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Contractor: Exosome Diagnostics, Inc. 266 Second Ave, Suite 200 Waltham, MA 02451 844-396-7663 Phone 617-649-4308 Fax www.exosomedx.comContract Number: 36F79720D0097 Contract Period: 3/15/2020 – 3/14/2025

Other than small businessDUNS: 827582110


Customer information

1a. Awarded Special Item Numbers: 621-200 Anatomic Pathology2. Maximum Order: $100,0003. Minimum Order: One test4. Geographic Coverage: All 48 contiguous U.S. states, Washington D.C.,

Alaska, Hawaii, and, Puerto Rico5. Point of Production: Testing Site Location:

Exosome Diagnostics, Inc. 266 Second Ave, Suite 200 Waltham, MA 02451

6. Prices herein are net, discount deducted.7. Quantity Discounts: None8. Prompt Payment Terms: Net 30 days9. Government purchase cards are accepted below and above

the micro-purchase threshold.10. Foreign Items: N/A11a. Delivery Time: 2 days for routine tests and 3-5 days for complex tests

Maximum Turn Around Time (TAT): 5 Days ARO

Assay Schedule: Hours of operation (Eastern Time):

Sunday Monday Tuesday Wednesday Thursday Friday Saturday

N/A 9 a.m. – 5 p.m. 9 a.m. – 5 p.m. 9 a.m. – 5 p.m. 9 a.m. – 5 p.m. 9 a.m. – 5 p.m. N/A

Holidays: Exosome Diagnostics is closed for the following: New Year’s Day President's Day Patriot's Day Memorial Day Independence Day Labor Day Thanksgiving (Thursday and Friday) Christmas (December 25)

11b. Expedited: No charge for emergency STAT services12. F.O.B. Points: FOB Destination to the 50 U.S. states, Washington D.C., and Puerto Rico13a. Ordering Address: Exosome Diagnostics, Inc.

266 Second Ave, Suite 200 Waltham, MA 02451


13b. Ordering Procedures:

1. Request ExoDx Prostate test kits from Exosome Diagnostics2. Place ice packs in freezer upon arrival3. Complete test requisition form (TRF)4. Utilize collection device included in package along with kit5. Notify FedEx for pickup (return with ice packs)

*See below for more detailed instruction

Contact Deborah Windsor for pricing questions, to order ExosomeDx kits, and for general questions.

[email protected] 470-902-6528

14. Payment Address: Exosome Diagnostics, Inc. 266 Second Ave, Suite 200 Waltham, MA 02451

15. Warranty/Exchange Goods: N/A16. Export Packing Charges: N/A17. Terms and conditions of Government Purchase Card acceptance: Credit cards accepted below, equal to, and above MPT.18. Terms and conditions of rental, maintenance and repair: N/A19. Terms and conditions of installation/training: N/A20. Terms and conditions of repair parts indicated, date of parts price lists

and any discounts from list prices: N/A20a. Terms and conditions of other services:

1. Test results via FAX 2. Test results via website login 3. Test results via FedEx (a hard copy of the results is mailed to the client address)

21. List of service and distribution points: N/A22. List of participating dealers: N/A23. Preventive maintenance: N/A24a. Special attributes: N/A24b. Section 508 EIT supplies and services: N/A25. DUNS Number: 82758211026. System for Award Management: Yes, registered.


SIN#Test order code

Test description

Tests included

CPT code UOI

All- inclusive FSS price with IFF

621-200 ExoDx™ Prostate (Intelliscore)

" ExoDx™ Prostate Test” (Intelliscore) is a non-DRE urine-based liquid biopsy test indicated for men 50 years of age and older with a PSA 2 – 10 ng/mL being considered for an initial prostate biopsy. A patient-specific risk score is calculated based on a proprietary algorithm that combines the weighted expression of a three-gene signature in exosomal RNA. A score above the cut point is associated with an increased likelihood of GS ≥ 7 PCa on subsequent biopsy. Physicians can utilize the result in conjunction with other standard of care prognostic information to determine whether to proceed with a tissue biopsy."

Single test 0005U EA $751.52

FSS price list

In the ExoDx Prostate Test collection kit: Collection mailer with Fedex label

Test requistion form Barcoded stickers

Urine collection device Cold packs

Biohazard bag Absorbent sheet

This test was evaluated and its performance characteristics determined by Exosome Diagnostics, Inc. Exosome Diagnostics is certified under the Clinical Laboratory Improvement Amendments (CLIA) Act of 1988 as qualified to perform high-complexity clinical testing. CLIA number: 22D2093470

Exosome Diagnostics and ExoDx are registered U.S. trademarks of Exosome Diagnostics, Inc.

MKT 127_10_2019

Questions? Please contact our customer service representatives at 844-EXOSOME (844-396-7663), Monday to Friday 9:00 a.m. to 5:00 p.m. EDT.

STEP

4Place sample inside biohazard bag with the absorbent sheet. Place test requisition form and demographics or face sheet in the outer pouch.

STEP

5Place biohazard bag in collection mailer with two (frozen) cold packs. Peel the backing from the sealing strip on the box flap and seal the mailer. Notify FedEx for pickup.

BIOHAZARD

AP E

CIIC

BIOHAZARD

SEALING STRIP

STEP

1 Complete test requisition form and fill in patient name and date of birth on the label. Print demographics or attach face sheet.

STEP

2Set up urine collection device as shown, and collect sample.

STEP

3Unscrew collection tube from funnel, close with provided lid and attach barcodes to tube and form.

Test Requisition Form

SPECIMEN INFORMATION

SITE INFORMATION

PATIENT INFORMATION

CLINICAL INFORMATION

ExoDx™ Prostate (Intelliscore) is a non-DRE urine-based liquid biopsy test indicated for men 50 years of age and older

with a PSA 2 – 10 ng/mL being considered for an ini�al prostate biopsy. For this popula�on, the test returns a risk score

that predicts the presence of high-grade (Gleason score ≥7) prostate cancer. The cut-off values for other popula�ons,

for instance men less than 50 years of age or with previous biopsies, are unknown.

Test Requisition Form

SPECIMEN INFORMATION

SITE INFORMATION

PATIENT INFORMATION

CLINICAL INFORMATION

ExoDx™ Prostate (Intelliscore) is a non-DRE urine-based liquid biopsy test indicated for men 50 years of age and older

with a PSA 2 – 10 ng/mL being considered for an ini�al prostate biopsy. For this popula�on, the test returns a risk score

that predicts the presence of high-grade (Gleason score ≥7) prostate cancer. The cut-off values for other popula�ons,

for instance men less than 50 years of age or with previous biopsies, are unknown.

Note: Patient must start and finish voidin the device.

Important office instructions ∙ When kits arrive, make sure to remove the ice packs and freeze immediately for at least 12 hours.

∙ Sample must be refrigerated within one hour of collection, and can be kept refrigerated for up to seven days.

∙ Demographics or face sheet may be included with the test requisition form.

∙ All information on the test requisition form must be completed. HCP signature is required.

∙ Patient should urinate with a full bladder (when a patient has already given a sample, he should wait at least one hour before giving another).

∙ Sample should be collected when patient first presents for his appointment, or at a followed-up scheduled appointment if a urine sample has already been provided.

DRE

Urine collection instructions for patients with an elevated PSA (PSA 2-10ng/ml)

ExoDx™ Prostate IntelliScore (EPI)A simple urine test for risk assessment of high-grade prostate cancer (HGPCa)

FOR USE IN MEN WHO:

• Have PSA 2-10 ng/mL (Gray Zone)• Are considering an initial or repeat biopsy• Are age 50 and above

Introducing the first and only exosomal molecular test that relies on genomic information

to provide risk assessment for HGPCa.

The EPI Test was developed to assist physicians to reduce unnecessary biopsies,* and can be used as a risk assessment tool to complement standard of care

features in the biopsy decision process.

EPI at a glance

Who’s the test for?

Men 50 years of age or older

Considering an initial or prior negative biopsy

PSA levels of 2–10 ng/mL

How does it work? Non-DRE

urine sampleExtraction of exosomal RNA

Gene signature of exosomal RNA

ERG PCA3 RT-qPCR SPDEF

What does the test score mean? 0 EPI below cut point:

Low risk or benign

Clinical decision: Potentially avoid biopsy,

continued monitoring

100

Cut point15.6

EPI above cut point:Higher risk

Clinical decision: Proceed to biopsy

EPI score is based on a value of 0 to 100, with the cut point at 15.6

The 2019 NCCN guidelines include the ExoDx Prostate test (EPI) for early detection in men for both initial and prior negative biopsy.*

*The test was developed as a rule-out test (91.3% negative predictive value and 92% sensitivity in the initial biopsy cohort).

EPI at a glance

EPI score

Prostate cancer is the second leading cause of cancer in men, with over 1 million new cases and 300,000 deaths.¹

The unmet clinical need in prostate cancer. Although Prostate Specific Antigen (PSA) screening is part of standard of care (SOC), its benefits have caused debate in recent years. The United States Preventive Services Task Force (USPSTF) changed its guidelines in 2018, advising men 55–69 years to make an informed choice and discuss with their doctor whether PSA screening is right for them, while recommending against screening for men over 70 years of age.² This change in guidance came about after a review of published data of 1.9 million men on the use of PSA testing to screen for cancer, based on the potential harms and benefits for PSA screening.

Limitations of PSA might include:

• Low sensitivity and specificity for prostate cancer

• PSA levels can be increased by benign prostatic enlargement (BPH) and prostatic inflammation or lower urinary tract infection

• When PSA results are in the “gray zone”, other factors such as age, family history, ethnicity and digital rectal examination (DRE) factor into the shared decision-making discussion regarding prostatic biopsy

• PSA cannot distinguish high-grade from low-grade cancer and is not prostate cancer-specific

Importantly, increased detection of prostate cancer has led to potentially unnecessary biopsies and overtreatment. The EPI Test allows for greater confidence to identify high-grade prostate cancer (GS7 and above) in patients.

Tested in >70,000 patients

Cut point prospectively validated in 1,022 men

Test algorithm independent of PSA and SOC

Complementary tool to clinical information

Publications in top-tier peer-reviewed journals: JAMA Oncology, European Urology and Prostate Cancer and Prostatic Diseases

Simple urine test that can be collected any time of the day

No DRE required prior to testing

New! At-Home Collection Kit available for use in the comfort of home. Nearly 1,000 urologists have taken advantage of this convenient option for their patients

The ExoDx™ Prostate Test The right patient, the right intervention, at the right time

When there is uncertainty about proceeding with a biopsy, The EPI Test may be a solution. Clinical studies show The EPI Test can help

avoid 27% of unnecessary biopsies⁴ in patients with PSA levels in the gray zone (2–10 ng/mL). EPI results can be part of your best practices to send

the right patient to the right intervention at the right time.

Clinical utility data

Title: Clinical utility of the exosome based ExoDx Prostate (IntelliScore) EPI test in men presenting for initial biopsy with a PSA 2–10 ng/mL (Tutrone et al, May 2020, Prostate Cancer and Prostatic Diseases).

Study design: The ExoDx Prostate Test was studied in a real-world clinical setting that included 72 urologists, 24 sites and more than 1,000 patients. The study is the first-ever prospective, multi-center, randomized prostate biomarker trial with a blinded control arm conducted in a clinical utility setting.

Key findings: When implementing the ExoDx Prostate Test in a real-world clinical setting, patients demonstrated improved compliance with the physician’s recommendation to defer prostate biopsy when the test score was below the cut point of 15.6, and proceed to biopsy when the test score was above 15.6.³

of patients complied to physician recommendation to defer biopsy due to The EPI Test based on the physician-patient shared decision

92%

of patients complied to physician recommendation to proceed to biopsy due to The EPI Test based on the physician-patient shared decision making, compared to only 39% in the SOC control arm

72%

more cases of clinically significant or high-grade prostate cancer were detected by physicians due to increased compliance, compared to the standard of care control arm

30%

Urologists use the EPI score in a real-world clinical setting to inform the right intervention, with the right patient, at the right time.

EPI100% (N=458)

Urologist’s recommendation 20% (N=93)

Biopsy37% (N=34)

Deferral63% (N=59)

Bx37%

(N=34)

No Bx44%

(N=15)

Biopsy performed26% (N=24)

Bx8%

(N=5)

No Bx92%

(N=54)

Biopsy deferred74% (N=69)

Urologist’s recommendation 80% (N=365)

Biopsy87% (N=318)

Deferral13% (N=47)

Bx72%

(N=229)

No Bx28%

(N=89)

Biopsy performed66% (N=240)

Bx23%

(N=11)

No Bx77%

(N=36)

Biopsy deferred34% (N=125)

<15.6 ≥15.6Low risk by EPI

Intermediate/highrisk by EPI1

2

3

4 5

1 458 subjects received

EPI test results

2 93 were low risk (<15.6)

3 63% were recommended to

defer their biopsy (Bx)

4 This was a 92% compliance rate

to MD recommendation

5 72% complied with physician

recommendation to go to biopsy

compared to the standard of care

(SOC) arm (39%). See Supplemental

Table S2 — “Clinical Utility Paper” for

SOC arm outcomes.

100%

80%

60%

40%

20%

0%

0–5

10–1

5

EPI scores

5–10

15–2

0

20–3

0

30–4

0

40–5

0

50–6

0

60–7

0

70–9

0

90–1

00

% biopsies performed, EPI arm% biopsies performed, Control arm% risk of HGPC 95% CI

<15.6low risk

<15.6intermediate and high risk

6

7

6 Biopsy decision rate is plotted as

a function of the EPI score and

superimposed on the light blue

area representing risk of HGPCa

from prior validation studies. Only

26% of EPI low risk (<15.6) subjects

proceeded with a biopsy compared

to 39% in the control arm. 72% of

EPI high risk (>15.6) proceeded

with biopsy compared to 39% in

the control arm.

7 Urologists used the <15.6 cutoff as a

rationale to support biopsy deferral.

Read about Cal’s journey:

exosomedx.com/ FightLikeCal

The ExoDx Prostate test performs especially well in the ≥ GG 3 with an NPV of 97%

Scores from the ExoDx Prostate Test range from 0 to 100, with the cut point at 15.6. Score ranges are proportional to increased likelihood for HGPCa.

60%

50%

40%

30%

20%

10%

0%0–10 10–20 20–30 30–40 40–50 50–60 ≥60

EPI score

Hig

h-g

rad

e p

rost

ate

canc

er r

isk

100

80

60

40

20

00

Exo

Dx

Pro

stat

e(Intelliscore)

20 40 60 80 100

Patient biopsy diagnosis

15.6 cut point

ISUP 1/BenignISUP 2ISUP 3ISUP 4ISUP 5

Key Points:• Every patient in this data is in

the intended use population (PSA 2–10ng/mL, presenting with initial biopsy, and 50 years and above)

• Consider age group and other standard of care factors when interpreting the results

Figure 1: Likelihood of finding HGPCa on biopsy in intended use population4,5

Figure 2: The EPI Test performed the same in two prospective validation studies published in top-tier peer-reviewed journals over 1,000 patients4,5

Key Points:• EPI was able to accurately classify

patients that were not likely to need a biopsy (Gleason 6/GG1) with a score of 15.6 or less. Note the density of blue below the cut point (indicating ISUP1/benign)

• EPI was able to accurately classify patients that were more likely to need a biopsy (Gleason 7/GG2) with a score of 15.6. Note the high density of yellow and red color above the cut point, indicating Gleason 7 and above (indicating higher grade group and need for biopsy)

• ISUP 1/benign: Gleason 6

• ISUP 2: Gleason 7/(3+4)

• ISUP 3: Gleason 7/(4+3)

This chart represents >1,000 patients who were candidates for initial biopsy. All patients were in the intended use population (50 years of age or older, and PSA 2–10ng/mL).

Interpreting the EPI score

Frequently asked questions

The EPI Test came back at “Higher Risk” but a biopsy result came back negative. How should I interpret this result?

The purpose of The EPI Test is to rule out patients who don’t need a biopsy. If you are below the 15.6 cut point, you have a very low (9%) chance of finding high-grade cancer upon biopsy. The chance of finding high-grade cancer upon a biopsy is illustrated in Figure 1.

What is the Negative Predictive Value (NPV)? Negative Predictive Value is a statistical measure that says how confident we are about a negative outcome. In the initial biopsy population, the NPV is 91%, at a cut point of 15.6. In the repeat biopsy population, the NPV is 92%, at a cut point of 15.6.6

What is the sensitivity of The EPI Test? The sensitivity of The EPI Test is 92% in the initial biopsy population, and the sensitivity of The EPI Test is 82% in the repeat biopsy population.6 The sensitivity measures the proportion of actual GS7 and above that are correctly identified as positive.

What is the cut-point used to determine high risk vs. lower risk?

The EPI Test has been validated using a cut point of 15.6 to determine when patients are at lower risk for high-grade prostate cancer, defined as Gleason 7(3+4) or Grade Group 2 or higher. Patients with an EPI score below this cut point have a very low risk (9%) of not having high-grade prostate cancer.

Does The EPI Test distinguish between GS6 and GS7 and higher prostate cancer?

Yes. The EPI Test is optimized as a rule-out test to distinguish high-grade prostate cancer (defined as GS7 and above) from low-grade prostate cancer. Patients above the cut point of 15.6 are associated with high risk of high-grade prostate cancer. Patients below the cut point of 15.6 are associated with lower risk of high-grade prostate cancer. Reference Figure 1 to see the likelihood of finding HGPCa in the intended use population.

Is the score a percentage of risk? Recent data presented at ASCO GU 2019 clearly demonstrated that the EPI score is proportional to increased risk of finding HPGC upon biopsy. For example, an EPI score of 50 is associated with a 50% risk of finding HGPC upon biopsy (see Figure 1). The risk should be considered within the context of other patient parameters. A score of 60 or higher is not demonstrated to have higher risk of finding HPGC upon biopsy than a score of 50.

Why do I need to use your collection cup? The prostate biomarkers we are looking for have the highest concentration in the “first catch” urine sample, which is the first 15 mLs of the void and is mostly from the prostate. Using the ExoDx collection cup that we provide allows us to capture this first catch and discard additional urine that would dilute the sample.

Which RNA biomarkers are analyzed? PCA3, ERG and SPDEF.

What should I do if the patient voided 30 minutes ago? Please have the patient wait one full hour before providing a new sample. The EPI Test is most accurate when there is sufficient signal in the urine sample, which occurs with the first catch. We also offer an At-Home Collection kit that can be sent directly to the patient’s home for later collection.

This test was evaluated and its performance characteristics determined by Exosome Diagnostics, Inc. Exosome Diagnostics is certified under the Clinical Laboratory Improvement Amendments (CLIA) Act of 1988 as qualified to perform high complexity clinical testing. CLIA number — 22D2093470

Exosome Diagnostics and ExoDx are registered U.S. trademarks of Exosome Diagnostics, Inc.

Exosome Diagnostics, Inc.266 Second Ave., Suite 200Waltham, MA 02451www.exosomedx.com844-EXOSOME (844-396-7663)MKT 115

1. Ferlay, J et al. Cancer incidence and mortality worldwide: Sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015.

2. USPSTF Final Recommendation Statement Prostate Cancer Screening: wwwuspreventiveservicestaskforce.org, 2018.

3. Tutrone, R et al. Clinical utility of the exosome based ExoDx Prostate(IntelliScore) EPI test in men presenting for initial Biopsy with a PSA 2–10 ng/mL, Prostate Cancer and Prostatic Dis. 2020.

4. McKiernan J, Donovan M, et al. A Novel Urine Exosome Gene Expression Assay to Predict High-grade Prostate Cancer at Initial Biopsy. JAMA Oncology, July 2016.

5. McKiernan J., and Donovan, M. et al., A Prospective Adaptive Utility Trial to Validate Performance of a Novel Urine Exosome Gene Expression Assay to Predict Exosome Gene High-grade Prostate Cancer in Patients with Prostate-specific antigen 2-10ng/ml at Initial Biopsy, Eur Urol, 2018.

6. McKiernan, J., et al. A urine-based Exosomal gene expression test stratifies risk of high-grade prostate Cancer in men with prior negative prostate biopsy undergoing repeat biopsy. BMC Urol 20, 138 (2020). https://doi.org/10.1186/s12894-020-00712-4.

7. Haese A. et al. Multicenter Optimization and Validation of a 2-Gene mRNA urine test for Detection of Clinically Significant Prostate Cancer before Initial Prostate Biopsy. J Urol. 2019.

8. Loeb S. and Catalona, W. The Prostate Health Index: a new test for the detection of prostate cancer. Ther Adv Urol. 2014.

9. Beckman Coulter PMA Approval letter, https://www.accessdata.fda.gov/cdrh_docs/pdf9/P090026A.pdf, 2012.

10. Punnen, S. et al. Finding the Wolf in Sheep’s Clothing: The 4kscore Is a Novel Blood Test That Can Accurately Identify the Risk of Aggressive Prostate Cancer. Rev Urol. 2015.

Experience the power of exosomes

Based on proprietary algorithm

Strength of the Test

Risk assessment for Prostate Cancer

Non-invasive urine test

Genomic marker test

PSA excluded from algorithm

Standard of Care (SOC) parameters / clinical risk factors are excluded from algorithm

No DRE required

ExoDX Select MDx7 PHI8,9 4K10

At-Home Collection Kit

Documents

Department of Veterans Affairs FSS Authorized Federal