Agendia Terms & Conditions

Specimen Registration Confirmation

Requisition Number : SA06

Registration Date : 15-May-2020

Client information
Client Name : RoW Account

Requesting Physician : Amy

Additional Report Physician(s) : [email protected],[email protected],[email protected],

[email protected],[email protected]

Patient information Sample information

Last Name : Raj Case Type : FFPE Breast Cancer Prognosis (FFP)

First Name : Sarmilla Specimen Id : SA06

Date of Birth : 15-June-1994 Transport Type : Block(s)

Gender : Female Specimen Type : Needle Core

Patient ID/MRN : RA06 Collection Date : 15-May-2020

Reference : Dr. S Requested Tests

Send and Hold : Yes MammaPrint : Yes

Remarks : Blue Print : No

 Page 1 of 1

PATIENT NAME: ReportUploadAMS3, Repor DOB:

GENDER: Female ORDERED BY: AMS-StagingClient2, Physician1 REQUISITION #: ReportUploadAMS3
SPECIMEN ID: A) ACCOUNT: AMS-Staging Client 2 SPECIMEN TYPE: FFPE, Needle Core
PATIENT/MRN: SPECIMEN SOURCE:
CUSTOMER REF: COLLECTED DATE: 06-Sep-2017
RECEIVED DATE: 07-Sep-2017
REPORTED DATE: 03-Oct-2017

BluePrint® Result Luminal-type

According to the 2013 St Gallen Consensus regarding the treatment of women with early breast cancer, identification of intrinsic subtypes is most precise using molecular
technologies, such as gene expression profiling by microarray.1 The BluePrint test result represents the numerical outputs of an 80-gene microarray-based signature that
assesses a breast tumor for its molecular subtype by calculating the correlation scores between its gene expression patterns and a template for each of three molecular subtypes
(Luminal-type, HER2-type, or Basal-type). Each tumor will have 3 individual scores, and the highlighted molecular subtyping classification of each tumor is determined by the
molecular subtype with the highest correlation score. Luminal-type breast cancers can be sub-stratified into “Luminal A” and “Luminal B” using the MammaPrint categorical result
of “Low Risk” and “High Risk”, respectively, in combination with the BluePrint Luminal molecular subtype.

Luminal-type: +0.415

HER2-type: -0.128 a+0.42

” •
Basal-type: -0.265

Additional Comments:
Enrichment due to large DCIS component.

Assay Description
BluePrint, a microarray-based assay, has been developed to classify both fresh and formalin-fixed paraffin embedded (FFPE) breast tumor samples into one of three molecular
subtypes (Luminal-type, HER2-type, or Basal-type) based on functional molecular pathways. The BluePrint molecular subtyping profile (MSP) contains 80 genes, and it was
developed by evaluating early stage breast tumor samples with concordant ER, PR, and HER2 status by immunohistochemistry (IHC)/fluorescence in situ hybridization (FISH)
and mRNA expression levels. BluePrint is a combination of 3 correlation-type scores to each of the three functional subtypes: Luminal-type (endocrine dependent), HER2-type
(ERBB2 dependent), and Basal-type (triple negative). The BluePrint MSP has been shown to have high concordance with the subgroups (excluding normal-like) described by
Perou et al.2,3 Based on the analytical performance of BluePrint, the precision of classifying a sample as Luminal-type, HER2-type, or Basal-type is 99.3% for fresh and 98.6% for
FFPE, and the repeatability is 99.6% for fresh and 99.0% for FFPE.

Sign Off

Sign Off
Prof. René Bernards, PhD
Laboratory Director

Disclaimer
Agendia, NV (99D1030869) is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as qualified to perform high-complexity clinical testing. BluePrint is a laboratory developed test regulated under CLIA by CMS. Decisions
regarding care and treatment should not be based on a single test such as this test. Rather, decisions on care and treatment should be based on the independent medical judgment of the treating physician taking into consideration all available
information concerning the patient’s condition, including other pathological tests, in accordance with the standard of care in a given community. This test was performed at Agendia’s Amsterdam, NL laboratory. General information about BluePrint can
be found at www.agendia.com.

References:
1) Goldhirsch A, Winer EP, Coates AS, et al., Ann Oncol. 2013; 24(9):2206-23.
2) Perou CM, Sørlie T, Eisen MB, et al., Nature. 2000; 406(6797):747-52.
3) Krijgsman O, Roepman P, Zwart W, et al., Breast Cancer Res Treat. 2012; 133(1):37-47.

Agendia NV | Science Park 406 | 1098 XH Amsterdam | The Netherlands

Phone: +31 (0) 20 462 1510 | Fax: +31 (0) 20 462 1515 | [email protected] | www.agendia.com | © 2016
FFP17-300662/Agendia (Netherlands) R-ROW-014-V3
Summary of Results
PATIENT NAME: ReportUploadAMS3, Repor DOB:
GENDER: Female ORDERED BY: AMS-StagingClient2, Physician1 REQUISITION #: ReportUploadAMS3
SPECIMEN ID: A) ACCOUNT: AMS-Staging Client 2 SPECIMEN TYPE: FFPE, Needle Core
PATIENT/MRN: SPECIMEN SOURCE:
CUSTOMER REF: COLLECTED DATE: 06-Sep-2017
RECEIVED DATE: 07-Sep-2017
REPORTED DATE: 03-Oct-2017

Summary of Results: Low Risk Luminal-type (A)

Risk of Recurrence Molecular Subtype
Low Risk Luminal-type

MammaPrint® FFPE: 70-Gene Breast Cancer Recurrence Assay

b
Low Risk
+0.365

-1.0 0.0 +1.0

Low Risk Population Average1

Distant Recurrence Probability 5 Year: 5% (95% CI: 1% - 9%)
without Treatment 10 year: 10% (95% CI: 4% - 15%)

BluePrint®: 80-Gene Molecular Subtyping Assay

Luminal-type: +0.415

HER2-type: -0.128 a
+0.42

” •
Basal-type: -0.265

Note: This information is provided for general informational purposes. It is not part of any official diagnostic report. Please refer to
individual MammaPrint and BluePrint reports for comments, assay information, disclaimer and references.

Agendia NV | Science Park 406 | 1098 XH Amsterdam | The Netherlands Page 1 of 2

Phone: +31 (0) 20 462 1510 | Fax: +31 (0) 20 462 1515 | [email protected] | www.agendia.com | © 2016
FFP17-300662/Agendia (Netherlands) M-ROW-001-V4
Explanation of Results

PATIENT NAME: ReportUploadAMS3, Report AREPORTED DATE: 03-Oct-2017

Adjuvant Response to Therapy

• The MammaPrint result provides independently validated, statistically significant, additive information for physicians to assist them in making treatment decisions
for early stage breast cancer patients.
• If the risk assessment by MammaPrint and clinicopathological characteristics is concordant and indicates a Low Risk of recurrence, endocrine therapy (ET) alone
should be adequate treatment.
• If the risk assessment by MammaPrint and clinicopathological characteristics is discordant, MammaPrint Low Risk and clinically stratified High Risk patients will
OLNHO\EHQHILWIURP(7DORQHIRUKLJKO\HQGRFULQHUHVSRQVLYHSDWLHQWV •(5SRVLWLYLW\ DVGHILQHGE\WKH6W*DOOHQFRQVHQVXVSDQHO6LQFHWKHULVNRI
recurrence for these patients is so low, they will likely gain little or no benefit from additional chemotherapy (CT).
• Other factors, such as age and co-morbidities, may influence the decision-making process for systemic adjuvant therapy shared between the physicians and
patients. Distant metastasis-free survival (DMFS) is defined as time from surgery to any distant metastasis.
Estimated benefit in breast cancer specific survival by trastuzumab:
For women with early-stage HER2-positive breast cancer, addition of trastuzumab to paclitaxel after doxorubicin and cyclophosphamide results in a 10-year absolute
benefit of 9% in overall survival (OS) and 11% in disease-free survival (DFS).3

Neoadjuvant Response to Therapy

Low Risk Luminal-type (A) Neoadjuvant Distant Metastasis-Free Survival (DMFS) by

Chemosensitivity4 Molecular Subtype

Subtype Results Chemosensitivity Relevance

• Low likelihood of pCR

Low Risk Luminal- • No expected benefit from chemotherapy
type (A) • Endocrine therapy further reduces risk

References: (1) Buyse M, Loi S, van’t Veer L et al., J Natl Cancer Inst. 2006;98(17):1183-92. (2) Knauer M, Mook S, Rutgers EJ et al., Breast Cancer Res Treat.
2010;120(3):655-61. (3) Perez EA, Romond EH, Suman VJ, et al., J Clin Oncol. 2014;32(33):3744-52. (4) Gluck S, de Snoo F, Peeters J et al., Breast Cancer Res Treat.
2013;139(3):759-67.

Agendia Summary Page

Disclaimer: The summary page is provided for general informational purposes only and is not part of any official diagnostic report. Please refer to the official individual patient
reports for final results. This information (including, without limitation, advice and recommendations) and services are neither medical nor health care advice for any individual
problem nor a substitute for advice and services from a qualified health care provider familiar with the patient’s medical history. All publication information can be found at
www.agendia.com.

Agendia NV | Science Park 406 | 1098 XH Amsterdam | The Netherlands Page 2 of 2

Phone: +31 (0) 20 462 1510 | Fax: +31 (0) 20 462 1515 | [email protected] | www.agendia.com | © 2016
FFP17-300662/Agendia (Netherlands) M-ROW-001-V4
 Page 1 of 1

PATIENT NAME: ReportUploadAMS3, Repor DOB:

GENDER: Female ORDERED BY: AMS-StagingClient2, Physician1 REQUISITION #: ReportUploadAMS3
SPECIMEN ID: A) ACCOUNT: AMS-Staging Client 2 SPECIMEN TYPE: FFPE, Needle Core
PATIENT/MRN: SPECIMEN SOURCE:
CUSTOMER REF: COLLECTED DATE: 06-Sep-2017
RECEIVED DATE: 07-Sep-2017
REPORTED DATE: 03-Oct-2017

BluePrint® Result Luminal-type

According to the 2013 St Gallen Consensus regarding the treatment of women with early breast cancer, identification of intrinsic subtypes is most precise using molecular
technologies, such as gene expression profiling by microarray.1 The BluePrint test result represents the numerical outputs of an 80-gene microarray-based signature that
assesses a breast tumor for its molecular subtype by calculating the correlation scores between its gene expression patterns and a template for each of three molecular subtypes
(Luminal-type, HER2-type, or Basal-type). Each tumor will have 3 individual scores, and the highlighted molecular subtyping classification of each tumor is determined by the
molecular subtype with the highest correlation score. Luminal-type breast cancers can be sub-stratified into “Luminal A” and “Luminal B” using the MammaPrint categorical result
of “Low Risk” and “High Risk”, respectively, in combination with the BluePrint Luminal molecular subtype.

Luminal-type: +0.415

HER2-type: -0.128 a+0.42

” •
Basal-type: -0.265

Additional Comments:
Enrichment due to large DCIS component.

Assay Description
BluePrint, a microarray-based assay, has been developed to classify both fresh and formalin-fixed paraffin embedded (FFPE) breast tumor samples into one of three molecular
subtypes (Luminal-type, HER2-type, or Basal-type) based on functional molecular pathways. The BluePrint molecular subtyping profile (MSP) contains 80 genes, and it was
developed by evaluating early stage breast tumor samples with concordant ER, PR, and HER2 status by immunohistochemistry (IHC)/fluorescence in situ hybridization (FISH)
and mRNA expression levels. BluePrint is a combination of 3 correlation-type scores to each of the three functional subtypes: Luminal-type (endocrine dependent), HER2-type
(ERBB2 dependent), and Basal-type (triple negative). The BluePrint MSP has been shown to have high concordance with the subgroups (excluding normal-like) described by
Perou et al.2,3 Based on the analytical performance of BluePrint, the precision of classifying a sample as Luminal-type, HER2-type, or Basal-type is 99.3% for fresh and 98.6% for
FFPE, and the repeatability is 99.6% for fresh and 99.0% for FFPE.

Sign Off

Sign Off
Prof. René Bernards, PhD
Laboratory Director

Disclaimer
Agendia, NV (99D1030869) is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as qualified to perform high-complexity clinical testing. BluePrint is a laboratory developed test regulated under CLIA by CMS. Decisions
regarding care and treatment should not be based on a single test such as this test. Rather, decisions on care and treatment should be based on the independent medical judgment of the treating physician taking into consideration all available
information concerning the patient’s condition, including other pathological tests, in accordance with the standard of care in a given community. This test was performed at Agendia’s Amsterdam, NL laboratory. General information about BluePrint can
be found at www.agendia.com.

References:
1) Goldhirsch A, Winer EP, Coates AS, et al., Ann Oncol. 2013; 24(9):2206-23.
2) Perou CM, Sørlie T, Eisen MB, et al., Nature. 2000; 406(6797):747-52.
3) Krijgsman O, Roepman P, Zwart W, et al., Breast Cancer Res Treat. 2012; 133(1):37-47.

Agendia NV | Science Park 406 | 1098 XH Amsterdam | The Netherlands

Phone: +31 (0) 20 462 1510 | Fax: +31 (0) 20 462 1515 | [email protected] | www.agendia.com | © 2016
FFP17-300662/Agendia (Netherlands) R-ROW-014-V3
 Page 1 of 1

PATIENT NAME: ReportUploadAMS3, Repor DOB:

GENDER: Female ORDERED BY: AMS-StagingClient2, Physician1 REQUISITION #: ReportUploadAMS3
SPECIMEN ID: A) ACCOUNT: AMS-Staging Client 2 SPECIMEN TYPE: FFPE, Needle Core
PATIENT/MRN: SPECIMEN SOURCE:
CUSTOMER REF: COLLECTED DATE: 06-Sep-2017
RECEIVED DATE: 07-Sep-2017
REPORTED DATE: 03-Oct-2017

MammaPrint® FFPE Result Low Risk

The breast cancer tissue sample submitted was analyzed by MammaPrint FFPE, an IVDMIA 70-Gene Profile of Breast Cancer for Metastatic Risk that has been validated to
correlate with high or low outcome risk for distant metastases in patients with invasive breast cancer.1 This risk assessment is based on a retrospective analysis of a prospective
observational study that included 345 breast cancer patients treated and not treated with adjuvant therapy.2 Treatment was selected according to clinical assessments that
included MammaPrint test results. The risk for distant metastases in unselected patients who did not receive adjuvant treatment was not studied; therefore, MammaPrint FFPE
should be used as a prognostic marker only. As a group, "Low Risk" patients like those in the MammaPrint FFPE clinical validation (RASTER) study have a 1.3% chance (95% CI
0-3.1), and "High Risk" patients have an 11.7% chance (95% CI 6.6-16.8) that their cancer will recur within 5 years (not accounting for any covariates other than the patient’s
MammaPrint FFPE status).

b
Low Risk
+0.365

-1.0 0.0 +1.0

Additional Comments:
Enrichment due to large DCIS component.

Assay Description
7KH86)'$KDVSURYLGHG,9'0,$FOHDUDQFHRI0DPPD3ULQWZLWK))3(WLVVXHIRUSDWLHQWVZLWK6WDJH,DQG,,LQYDVLYHEUHDVWFDQFHUWXPRUVL]H”5 cm, lymph node negative,
based upon the development and validation of the MammaPrint assay as reported in Nature, New England Journal of Medicine, JNCI, BMC Genomics, Pers. Medicine, and Ann
Oncol.3-8 The test is performed using a microarray-based gene expression profile that was independently validated on 5-year outcome data on a patient cohort.2 If a FFPE
sample’s MammaPrint Index (MPI) falls within a pre-defined area around the classification cut-off between -0.050 and +0.050, the classification accuracy is less than 90%. See
MammaPrint Physician’s Brochure found on www.agendia.com for more information.

a Sign Off

Sign Off
Prof. René Bernards, PhD
Laboratory Director

For In Vitro Diagnostic Use

Caution: U.S. Federal law restricts this device to sale by or on the order of a physician.
Agendia, NV (99D1030869) is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as qualified to perform high-complexity clinical testing. MammaPrint FFPE is an aid in estimating the prognosis of patients diagnosed with
breast cancer. Decisions on treatment should be based on the independent medical judgment of the treating physician taking into consideration all available information concerning the patient’s condition, including other pathological tests, in
accordance with the standard of care in a given community. MammaPrint was developed using adjuvantly untreated, lymph node negative, mainly European, patients to capture the biology of the primary tumor in a gene expression profile. The
metastasis free survival data is from an independent external patient group in Europe. This test was performed at Agendia’s Amsterdam, NL laboratory. General information about MammaPrint FFPE can be found at www.agendia.com.

References:
1) FDA label - USFDA Clearance; http://www.accessdata.fda.gov website.
2) Drukker CA et al. Int J Cancer 2013;133(4):929-36.
3) Van ’t Veer LJ et al. Nature 2002;415(31):530-536.
4) Van de Vijver MJ et al. New Engl J Med 2002; 347(25):1999-2009.
5) Buyse M et. al. J Natl Cancer Inst 2006; 98(17):1183-1192.
6) Glas AM et al. BMC Genomics 2006;7:278.
7) Delahaye LJM et al. Pers Med 2013;10:801.
8) Mook S et al. Ann Oncol 2010;21(4):717-722.

Agendia NV | Science Park 406 | 1098 XH Amsterdam | The Netherlands

Phone: +31 (0) 20 462 1510 | Fax: +31 (0) 20 462 1515 | [email protected] | www.agendia.com | © 2016

FFP17-300662/Agendia (Netherlands) R-ROW-013-V3