A Guide to Your Vectra Molecular Result · 2021. 1. 22. · Vectra Disease Activity Levels: Low: 1 to 29 Moderate: 30 to 44 High: 45 to 100 Vectra Score measures the concentrations

Vectra® is an advanced blood test that measures inflammation caused by your rheumatoid arthritis (RA), predicts your risk of developing permanent joint damage, and helps monitor disease activity and how your treatment plan is working.

Now with Vectra® Cardiovascular (CV) Risk, a personalized risk assessment that predicts your risk for a CV event in the next 3 years.

NOW WITH

A Guide to Your Vectra® Molecular Result

View Your Score at the myVectra Patient Portal

Your test results will be sent to your provider’s office. Use your Vectra test results to discuss your treatment plan and goal with your provider.

All current and future Vectra® Scores can be accessed on the patient portal, myVectra*

Create myVectra Easy Access on Your Mobile Phone

• Access all your Vectra reports

• Track your RA symptoms and see how your treatment plan is working

• Generate a personalized report of symptoms and medication after tracking in myVectra and take to your next appointment

• Chat with the Vectra Community

Go to VectraScore.com

Click the link at the top right corner

Click ‘Create an Account’

Fill out patient information form and verify email

For help or questions regarding account creation, call Customer Service: 1-877-743-8639

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Create Your Secure myVectra Patient Portal Account

*Vectra Scores will appear in myVectra™ 2-weeks after the test has been analyzed and reported

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MEDICATION LOG

DRUG DOSAGE DATE STARTED

DATE ENDED

USED AS PRESCRIBED

ALEVE®

(naproxen) 436ml 2x/day 02/03/2019 08/26/2019 YES

Notes:

AVINZA®

(morphine sulfate) 294mcg 1x/2 days 02/09/2019 01/06/2020 YES

Notes:

LORTAB®

(acetaminophen hydrocodone)

540ml 2x/day 04/16/2019 --- YES

Notes:

NAPROSYN®

(naproxen) 275mcg 1x/day 05/15/2018 --- NO

Notes:

VOLTAREN®

(diclofenac) 960ml 1x/day 02/26/2019 03/13/2019 SOMETIMES

Notes:

02/19/20 - 05/ 19/20

MYVECTRA SYMPTOM TRACKER

Date of Birth: JUN-20-1971

Phone: 000-000-0000

Total days reporting:

Total days tracked in period:

90

52

PATIENT NAME: DAYSJane Doe

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DAILY FUNCTIONALITY

Terrible

Great

Could be Better

Ok

2/19/20 5/19/204/19/203/19/20

Driving

2/19/20 5/19/204/19/203/19/20

Sleeping

2/19/20 5/19/204/19/203/19/20

Exercising

2/19/20 5/19/204/19/203/19/20

Daily Living

2/19/20 5/19/204/19/203/19/20

Ability to Work

2/19/20 5/19/204/19/203/19/20

Cooking

Terrible

Great

Could be Better

Ok

Terrible

Great

Could be Better

Ok

Terrible

Great

Could be Better

Ok

Terrible

Great

Could be Better

Ok

Terrible

Great

Could be Better

Ok

02/19/20 - 05/ 19/20



Phone: 000-000-0000



90

52


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04/19/ 19 - 04/19/20

Bigger circles = more taps over time NO PAIN MILD MODERATE SEVERE1 2 30

JOINT PAIN



Phone: 000-000-0000



203

365


73 no-pain days recorded

04/2020 - 06/20207 Pain Free Days

07/2020 - 09/2020 10/2020 - 12/202001/2020 - 03/2020No Data

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02/19/20 - 05/ 19/20

MOST RECENT VECTRA SCORE

Scor

e

0

100

25

50

75

2/1/2010/1/199/1/19 5/1/201/1/20 4/1/2012/1/19 3/1/2011/1/19

254/1/20

321/5/20

489/25/19

The Vectra score is reported on a scale of 1-100. Patients in the high and moderate categories are considered to have uncontrolled infl ammation, and may require treatment modifi cation. For your full test report visit my.vectrascore.com

Level of DiseaseActivity

Vectra Score

*As of December 4, 2017 the Vectra score is adjusted based on the age, gender, and adiposity of the patient.

LOW MODERATE HIGH

1 to 29 30 to 44 45 to 100



Phone: 000-000-0000



90

52


VECTRA SCORE - LAST 2 YEARS

Low (1-29) Moderate (30-44) High (45-100)

Vectra Score

21LOW (1-29)4/1/20

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Vectra Score

50%

40%

30%

20%

10%

0%20 40 60 80 1001

2%This Patient

RISK OF RADIOGRAPHIC PROGRESSION (RP)

The risk of RP is shown as a function of Vectra Score (see graph, right). The defi nition of RP is a 1-year total Sharp score change of >5 units. Increased risk of RP means a greater chance of irreversible joint damage.

Patient serostatus may affect the risk of radiographic progression. Thus, the actual risk of radiographic progression may be higher if this patient is seropositive and lower if this patient is seronegative.

View, Learn and Track with myVectra™

1 Visit my.VectraScore.com on your mobile internet browser app

2 Android; Chrome: tap the 3 dots in upper right hand corner

Apple; Safari: tap the “share”

button at the bottom of screen

3 Select option “Add to Home Screen”

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SAMPLE

The Vectra test is intended for clinical use. Crescendo Bioscience Inc. and Myriad Genetics, Inc. developed Vectra and determined its performance characteristics. The Crescendo Bioscience Clinical Laboratory is certifi ed under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as qualifi ed to perform high complexity clinical testing and is a College of American Pathologists Accredited Laboratory.

Laboratory Director: Bruce F Arnold, MD, FCAP Crescendo Bioscience, Inc. a Myriad Genetics Company320 Wakara Way, Salt Lake City, UT 84108VectraScore.com | F: 1-877-743-8640 | P: 1-877-743-8639

While the Vectra Score provides important objective data, it is intended for informational purposes only and does not constitute a recommendation. Medical management decisions should be made by a healthcare provider with an understanding of the full medical history and clinical assessment of the patient. For full test specifi cations and related publications, please visit VectraScore.com.

Report Sample 4.2 RP 10/19

VECTRA SCORE DESCRIPTION

Vectra Disease Activity Levels: Low: 1 to 29 Moderate: 30 to 44 High: 45 to 100

Vectra Score measures the concentrations of 12 serum proteins. An algorithm is applied to these concentrations to calculate a disease activity score on a scale of 1 to 100. The Vectra Score is personalized based on the age, gender, and adiposity of the patient.

CHANGE IN SCORE DESCRIPTION

Change in Score is assessed in relation to the Minimally Important Difference (MID) for Vectra. The MID for patients with a Moderate or High Vectra Score is 8.0.

VECTRA SCORES OVER TIME Complete score history shown on last page.

ORDERING PHYSICIAN: Physician Name, MD

RECEIVING HEALTHCARE PROVIDERClinic United Partnership Example of Oklahoma University1234 Pennsylvania Ave, Bldg 100, Ste 123, Dept of RheumatologyAnytown, OK 12345Phone: 555-555-1234 / Fax: 555-555-1234

SPECIMENCollection Date: JUL-24-2020Receipt Date: JUL-25-2020

PATIENTName: Jane DoeDate of Birth: JUN-20-1971Patient ID: 000-000-0000Gender: FemaleTRF ID: 00000000-00

REPORTReport Date: JUL-30-2020

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Vectra Score

50%

40%

30%

20%

10%

0%20 40 60 80 1001

11%This Patient

Vectra Molecular ResultVectra Score Risk of RP Change in Score Vectra Score Interpretation

1-Year Risk of Radiographic Progression

MeaningfulChange Not Calculated

Multiple Vectra ScoresRequired for Meaningful

Change Calculation

High Vectra Score: 58

Patient has a High Vectra Score and is at increased risk for radiographic progression. Consider adjusting treatment regimen to reduce infl ammation, and retesting at the next clinical visit.

58HIGH

(45-100)

11%

HighModerateLow

100

44

29

1

58

Jan, 2020Jan, 2019Jan, 2018 Jan, 2021*

01/07/21

* As of December 4, 2017 the Vectra Score is adjusted based on the age, gender and adiposity of the patient.




44

Meaningful Change (≥8 MID)

06/25/20

2711/15/19

2 3 41 Vectra Score Interpretation: Provides a more detailed explanation of your Vectra Score, your disease activity category, risk of radiographic progression and treatment plan suggestions.

Vectra Score: This is your personalized Vectra Score that measures 12 proteins found in the blood called biomarkers that have been associated with RA. The score is personalized to you by factoring in your age, gender and body fat (measured by leptin), all of which can affect levels of inflammation.1

Risk of RP: This is your risk of rapid radiographic progression (RP) over the next 1 year.

Change in Score: If this is your first Vectra test, there will be no change in score measure to provide, your report will state “Meaningful Change Not Calculated.” If you have had previous Vectra testing, the Change in Score section will indicate if there has been a meaningful change of 8 units or more, or no change, in your disease activity.

Your Vectra Molecular Result includes 3 parts

Your personalized Vectra Score is reported as a number on a scale from 1 to 100. Your Vectra Score will be color coded, based on the level of disease activity and inflammation, and will fall into low (1-29), moderate (30-44) or high (45-100).

Vectra Score

24LOW (1-29)

Vectra Score

37MODERATE

(30-44)

Vectra Score

58HIGH

(45-100)

A Vectra Score in the low category means that your RA disease activity and inflammation is low. Generally, this means your RA is being well controlled by your current treatment plan.

A Vectra Score in the moderate category means that your RA disease activity and inflammation is higher than the ideal (the low disease activity category), but is not as concerning as a score in the high disease activity category.

A Vectra Score in the high category means that your RA disease activity and inflammation is high and could suggest that your RA may not be responding to your current treatment. Vectra Scores in the high disease activity category are known to be associated with a higher risk of permanent joint damage.2

V E C T R A S C O R E1

Understand Your Result: The Vectra Score

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SAMPLE
















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Vectra Score

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40%

30%

20%

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11%This Patient





Change Calculation



58HIGH

(45-100)

11%

HighModerateLow

100

44

29

1

58

Jan, 2020Jan, 2019Jan, 2018 Jan, 2021*

01/07/21





44


06/25/20

2711/15/19

*

Inflammation can be more than painful and swollen joints. Inflammation can affect your entire body, including your organs. Vectra is an objective measure of your disease activity and inflammation that goes beyond signs and symptoms.6,7

1 in 5 patients in clinically-defined remission had progression of radiographic joint damage over 1-year3

R A D I O G R A P H I C P R O G R E S S I O N2

Radiographic Progression Chart7

The Vectra Score correlates to the risk of radiographic progression, which may lead to permanent joint damage. The higher the score the higher the risk of irreversible joint damage.

* Radiographic progression is assessed by validated Sharp score method. A change in Sharp score of >5 within a year is considered rapid RP.

Visible effects of joint damage and deterioration that may be observed on x-ray and cause permanent damage

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Vectra Score

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0%20 40 60 80 1001

11%This Patient





Change Calculation



58HIGH

(45-100)

11%

HighModerateLow

100

44

29

1

58

Jan, 2020Jan, 2019Jan, 2018 Jan, 2021*

01/07/21





44


06/25/20

2711/15/19

Understand Your Result: Radiographic Progression (RP)

Patient score decreased by 8 or more units from previous test

Patient score increased by 8 or more units from previous test

Patient score did not increase or decrease by 8 or more units

from previous test

Changes of 8 or more in high and moderate Vectra Scores represent a meaningful change in RA inflammation. An increase in score by 8 or more units indicates an increase level of inflammation, greater risk of joint damage, and may indicate a need to change your treatment. A decrease in score by 8 or more units suggests a decrease in disease activity and a lower risk of joint damage, meaning your current treatment is working.4,5

C H A N G E I N S C O R E

MeaningfulDecrease ≥8 Units

Change in Score

MeaningfulIncrease ≥8 Units

Change in Score

No MeaningfulChange of ≥8 Units

Change in Score

3

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Vectra Score

50%

40%

30%

20%

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0%20 40 60 80 1001

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Change Calculation



58HIGH

(45-100)

11%

HighModerateLow

100

44

29

1

58

Jan, 2020Jan, 2019Jan, 2018 Jan, 2021*

01/07/21





44


06/25/20

2711/15/19

Vectra Scores Over TimeThe Vectra Scores Over Time graph represents how your RA disease and inflammation are trending. Frequent testing provides greater insight to your disease state. Your initial score is considered a baseline score and will be compared to future scores to identify a meaningful change.4

If there is a change in Vectra Score of 8 or more units representing a Meaningful Change in moderate or high scores, it will be indicated in the Vectra Scores Over Time graph.

A meaningful change of ≥8 helps guide treatment decisions.4

The change in Vectra Score reflects the change in inflammation making it a useful tool to help guide medical management decisions when used over time.4

Understand Your Result: Change in Score

*

* MID: Meaningful Important Difference

• No treatment change may be needed. Talk to your doctor about retesting in 6 to 12 months, or sooner if indicated. If your score is considered low or is continuing to decrease over time (2 or more consecutive tests), your doctor may choose to reduce your current treatment.

Understanding Risk for Radiographic Progression (Permanent Joint Damage)Patients in the high and moderate categories are considered to have uncontrolled inflammation, and may require treatment modification. Vectra is the best predictor of radiographic progression and permanent joint damage. Studies have shown that the risk of radiographic progression is higher in patients with high Vectra Scores, even in cases where the CRP and ESR were low. Patients with a lower Vectra Score had less radiographic progression.2,9

• Your doctor may consider a change to your treatment if your score has not decreased by 8 units since your previous Vectra test. A change to your treatment may mean increasing your current medication or considering a new medication. Talk to your doctor about retesting in 3 months.

• If your score has decreased by 8 or more units since your previous Vectra Score, or if you have recently changed your treatment dose or your medication, your doctor may recommend that you continue with your current treatment plan. Talk to your doctor about retesting in 3 months.

• Talk to your doctor about any treatment changes if your Vectra Score has increased by 8 or more units or if there has not been a significant decrease when compared to your previous Vectra Score. A change to your treatment may mean increasing your current medication or considering a new medication. Talk to your doctor about retesting in 3 months.

• With a Vectra Score in the moderate category, it is also possible that no treatment change is needed. For example, if your score has decreased by 8 or more units since your previous Vectra Score, this would demonstrate a significant decrease in your disease activity, and your doctor may recommend that you continue with your current treatment. If you have recently changed your treatment dose or your medication, your doctor may recommend that you continue with your current treatment. Talk to your doctor about retesting in 3 months.

* The Vectra Score Interpretation provides recommended treatment guidance. Only a medical professional can make treatment decisions concerning the medical management of patients. Recommendations data is currently in study, clinical trial is ongoing.

V E C T R A S C O R E I N T E R P R E TAT I O N * 34 Regular testing is recommended in order to

accurately monitor your disease and treatment.

Patients with a high Vectra Score are at 7% to 47% risk of irreversible joint damage within the next 1-year7

Low Score (1-29) Consider…

Moderate Score (30-44) Consider…

High Score (45-100) Consider…

7-47%

4-6%

1-3%

HIGH (45-100)

VECTRA SCORE RISK OF RAPID RP

MODERATE (30-44)

LOW (1-29)

Understand Your Result: Vectra Score Interpretation

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Vectra Score

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0%20 40 60 80 1001

11%This Patient





Change Calculation



58HIGH

(45-100)

11%

HighModerateLow

100

44

29

1

58

Jan, 2020Jan, 2019Jan, 2018 Jan, 2021*

01/07/21





44


06/25/20

2711/15/19

Sample

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SAMPLE





TYPE BIOMARKER RESULT / UNITS RA RANGE† RA PERCENTILE‡

ACUTE PHASE PROTEINSSAA 1.1 ug/mL 0.29 - 85 8%

CRP 0.32 mg/L 0.19 - 92 64%

ADHESION MOLECULES VCAM-1 0.41 ug/mL 0.39 - 1.2 68%

CYTOKINE-RELATED PROTEINSIL-6 2.9 pg/mL 2.5 - 200 6%

TNF-RI 1.2 ng/mL 0.8 - 3.9 2%

GROWTH FACTORSEGF § 190 pg/mL 12 - 410 17%

VEGF-A 330 pg/mL 75 - 790 26%

HORMONESLEPTIN 10 ng/mL 1.5 - 120 18%

RESISTIN 5.7 ng/mL 3.5 - 21 51%

MATRIX METALLOPROTEINASESMMP-1 5.6 ng/mL 1.3 - 23 21%

MMP-3 17 ng/mL 7.9 - 160 10%

SKELETAL-RELATED PROTEINS YKL-40 45 ng/mL 22 - 540 3%

† These 95% reference ranges were established from 325,781 patient samples tested at Crescendo Bioscience Clinical Laboratory.§ Inversely correlated with disease activity.‡ Subject’s biomarker level relative to levels in RA patient specimens from which the RA ranges were determined.

Please note: The individual biomarker results, which are expressed to two signifi cant fi gures, are required inputs into the algorithm used to calculate the Vectra Score. Clinical interpretation of individual biomarker levels, which have different weights in the Vectra algorithm, has not been established.

Individual Biomarker Results

PATIENT: Jane Doe DOB: NOV-1-1970 PATIENT ID: 000-000-0000 GENDER: Female

Comments

COLLECTION DATE SCORE NOTES

Nov. 15, 2019 27

Jun. 25, 2020 44

Jan. 7, 2021 58

Complete Vectra Score History


Sample

Vectra Report HeaderYour information will include your Vectra patient ID number and your test ID number, also known as test requisition number (TR). This test ID will also appear on any billing information as your account number.

Monitoring your Vectra Score over time is key to understanding your disease activity and how well your inflammation is being controlled.

Individual Biomarker ResultsThe Vectra Score is calculated from the analysis of 12 biomarkers (proteins, growth factors and hormones) that have been linked to RA. Each biomarker represents a different biological pathway in RA and carries different weight in the Vectra algorithm that is used to calculate your Vectra Score. A result for each biomarker is provided in the table and the reference range for each biomarker, specific to patients with RA, is shown in the next column. These biomarker results should not be evaluated individually.

Vectra CRP concentrations may differ from those provided by other labs and cannot be used interchangeably.

Leptin as a measure of adiposity (body mass) is used in calculation of the Vectra Score.

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The Vectra Test Report

Vectra® Cardiovascular Risk

Vectra Cardiovascular Risk is a validated prognostic test that incorporates a multi-biomarker assessment of RA inflammation and predicts your risk of having a major cardiovascular (CV) event in the next 3 years.*10

FACT: Patients with RA have ~50% greater risk of experiencing a cardiovascular event than the general U.S. population and CVD is the leading cause of death in RA patients.11,12

VECTRA SCORE 3 BIOMARKERS AGE CLINICAL

HISTORY

The Vectra Cardiovascular Risk incorporates: • RA inflammation indicated by your Vectra Score and three

of its biomarkers

• Age

• Conventional risk factors, such as tobacco use and diabetes

Vectra Cardiovascular Risk places you into 1 of 4 categories - Low, Borderline, Intermediate or High: • Patients with a lower Vectra Score have a lower average

cardiovascular risk when clinical factors such as age, sex, and medical history are the same10

If your risk for cardiovascular disease (CVD) is elevated, treatment options should be discussed with your doctor and may include: • Treatment for RA inflammation and other CV risk factors

• Lifestyle changes

*Vectra Cardiovascular Risk is for patients age 40 and older with no prior history of heart attack or stroke

Understand Your Vectra® Cardiovascular Risk Report

Patients that fall into the Intermediate and High categories may benefit from evaluation and management of rheumatoid arthritis inflammation and other CV risk factors, such as controlling diabetes and hypertension.

The Vectra and Vectra Cardiovascular Risk tests are intended for clinical use. Crescendo Bioscience Inc. and Myriad Genetics, Inc. developed Vectra and determined its performance characteristics. The Crescendo Bioscience Clinical Laboratory is certifi ed under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as qualifi ed to perform high complexity clinical testing and is a College of American Pathologists Accredited Laboratory.


The Vectra Score® and Vectra Cardiovascular Risk™ are intended for informational purposes only and do not constitute a recommendation. Medical management decisions should be made by a healthcare provider with an understanding of the full medical history and clinical assessment of the patient. The clinical information displayed here was provided by a qualifi ed healthcare provider on the Test Requisition Form and other documents and was not verifi ed by Myriad. For full test specifi cations and related publications, please visit https://vectrascore.com/clinicians/vectra-tech-specs/.

PB 298 / 11-20

SAMPLE

VECTRA CARDIOVASCULAR RISK DESCRIPTION

Vectra Cardiovascular Risk is calculated using the Vectra Score, 3 of the Vectra biomarkers (leptin, MMP-3 and TNF-RI), patient age, and clinical information provided on the test requisition form. An algorithm uses these values to generate a Cardiovascular Risk Score and from it the percentage risk, which represents the likelihood of this patient having a CV event (heart attack, stroke, or CV-related death) in the next 3 years.

Vectra Cardiovascular Risk is only intended for rheumatoid arthritis patients age 40 and above with no prior history of heart attack or stroke. Vectra Cardiovascular Risk is not intended for patients using anti-IL-6R treatment, patients with a diagnosis of cancer (excluding non-melanoma skin cancer), or patients that have been hospitalized within the past 14 days.

The technical specifi cations describing the Vectra Cardiovascular Risk test development, methods, performance and risk categories can be found at https://vectrascore.com/clinicians/vectra-tech-specs/.

VECTRA CARDIOVASCULAR RISK RESULT

Cardiovascular Risk Categories: Low Risk <1.3% Borderline Risk ≥1.3% to <1.8% Intermediate Risk ≥1.8% to <5.2% High Risk ≥5.2%

Vectra Cardiovascular Risk™

PATIENT CLINICAL INFORMATION

Improved management of rheumatoid arthritis infl ammation and other CVD risk factors may reduce CV risk.

*Cardiovascular (CV) event refers to having a heart attack, stroke or CV-related death.

PATIENT: Jane Doe DOB: NOV-1-1963 PATIENT ID: 000-000-0000 REPORT DATE: JAN-1-2021

VECTRA CARDIOVASCULAR RISK INTERPRETATION

This patient’s Vectra Cardiovascular Risk Score is 4.7 and is associated with a 5.3% risk for a cardiovascular event* in the next 3-years.

CV risk of ≥1.8% suggests that evaluation and management of rheumatoid arthritis infl ammation and other CV risk factors may be benefi cial.

RESULT: This patient has a 5.3% risk for a cardiovascular event* in the next 3 years. This patient is in the high-risk category.

5.3% RISK

Age 57

Diabetes Diagnosis YES

Hypertension (High Blood Pressure) Diagnosis NO

Other Cardiovascular Disease Diagnosis^ YES

Tobacco Use (Past or Present) YES

VECTRA SCORE

56HIGH

(45-100)

^ The Test Requisition Form asked whether the patient has ever been diagnosed with: Atrial Fibrillation, Transient Cerebral Ischemia or TIA, Peripheral Artery Disease or Atherosclerosis, Heart Failure, Coronary Artery Disease [including Angina Pectoris or other forms of Ischemic Heart Disease, Aortic Aneurysm or Dissection, Nontraumatic Intracranial Hemorrhage [not leading to stroke]

Sample

Cardiovascular Risk PercentageVectra CV Risk informs you of your risk of having a cardiovascular event (e.g., heart attack or stroke) in the next 3 years

Cardiovascular Risk CategoriesYour cardiovascular risk percentage is associated with a cardiovascular risk category. There are 4 categories: Low <1.3%, Borderline ≥1.3 to <1.8%, Intermediate ≥1.8% to <5.2% and High ≥5.2%

Patient Clinical InformationThis section captures the information that was used to calculate your Vectra CV Risk result. Your Vectra Score, age and clinical history such as high blood pressure, diabetes and tobacco use were used to create the risk percentage.

Vectra ScoreThe Vectra Score, your personalized measurement of RA inflammation

VectraScore.com | VectraCV.comYour online resource to learn more, hear patient stories

and link to additional patient information

Patient Medical Support

If you encounter any financial hardship, we will work directly with you toward your complete satisfaction. If you have any questions regarding the cost of testing, please contact Myriad.

• VectraScore.com/affordability/

• [email protected]

• 1-877-743-8639 x2

A team of highly-trained medical liaisons are available by phone or email to help answer questions regarding Vectra results.

• 1-877-743-8639 x1984

• [email protected]

Vectra Customer Service 877-743-8639 and [email protected]

Patient blog and newsletter

• Go to VectraScore.com

• General information about living with RA

• On the right sidebar prompt click newsletter icon to Signup for VectraVoice newsletter

Find out more at

Vectra® and CreakyJoints® Are Working Together to Improve the Lives of Rheumatoid Arthritis Patients

CreakyJoints is a 20-year-old non-profit digital community for millions of arthritis patients and caregivers worldwide who seek:

• Education • Support • Advocacy • Patient-centered research

CreakyJoints.org/vectra

Patient Support & Resources

Vectra should be used in conjunction with your doctor’s assessment and your self-assessment. It is important to factor in all three assessments, even when they do not agree. Track your symptoms with myVectra™ to provide your doctor with a comprehensive summary of your disease symptoms.13

Disease Management is a Shared Effort

Patient Assessment

Physician Assessment

Molecular Assessment

Molecular assessment of 12 biomarkers

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Myriad provides free aids and services to people with disabilities to communicate effectively with us, such as TTY/TDD calls or written information in suitable formats. Myriad will also provide free language services to people whose primary language is not English through qualified interpreters.

If you need these services, contact Ms. Christy Garcia:

Christy Garcia Compliance Director 320 Wakara Way Salt Lake City, UT 84108 Telephone: (513) 701-0804 Fax: (513) 440-1781 Email: [email protected]

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4. Myriad will conduct an investigation of the complaint. This investigation may be informal, but it will be thorough, affording all interested persons an opportunity to submit evidence relevant to the complaint. Myriad will maintain the files and records relating to such grievances pursuant to its document retention policies. To the extent possible, and in accordance with applicable law, Myriad will take appropriate steps to preserve the confidentiality of files and records relating to grievances and will share them only with those who have a need to know.

5. Myriad will issue a written decision on the grievance, based on a preponderance of the evidence, no later than 30 days after its filing, including a notice to the complainant of their right to pursue further administrative or legal remedies.

6. The person filing the grievance may appeal Myriad’s decision in writing to the President of Myriad within 15 days of receiving Myriad’s initial decision. The President will issue a written decision in response to the appeal no later than 30 days after its filing.

7. Individuals seeking access to Section 1557 and its implementing regulations may be facilitated by contacting Ms. Garcia (see contact information above).

8. The availability and use of this grievance procedure does not prevent a person from pursuing other legal or administrative remedies, including filing a complaint of discrimination on the basis of race, color, national origin, sex, age or disability in court or with the U.S. Department of Health and Human Services, Office for Civil Rights. A person can file a complaint of discrimination electronically through the Office for Civil Rights Complaint Portal, which is available at: https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

U.S. Department of Health and Human Services200 Independence Avenue, SWRoom 509F, HHH BuildingWashington, D.C. 20201

9. Complaint forms are available at: http://www.hhs.gov/ocr/office/file/index.html. Such complaints must be filed within 180 days of the date of the alleged discrimination. Myriad will make appropriate arrangements to ensure that individuals with disabilities and individuals with limited English proficiency are provided auxiliary aids and services or language assistance services, respectively, if needed to participate in this grievance process. Ms. Garcia will be responsible for such arrangements.

Español (Spanish)Myriad cumple con las leyes federales de derechos civiles aplicables y no discrimina por motivos de raza, color, nacionalidad, edad, discapacidad o sexo. ATENCIÓN: si habla español, tiene a su disposición servicios gratuitos de asistencia lingüística. Llame al 1-513-701-0804.

繁體中文 (Chinese)Myriad. 遵守適用的聯邦民權法律規定，不因種族、膚色、民族血統、年齡、殘障或性別而歧視任何人。注意：如果您使用繁體中文，您可以免費獲得語言援助服務。請致電 1-513-701-0804。

Tiếng Việt (Vietnamese)Myriad tuân thủ luật dân quyền hiện hành của Liên bang và không phân biệt đối xử dựa trên chủng tộc, màu da, nguồn gốc quốc gia, độ tuổi, khuyết tật, hoặc giới tính.CHÚ Ý: Nếu bạn nói Tiếng Việt, có các dịch vụ hỗ trợ ngôn ngữ miễn phí dành cho bạn. Gọi số 1-513-701-0804.

한국어 (Korean)Myriad 은(는) 관련 연방 공민권법을 준수하며 인종, 피부색, 출신 국가, 연령, 장애 또는 성별을 이유로 차별하지 않습니다.주의: 한국어를 사용하시는 경우, 언어 지원 서비스를 무료로 이용하실 수 있습니다. 1-513-701-0804. 번으로 전화해 주십시오.

Tagalog (Tagalog – Filipino)Sumusunod ang Myriad sa mga naaangkop na Pederal na batas sa karapatang sibil at hindi nandidiskrimina batay sa lahi, kulay, bansang pinagmulan, edad, kapansanan o kasarian. PAUNAWA: Kung nagsasalita ka ng Tagalog, maaari kang gumamit ng mga serbisyo ng tulong sa wika nang walang bayad. Tumawag sa 1-513-701-0804.

Русский (Russian)Myriad соблюдает применимое федеральное законодательство в области гражданских прав и не допускает дискриминации по признакам расы, цвета кожи, национальной принадлежности, возраста, инвалидности или пола. ВНИМАНИЕ: Если вы говорите на русском языке, то вам доступны бесплатные услуги перевода. Звоните 1-513-701-0804.

(Arabic) ةيبرعلا

Kreyòl Ayisyen (French Creole)Myriad konfòm ak lwa sou dwa sivil Federal ki aplikab yo e li pa fè diskriminasyon sou baz ras, koulè, peyi orijin, laj, enfimite oswa sèks. ATANSYON: Si w pale Kreyòl Ayisyen, gen sèvis èd pou lang ki disponib gratis pou ou. Rele 1-513-701-0804.

Français (French)Myriad respecte les lois fédérales en vigueur relatives aux droits civiques et ne pratique aucune discrimination basée sur la race, la couleur de peau, l’origine nationale, l’âge, le sexe ou un handicap. ATTENTION: Si vous parlez français, des services d’aide linguistique vous sont proposés gratuitement. Appelez le 1-513-701-0804.

Português (Portuguese)Myriad cumpre as leis de direitos civis federais aplicáveis e não exerce discriminação com base na raça, cor, nacionalidade, idade, deficiência ou sexo.ATENÇÃO: Se fala português, encontram-se disponíveis serviços linguísticos, grátis. Ligue para 1-513-701-0804.

Italiano (Italian)Myriad è conforme a tutte le leggi federali vigenti in materia di diritti civili e non pone in essere discriminazioni sulla base di razza, colore, origine nazionale, età, disabilità o sesso. ATTENZIONE: In caso la lingua parlata sia l’italiano, sono disponibili servizi di assistenza linguistica gratuiti. Chiamare il numero 1-513-701-0804.

Deutsch (German)Myriad erfüllt geltenden bundesstaatliche Menschenrechtsgesetze und lehnt jegliche Diskriminierung aufgrund von Rasse, Hautfarbe, Herkunft, Alter, Behinderung oder Geschlecht ab. ACHTUNG: Wenn Sie Deutsch sprechen, stehen Ihnen kostenlos sprachliche Hilfsdienstleistungen zur Verfügung. Rufnummer: 1-513-701-0804.

Polski (Polish)Myriad postępuje zgodnie z obowiązującymi federalnymi prawami obywatelskimi i nie dopuszcza się dyskryminacji ze względu na rasę, kolor skóry, pochodzenie, wiek, niepełnosprawność bądź płeć.UWAGA: Jeżeli mówisz po polsku, możesz skorzystać z bezpłatnej pomocy językowej. Zadzwoń pod numer 1-513-701-0804.

日本語 (Japanese)Myriad は適用される連邦公民権法を遵守し、人種、肌の色、出身国、年齢、障害または性別に基づく差別をいたしません。注意事項：日本語を話される場合、無料の言語支援をご利用いただけます。1-513-701-0804.

(Farsi) یسراف

1-513-701-0804

1-513-701-0804

VectraScore.com | VectraCV.com | 1-877-743-8639©2021 Myriad Genetics, Inc. All rights reserved. Myriad, Vectra, myVectra and the associated logos are trademarks or registered trademarks of Myriad Genetics, Inc. and its affiliates in the United States and other jurisdictions.

References: 1. Curtis, JR, et al., Rheumatology (Oxford). 2019 May 1;58(5):874-883. doi: 10.1093/rheumatology/key367. 2. Hambardzumyan K, et al. Ann Rheum Dis 2014;0;1-8. doi:10.1136/annrheumdis-2013-204986. 3. Brown AK, et al. Arthritis Rheum. 2008;58(10):2958-2967; Hambardzumyan K, et al. Ann Rheum Dis. 2014; doi:10.1136/annrheumdis-2013-204986. ML-ST-01AL Rev N 03/15 unauthorized changes not permitted 4. Chernoff, D. February 2019. Determination of the Minimally Important Difference (MID) in Multi-biomarker Disease Activity (MBDA) Test Scores. Clinical Rheumatology. 5. Curtis JR, et al. November 2018. Uptake and Clinical Utility of the Multi-Biomarker Disease Activity Testing in the U.S. The Journal of Rheumatology. 6. Centers for Disease Control and Prevention. Rheumatoid Arthritis. www.cdc.gov/arthritis/basics/rheumatoidarthritis.html. Accessed 2/15/19. 7. Huizinga T, et al. Predicting Risk of Radiographic Progression for Patients with Rheumatoid Arthritis [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/predicting-risk-of-radio-graphic-progression-for-patients-with-rheumatoid-arthritis/. Accessed May 29, 2020. 8. SHS, van der Heijde modified Sharp score. All patient N=235. MTX-IR n=133. Data on file. Crescendo Bioscience. 9. Wanying Li, et al. Rheumatology, Volume 55, Issue 2, February 2016, Pages 357–366, https://doi.org/10.1093/rheumatology/kev341. 10. Curtis JR, Fenglong X, Crowson CS, et al. Derivation and internal validation of a multi-biomarker-based cardiovascular disease risk prediction score for rheumatoid arthritis patients.Arthritis Research & Therapy. Pending publication. 11. Aviña-Zubieta JA, Choi HK, Sadatsafavi M, Etminan M, Esdaile JM, Lacaille D. Risk of cardiovascular mortality in patients with rheumatoid arthritis: a meta-analysis of observational studies. Arthritis Rheum. 12. Chodara AM, Wattiaux A, Bartels CM. Managing Cardiovascular Disease Risk in Rheumatoid Arthritis: Clinical Updates and Three Strategic Approaches. Curr Rheumatol Rep. 2017;19(4):16. doi:10.1007/s11926-017-0643-y. 13. Data on File. Pfizer Inc, New York, NY. RA NarRAtive Patient Survey 2016.

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Access your Vectra results and log symptoms with the myVectra Patient Portal accessible at VectraScore.com

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Documents

A Guide to Your Vectra Molecular Result · 2021. 1. 22. · Vectra Disease Activity Levels: Low: 1 to 29 Moderate: 30 to 44 High: 45 to 100 Vectra Score measures the concentrations