The NMR LipoProfile ® test may be covered 1447 York Court by one or more issued or pending patents, Burlington, NC 27215 including U.S. Patent Nos. 6,518,069; 800-788-9223 The6,576,471; NMR LipoProfile 6,653,140; ® and test 7,243,030. may be covered www.labcorp.com1447 York Court CLIA: 34D0655059 Medical Director: William F Hancock, MD Theby one NMR or moreLipoProfile issued ® or test pending may be patents, covered Burlington,1447 YNCork 27215 Court byincludingPatient one or Name U.S.more Patent issued Nos. or pending 6,518,069; patents, Gender Age Burlington,800-788-9223Page NC 27215 1 of 2 including6,576,471;SAMPLE U.S. 6,653,140;REPOR PatentT, Nos.123810 and 6,518,069;7,243,030. F 57 Account Information www.labcorp.com800-788-9223 6,576,471;CLIA: 34D0655059 6,653,140; and 7,243,030. Account # Medical Director: Williamwww.labcorp.com F Hancock, MD Physician Information Medical Director: William F Hancock, MD CLIA:Patient 34D0655059 Name Gender Age Test Account Page 1 of 2 3060 South Church Street PatientSAMPLE Name REPORT, 123810 GenderFAge 57 Account Information Page 1 of 2 Patient ID DOB Specimen ID Burlington, NC 27215 SAMPLE REPORT, 123810 F 57 Account # Account Information Physician Information Phone: (336) 436-8645 Fax: (336) 436-8645 AccountTest Account # Physician Information Date Collected Date Entered Date Reported T3060est Account SouthControl Church Number Street Fasting Patient07/17/2015 ID 07/21/2015DOB 07/21/2015Specimen 2:03ID PM 3060Burlington, South NC Church 27215 Street NO Patient ID DOB Specimen ID Burlington,Phone: (336) NC 436-8645 27215 Fax: (336) 436-8645 Phone: (336) 436-8645 Fax: (336) 436-8645 DateNMR Collected LipoProfile Date ® testEntered Date Reported ReferenceControl Range Number¹ Fasting Understanding the NMR LipoProfile®Date07/17/2015 Collected Test Report Date07/21/2015 Entered 07/21/2015Date Reported 2:03 PM Control Number FastingNO 07/17/2015 07/21/2015Percentile¹ 07/21/201520th 2:03 PM 50th 80th 95th NO LDL-P NMR LipoProfile nmoI/L® test Low ModerateReference Borderline Range¹ High Very High • LDL-P is the direct measure of low density lipoprotein NMR LipoProfile ® test ReferenceHigh Range¹ 1600 Percentile¹ < 1000 20th 1000 - 1299 50th 1300 - 1599 80th 1600 - 2000 95th > 2000 particles - the causal link between high levels of LDL-P LDL-P 20th 50th 80th 95th (LDL Particle Number) nmoI/L Percentile¹ Low Moderate Borderline High Very High and development of cardiovascular disease (CVD) is well 1. Reference population (5,362 mennmoI/L and women) not on lipid mediLowcation enrolled in the ModerateMulti-Ethnic Study of Atherosclerosis BorderlineHigh (MESA). Mora, et al.High Atherosclerosis 2007. Very High established. LDL-P 1600 < 1000 1000 - 1299 1300High - 1599 1600 - 2000 > 2000 • Studies have demonstrated per-particle cholesterol amount (LDL Particle Number) 1600 < 1000 Near1000 or - Above1299 1300Borderline - 1599 1600 - 2000 > 2000 LipidsLDL-P mg/dL Optimal High Very High varies in patients with type II diabetes, statin-treated 1.(LDL Reference Particle population Number) (5,362 men and women) not on lipid medication enrolled in the Multi-EthnicOptimal Study of AtherosclerosisHigh (MESA). Mora, et al. Atherosclerosis 2007. patients, and those with cardiometabolic risk factors (CMR) LDL-C1. Reference population (5,362 men and90 women) not on lipid medi< cation100 enrolled in the Multi-Ethnic100 - 129 Study of Atherosclerosis130 - 159 (MESA). Mora,160 et al. -Atherosclerosis 189 2007. ≥ 190 1,2,3 (calculated) listed below: Near or Above Borderline 4 Lipids mg/dL Optimal High Very High Age: men ≥45 yrs, women ≥ 55 yrs) NearOptimal or Above BorderlineHigh Lipids mg/dL Optimal High Very High Elevated BP: (≥130/≥85 mmHg; on antihypertensive LDL-C mg/dL90 < 100 100Optimal - 129mg/dL 130High - 159 160 - 189 mg/dL≥ 190 medication)5 LDL-C(calculated) 90 < 100 100 - 129 130 - 159 160 - 189 ≥ 190 (calculated)HDL-C 48 Triglycerides 78 Total Cholesterol 198 Abdominal obesity/waist circumference: MANAGINGDesirable ≥ TO40 AN LDL-P GOALDesirable CAN < 150 BE ACCOMPLISHEDDesirable < 200 male ≥ 40” (Asian ≥ 35”), female ≥ 35” (Asian ≥ 31”)5 mg/dL mg/dL mg/dL LDL-C is inaccurate if patient is non-fasting. WITHIN EXISTINGmg/dL THERAPEUTIC STRATEGIESmg/dL AND GUIDELINESmg/dL Elevated triglycerides: (≥150 mg/dL), low HDL HDL-C 48 Triglycerides 78 Total Cholesterol 198 (men < 40 mg/dL, women < 50 mg/dL), increased HistoricalHDL-C ReportingDesirable48 ≥ 40 Triglycerides Desirable78 < 150 Total Cholesterol Desirable198 < 200 2,5 numbers of small dense LDL particles, on drug LDL-C is inaccurate if patient is non-fasting. • OutcomeDesirable study data ≥ 40 has shown when measures ofDesirable < LDL-P150 and LDL-C Discordance inDesirable MESA 14< 200 treatment for elevated triglycerides or HDL-C LDL-C is inaccurate if patient is non-fasting. 5 LDL-C and LDL-P agree (concordance), risk factor Relationship with Incident CVD Events (n=319) Elevated fasting blood glucose: (≥ 100 mg/dL), on HistoricalLDL-P Reporting drug treatment for elevated glucose Historicalprofiles Reporting are favorable. However when LDL-C and 2 Insulin resistance: (IR) LDL-P disagree (discordance), CVD risk tracks with 9 ►1600 (07/17/2015) • Many expert panels recommend use of LDL-P values to LDL-P LDL-P or Apo B. optimize treatment decisions in these at-risk patients.2,6 LDL-P • Since LDL-C may be an unreliable measure in • NMR LipoProfile® Test is FDA cleared for use in conjunction ►1600 (07/17/2015) with other lipid measurements and clinical evaluation to aid patients with type II diabetes, statin-treated ►1600 (07/17/2015) in the management of lipoprotein disorders associated patients, and those with CMR factor due to 7 per-particle cholesterol variability, expert panels with CVD. LDL-C recommend use of LDL-P or Apo B to optimize treatment decisions in these patients.4,5,8,11,12,13 Lipids ►90 (07/17/2015) LDL-C • Traditional lipid panel includes LDL-C, HDL-C, triglycerides LDL-C and total cholesterol. ►90 (07/17/2015) • Whether calculated or measured directly, LDL-C is an Personalized LDL Management►90 (07/17/2015) estimate of the amount of cholesterol contained within Targets of Therapy (Adapted with permission from International Guidelines Center2) 1 This document contains private and confidential health information protected by state and © 1995-2015 Laboratory Corporation of America® Holdings LDL-P. HIGH federal law. If you have received this documentLOW in error, please call 800-222-7566. BORDERLINE All Rights Reserved - Enterprise Report Version: 1.00 LDL-P 1000 1300 This document containsranges private* and confidential health information protected by state and © 1995-2015 Laboratory Corporation of America® Holdings federal law. If you (nmol/L):have received this document in error, please call . All Rights Reserved - Enterprise Report Version: 1.00 Historical Reporting This document contains private and confidential health information protected800-222-7566 by state and © 1995-2015 Laboratory Corporation of America® Holdings Patient LDL-P and LDL-C values and dates of services are federal law. If you have received this documentTarget infor error, high–risk please callpatients 800-222-7566. Target for moderate-risk patientsAll Rights Reserved - Enterprise Report Version: 1.00 tracked over time, providing opportunities for clinician/patient LDL-C discussions regarding treatment strategies ranges* 100 130 (mg/dL): Reduce LDL Particle Production By: Improve LDL Particle Clearance By: • Diet • Exercise • Weight Loss • More potent Statins 35% to 55% LDL-P • Glycemic Control • Gut agents • Marine Omega-3 Ezetimibe - 15% to 25% LDL-P DHA + EPA - no consistent effect on LDL-P Resins/Bile Acid Sequestrants - 15% to 30% LDL-P EPA Only - 4% to 15% LDL-P • Statin + Gut, Statin + Niacin 50% to 70% LDL-P • Statin + Gut + Niacin >60% LDL-P The NMR LipoProfile ® test may be covered 1447 York Court by one or more issued or pending patents, Burlington, NC 27215 including U.S. Patent Nos. 6,518,069; 800-788-9223 6,576,471; 6,653,140; and 7,243,030. www.labcorp.com1447 York Court CLIA: 34D0655059 Medical Director: WilliamBurlington, F Hancock, NC 27215 MD 800-788-9223 Patient Name Gender Age Page 2 of 2 Medical Director: William F Hancock, MD SAMPLE REPORT, 123810 F 57 Specimen Number Patient ID Account Number AccountAccount Information Phone Account Fax Account # Physician300-001-0094-0 Information 90000999 (336) 436-8645 (336) 436-8645 Patient Last Name Patient First Name Test Account Account Address SAMPLE REPORT 123638 3060 SouthLabCorp Church Test Street Master Test Account PatientAge ID Date of Birth DOBSex SpecimenFasting ID Burlington, NC 27215 00 N/A NOT SPECIFIED 3060 South Church Street Phone: (336) 436-8645 Fax: 1447(336) York 436-8645 Court Control Number NPI Burlington, NC 27215 Burlington, NC 27215 Understanding the NMR LipoProfile®Date Collected Test Report Date Entered Date Reported Control Number Fasting Date Collected Date Entered Date and Time Reported Physician ID & Name Page Number 07/17/2015 07/21/2015 07/21/2015 2:03 PM 800-788-9223NO 10/25/2015 10/26/2015 11/13/2015 11:48 AM ET Medical Director: William 2F Hancock,of 2 MD PARTICLESpecimen CONCENTRATION Number AND SIZEPatient ID Account Number Account Phone Account Fax LDL and HDL Particles PARTICLE300-001-0094-0 CONCENTRATION AND SIZE 90000999 (336) 436-8645 (336) 436-8645 Lower CVD Risk Higher CVD Risk Patient Last Name Patient First Name Account Address • HDL-P is the direct measure of high density lipoprotein LDL and HDL Particles Lower CVD Risk Higher CVD Risk SAMPLE