholesterol ( ), HDL cholesterol ( mg/ dl), systolic blood pressure ( mm Hg), age (20-59 years, lifetime risk; years, 10-year risk). * The ASCVD risk assessment is recommended in the 2013 ACC/AHA Guidelines on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults. 1 Risk calculations are provided at no additional cost and require the following personal factors at time of order entry: Age, Gender, Race, Systolic BP, Diastolic BP, Treatment for Blood Pressure, Diabetes, Parental history of diabetes, Smoker. Reference 1. Stone NJ, Robinson J, Lichtenstein AH, Bairey Merz CN, Blum CB, Eckel RH, Goldberg AC, Gordon D, Levy D, Lloyd-Jones DM, McBride P, Schwartz JS, Shero ST, Smith SC Jr, Watson K, Wilson PWF ACC/AHA guidelines on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines This article is co-published in the Journal of the American College of Cardiology. 6 For further information about our Cardio IQ solution, please visit Education.QuestDiagnostics.com

7 The Cardio IQ Report Diabetic Risk Evaluation Age: 60 Fasting: Y Gender: M Collected 04/04/2014 Optimal Moderate 12/18/13 Optimal Moderate DIABETES RISK EVALUATION Glucose value and assessment 110 The Metabolic Markers used in the Diabetes Risk Evaluation are visually presented to facilitate patient education. NORMAL PRE-DIABETES DIABETES >=225 Result consistent with increased risk for diabetes HbA1c value and assessment 5.8% of total Hgb NORMAL PRE-DIABETES DIABETES <= >=8.0 Result consistent with increased risk for diabetes 8 Year Diabetes Risk (%) 6% <= Risk calculations are provided at no additional cost and require the following personal factors at time of order entry: Age, Gender, Race, Systolic BP, Diastolic BP, Treatment for Blood Pressure, Diabetes, Parental history of diabetes, Smoker. >=35 The risk estimate is based upon the assessment of adults ages in the Framingham study. 2 An estimate will not be provided if HbA1c and/or glucose indicate that the patient has diabetes. If fasting conditions were not met, use caution when interpreting the glucose test result and the risk estimate. Reference 2. Wilson PW, Meigs JB, Sullivan L, Fox CS, Nathan DM, D Agostino RB Sr. Prediction of incident diabetes mellitus in middle-aged adults: The Framingham Offspring Study. Arch Intern Med. 2007; 167:

8 The Cardio IQ Solution Offers a Comprehensive Approach to Heart Health Assess Baseline Risk by using advanced cardiovascular testing to help characterize a patient s individual cardiovascular disease risk. Guide Personalized Therapy by utilizing a patient s unique makeup to help determine the therapy they need to achieve better heart health. Initiate/intensify statin therapy Identify opportunities for adjunct therapy Set diet, exercise and lifestyle targets Monitor Response to Therapy against a patient s testing history to hone their treatment plan. Ongoing Patient Support through Clinical Educators helps patients understand their test results and learn how they can adopt and adhere to their clinicians treatment plan. The 4myheart Program is available at no additional cost for patients who have had testing performed. The Quest Diagnostics Clinical Educators work with patients to set goals, focus on lifestyle changes and develop treatment adherence strategies to help reduce overall cardiovascular risk. For more information, visit 4myheart.com or call (800) For more information, contact your Quest Diagnostics sales representative or visit QuestDiagnostics.com/TestCenter Notes for Advanced Cardiovasular Tests from Quest Diagnostics Aid (Order Code MI3985) a. 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. b. 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. c. 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. d. 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. e. Aspirin therapy has only been studied with low-dose (100 mg) aspirin taken orally on alternate days. f. 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. Clinical references supporting advanced cardiovascular testing may be found on the Test Descriptions and Clinical References pages of 4myheart.com. 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-aredited laboratory. These tests have not been cleared or approved by the U.S. FDA. QuestDiagnostics.com Quest, Quest Diagnostics, any associated logos, and all associated Quest Diagnostics registered or unregistered trademarks are the property of Quest Diagnostics. All third party marks and are the property of their respective owners Quest Diagnostics Incorporated. All rights reserved. MD03 09/2014

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