Lipoprotein Particle Profile™

© 2010 SpectraCell Laboratories, Inc. All rights reserved. DOC XXX 09.10

Visit us at www.spectracell.com or call us at 800.227.LABS (5227)

Lipoprotein Particle Profile™

50% of people at risk for HEART DISEASE are not identified by routine testing.

Why is LPP™ Testing The Most Comprehensive Risk Assessment?

u Provides much more accurate cardiovascular risk assessment and treatment guidelines than conventional cholesterol testing

u Detects all new NCEP risk factors, including Lp(a), RLP, HDL2b and small, dense LDLu Accurately measures the lipoprotein subgroups of VLDL, LDL and HDLu Helps identify the 50% of patients that are at risk for cardiovascular disease but have “normal” cholesterol levels

Measures Particle Density & Number

u Directly measures lipoprotein particles – both number and density (which directly correlates to size)u Takes into account cholesterol-depleted and cholesterol-enriched patients which can mislead risk assessmentu Enables clinician to treat atherogenic lipoprotein profiles before overt dyslipidemia becomes apparent

Superior Technology

u Separates lipoproteins by analytical ultracentrifugation, which is considered the CDC gold standardu Counts lipoprotein particles using proprietary technologyu Uses a continuous gradient through the entire lipoprotein density rangeu Low end of gradient is 1.000 g/ml for accurate VLDL resultsu Separation by analytical ultracentrifugation at 120,000 rpm

Additional Risk Factor Measurements

u Independent chemical assay of Lp(a)u Gives clinician overall cardiovascular lipoprotein particle profile with subgroups

and inflammation risk assessment

Easy-To-Understand Reporting

u Lists all lipid-related metabolic syndrome traitsu Graphical results are included with every reportu Clinical suggestions with treatment recommendations on each reportu Cumulative reporting available

Easy Sample Collection

u Complete test kit and transportation providedu Small sample size (less than 4 mL serum)u Quick turnaround (less than one week)u LPP™ is very cost effective and is covered by most insurances and medicare.

The LPP™ test from SpectraCell Laboratories provides physicians with the actual LDL particle count, allowing healthcare providers to accurately determine and diagnose cardiovascular risk in their practice.

(normal) (depleted) (enriched) (depleted)

Each patient shown below has the same LDL cholesterol of 125 mg/dl, but particles differ.

PLAQUE RUPTURES DUE TO

INFLAMMATION

Lp(a) RLP

HDL2b

HDL3

Foam Cells Build Plaque

Foam Cell

LDL

DENSE LDL

OXIDIZED LDL MACROPHAGE CELL

ARTERIAL INTIMA

ARTERIAL LUMEN

MONOCYTE CELL

DAMAGED

CELL

ENDOTHELIUM

423

5

1

Atherosclerotic Plaque FormationSpectraCell’s Lipoprotein Particle Profile™ (LPP™) identifies all the National Cholesterol Education Program’s (NCEP) Lipoprotein Risk Factors.

1 Small, Dense LDLis three times more atherogenic than buoyant LDL due to the additional number of LDL particles per cholesterol equivalent and the rapid penetration of small LDL particles through the arterial endothelium.

4 HDL Removes Excess LipidsHDL2b is formed from HDL3 as it removes excess lipids. High HDL2b is an indicator of functional reverse cholesterol transport.

5 LDL Oxidationis when LDL is oxidized in the intima of the vessel wall and is scavenged by macrophage cells to form foam cells. The foam cells are the building blocks of plaque. Antioxidants, measured by Spectrox®, can retard LDL oxidation.

2 RLP (Remnant Lipoprotein)is readily scavenged by macrophage cells without having to be oxidized (like other LDL) and becomes a major component of plaque.

3 Lp(a)are small, dense LDL’s and that are easily oxidized. Lp(a) is prothrombotic in many of the genetic variations.

SAMPLE

LPP™ Sample Test Report - Page 1

© 2011 SpectraCell Laboratories, Inc. All rights reserved. LPP DOC 418

Clinical Interpretation Guide to the LPPTM Test Step1.PrimaryRiskAssessment

• Lipoprotein non-HDL particle numbers and other lipid and non-lipid risk factors may show a greater patient risk than a

standard lipid panel and therefore, a greater LDL reduction than indicated by a standard lipid panel. Non-HDL lipoprotein

particle numbers and/or Apo B-100 are measures of the number of atherogenic lipoprotein particles and are compliant

with the recent consensus statement from the American Diabetes Association and the American College of Cardiology1

stating that lipoprotein particle numbers are more predictive of CVD risk than cholesterol.

• Moderate to elevated triglycerides can cause the lipoproteins to be cholesterol depleted or triglyceride enriched and these

patients will show a greater CVD risk from non-HDL particle numbers or Apo B-100 than from a standard lipid panel.

This occurs in about 30% of the population.

Step2.ModifyRiskUsingMetabolicSyndromeTraits,Lp(a)andInflammationRiskMarkers

• Evaluate possible Metabolic Syndrome by combining the lipid traits from the LPPTM test with possible hypertension, obesity

and high glucose. Three total traits is a diagnosis of Metabolic Syndrome and raises the CVD risk to the next level. Also

check for insulin resistance using the LPP™ fasting insulin value.

• Take into account additional risk from elevated Lp(a) or inflammation markers such as hs-CRP or Lp-PLA2 if ordered,

in determining the final treatment goals. Also consider non-lipid risk factors such as hypertension, obesity, high glucose,

smoking, family history and other medical history.

• The risk assessment and treatment goal from Step1 should be adjusted in light of the presence of these additional

Biomarkers and Risk Factors.

• A standard directly measured cholesterol LipidPanel is presented at the bottom of the report for comparison to

previously determined lipid results.

Step3.DetermineTherapeuticApproachBasedOntheLipidSubgroupDistribution, Lp(a)andTherapeuticGuidelines

• Using the risk level established in Step2 and treatment goals from the NCEP guidelines, determine if VLDL, LDL

subgroups, HDL subgroups and/or Lp(a) should be therapeutic targets.

• The LPP™ particle numbers by subgroup and Lp(a) each have a specific therapeutic approach that is most effective.

Often, combination therapy is needed to address the different risk areas.

• A special HDL species enriched in Apo C-1 is atherogenic but displays health attributes2. It is generally identified by high

HDL>70mg/dL, high HDL 2b > 4000 nmol/L with a high HDL peak or hump extending into LDL IV region and low

TG’s < 70 mg/dL. Check for CVD development with a CIMT, a Coronary Calcium Score or other method to confirm.

• Refer to the LPP™TherapeuticGuidelines for lipoprotein subgroup specific information.

1. Diabetes Care, Volume 31, Number 4, April 20082. Kwiterovich P., et al. JAMA 2005; 293(15): 1891

Clinical Interpretation Guide to the LPP™ Test

SAMPLE

LPP™ Sample Test Report - Page 2

Lipoprotein Particle Profile™ Testing

Copyright © 2008 SpectraCell Laboratories DOC 406-12.08ADVANCED CLINICAL TESTING

Visit us at www.spectracell.com or call us at 800.227.LABS (5227)

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LipoproteinAbnormality

LifestyleChanges

(diet & exercise) Statins Niacin FibratesOral

Estrogens ResinsAbsorptionInhibitors

Omega-3’sEPA & DHA

Alcohol(moderate)

LDL I & IIBuoyant

LDL III - Dense

HDL 2b - Buoyant

Therapeutic Beneficial Little or No Effect Negative Effect

Copyright © 2008 SpectraCell Laboratories DOC 406-12.08ADVANCED CLINICAL TESTING

Visit us at www.spectracell.com or call us at 800.227.LABS (5227)