Rheumatoid Arthritis Test ReportDate Presented - Feb 4, 2019

Ordering Doctor

Name: Dr. Jody SmithLicense #: 00515515UPIN #: A999Z9NPI #: 9999999999

Patient Details

Jane SmithPatient Number: 100523DOB: Jan 1, 1980Gender: Female Ph: (234) 234-2343

Specimen Details

Sent: July 2, 2019Collected: July 1, 2018Tested: July 5, 2019Source: Capillary Blood

Welcome To Your Results

We received your small volume blood sample, and tested it for the presence of certain biomarkers commonly associated with rheumatoid arthritis.

The testing platform used to produce the results described in this report has been shown to detect these biomarkers to a high level of accuracy when they are present, and to also correctly show a negative result when they are not present.

When shared with your healthcare professional, we are confident this report will provide insight to inform healthcare decisions that may improve your health and quality of life.

You and your healthcare professional can trust the science behind these results, as our lab partners have completed validation studies comparing this process to established testing methods.

For any questions about this test, please visit us at www.imaware.health or connect with us via email at support@imaware.health.

Dear Jane Smith,

In good health,The imaware team

Rheumatoid Arthritis Test - Medical Advisory Team

Dr. NeiwoldDirector of the NYU Colton Center forAutoimmunity, a leading research center.

Dr. DeaneProfessor and Researcher for Early RA Detection at University of Colorado.

The imaware™ team designs and validates each at-home test alongside world-renowed medical doctors and scientists.

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Rheumatoid Arthritis Test

Rheumatoid Arthritis Test - Your Results Summary

Jane, you are highly likely to have rheumatoid arthritisbased on biomarker sampling as well as patient specific considerations. [1-11]

CCP IgG

ELEVATED

RF IgA

ELEVATED

RF IgM

ELEVATED

A biomarker (“biological marker”) refers to a category of objective signs that indicate medical state. Elevated biomarker levels in your blood can signal the presence of a disease. We tested your blood for the following three (3) biomarkers that are associated with rheumatoid arthritis:

BIOMARKER SAMPLING

• You indicated that you have not been previously diagnosed

• You indicated that you have not been evaluated for joint pain by a doctor.

We included specific aspects of your history and condition as part of this test in order to confirm your likelihood.

PATIENT SPECIFIC CONSIDERATIONS

Your overall likelihood is compared to the possible scenarios

Your Next Steps

Less than 2% likelihood

Not Likely

Between 2-25% likelihood

Less Likely

Between 25-60% likelihood

Somewhat Likely

More than 60% likelihood

Highly Likely

Your blood sample contained elevated biomarker levels

You indicated a pre-condition that may increase your likelihood of having this condition

Your likelihood estimate is based on biomarker sampling and preconditions:

Likelihood of rheumatoid arthritis92%

Share these results with your doctor, who can review your results and provide an action plan before you make any major lifestyle changes.

If you begin to make any doctor recommended lifestyle changes related to a rheumatoid arthritis diagnosis, the imaware™ portal will provide you with helpful links and informatin to support living witth rheumatoid arthritis.

Name: Jane SmithDOB: Jan 1, 1980

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Rheumatoid Arthritis Test - Detailed Results

DETAILED PATIENT RESULTS TABLE

CCP IgG

Analyte

160 - Positive

Quantitative (U/mL) & Qualitative Result

40

Cutoff (U/mL)

83%

Sensitivity (+/-95% CI)

79%RF IgA 40 - Positive 10 76% 93%RF IgM 60 - Positive 16 92% 83%

Specificity (+/-95% CI)

The following pages provide additional information that should be shared with your healthcare professional.

Robust and Validated Clinical Performance of imaware™ Assay

The following ROC Analysis dot plots showcase range, cut-off, sensitivity, and specificity of rheumatoid arthritis positive and normal samples. Overall sensitivity and specificity are further increased through use of combined likelihood ratios. [1-11]

Name: Jane SmithDOB: Jan 1, 1980Rheumatoid Arthritis Test

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Rheumatoid Arthritis Test - Detailed Results

TEST NOTES AND LIMITATIONS

The following pages provide additional information as to how pre-existing patient conditions and risk factors are used dynamically in the rheumatoid arthritis likelihood calculations to further personalize patient results.

The patient provided the following joint pain detail regarding their fingers and wrists, which is used to adjust likelihood ratios for rheumatoid arthritis.

The patient also provided the following additional joint pain detail regarding other joints, which may be useful for the diagnosing doctor.

• These test results should be shared with your healthcare provider

• This test is not to diagnose rheumatoid arthritis - only your healthcare provider can make that determination, in light of your overall health history and the results of other testing they may decide to order

• Please consult your healthcare provider before making any lifestyle changes

• Patient sample was performed on July 5, 2019 by Trinity Lab. CLIA #33D0170905, located at 10 Earhart Drive, Suite 100, Williamsville, NY, 14221 -

Dr. Thomas Shanahan, Director of Clinical Laboratory Services.

Name: Jane SmithDOB: Jan 1, 1980

PATIENT DISEASE AND SYMPTOMS STATUS

• The Patient indicated that they have not been previously diagnosed with rheumatoid arthritis.

• The Patient indicated that they have not been evaluated for joint pain by a health provider.

• The Patient indicated that they do have a family member with rheumatoid arthritis.

• The Patient indicated that they are feeling joint pain.

• The Patient indicated that joint pain has occurred for more than 6 weeks.

• The Patient indicated that they are experiencing morning join stiffness for 60 minutes or more.

PATIENT PRE-EXISTING JOINT PAIN TABLE

Finger

Joint

Yes, as per patientYes, as per patient

Left Side (Y / N)

Yes, as per patientYes, as per patient

Right Side (Y / N)

Wrist

Elbow

Joint

Yes, as per patientYes, as per patient

Left Side (Y / N)

Yes, as per patientYes, as per patient

Right Side (Y / N)

ShoulderYes, as per patient Yes, as per patientHipYes, as per patient Yes, as per patientKneeNo, as per patient No, as per patientAnklesNo, as per patient No, as per patientToes

Rheumatoid Arthritis Test

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1. 2010 Rheumatoid arthritis classification criteria: An American College of Rheumatology/European League Against Rheumatismcollaborative initiative.2010 Rheumatoid Arthri tis Classification Criteria.

2. T.B. Niewold M.J. Harrison S.A. Paget.Anti-CCP antibody testing as a diag nostic and prognostic tool in rheumatoid arthritis.QJM: An International Journal of Medicine, Volume 100, Issue 4, 1 April 2007, Pages 193–2 01, https://doi.org/10.1093/qjmed/hcm015

3. Andreas Swart, Rufus W. Burlingame, Irmgard Gürtler, Michael Mahler, Clinica Chimica Acta.Third generation anti-citrullinated peptide antibody assay is a sensitive marker in rheumato id factor negative rheumatoidarthritis.

4. Salvatore Corrao, Luigi Calvo, Giuseppe Licata.The new criteria for classification of rheumatoi d arthritis: what we need to know for clinical practice.European Journal of Internal Medicine.

5. J. Adam Rindfeisch, M.D., and Daniel Muller, M.D., Ph.D.Diagnosis and Management of Rheumatoid Arthritis - American Family Physician.University of Wisconsin–Madison, Madison, Wisconsin.

6. Eugene Mochan, DO, PhD, Mark H. Ebell, MD, MS.Predicting Rheumatoid Arthritis Risk in Adults w ith Undifferentiated Arthritis.Am Fam Physician. 2008 May 15;77(10):1451-1453.

7. C Rakieh, J L Nam, L Hunt, E M A Hensor, S Das, L-A Bissell, E Villeneuve, D McGonagle, R Hodgson, A Grainger, R J Wakefield, P GConaghan, P Emery.Predicting the develo pment of clinical arthritis in anti-CCP positive individuals with non-specific musculoskeletal symptoms: aprospective observational cohort study.Eur J Endocrinol. 2017;176(2):133-141.

8. Anne Miller, Alison L. Nightingale, Cormac J. Sammon, Kamal R. Mahtani, Tim A. Holt, Neil J. McHugh, and Raashid A. Luqmani.Estimating the diagnostic accuracy of rheumatoid factor in UK primary care: a study using the Clinical Practice ResearchDatalink.OP-BRHE 150131 1882..1889, Rheumatology.

9. A/P Lau Tang ChingApproach to Symme trical Polyarthritis with Focus on Rheumatoid Arthritis.Updates in Rheumatology

10. Lotte Arwen van de Stadt, Birgit I Witte, Wouter H Bos, Dirkjan van Schaardenburg.A prediction rule for the development of arthritis in seropositive arthralgia patient s.Clinical and epidemiological research.

11. Penny F. Whiting, PhD; Nynke Smidt, PhD; Jonathan A.C. Sterne, PhD; Roger Harbord, MSc; Anya Burton, BSc; Margaret Burke, MSc;Rebecca Beynon, MA; Yoav Ben-Shlomo, PhD, MD; John Axford, DSc, MD; and Paul Dieppe, MD.Systematic Review: Accuracy of Anti–Citrullinated Peptide Antibodies for Diagnosing Rheuma toid Arthritis.Annals of Internal Medicine.

SCIENTIFIC REFERENCES CONTINUED

Author, Date, Article

Name: Jody SmithDOB: Jan 1, 1980Rheumatoid Arthritis Test