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  • Current Clinical Studies | Agendia
    a patient s primary tumor have become important prognostic tools for breast cancer patients This study is designed to test the ability of MammaPrint in combination with TargetPrint BluePrint and TheraPrint as well as traditional pathologic and clinical prognostic factors to predict responsiveness to neo adjuvant chemotherapy in patients with LABC Objectives To determine the predictive power of chemosensitivity of the combination of MammaPrint and BluePrint as measured by pCR To compare TargetPrint single gene read out of ER PR and HER2 with local and centralized IHC and or CISH FISH assessment of ER PR and HER2 To identify possible correlations between the TheraPrint Research Gene Panel outcomes and chemoresponsiveness To identify and or validate predictive gene expression profiles of clinical response resistance to chemotherapy To compare the three BluePrint molecular subtype categories with IHC based subtype classification Inclusion criteria Women with histologically proven invasive breast cancer T2 3 5cm T4 N0 M0 or T2 4N1M0 DCIS or LCIS are allowed in addition to invasive cancer at T2 or T3 level Age 18 years Measurable disease in two dimensions Adequate bone marrow reserves adequate renal function and hepatic function Signed informed consent Exclusion criteria Patients with inflammatory breast cancer Tumor sample shipped to Agendia with 30 tumor cells or that fails QA or QC criteria Patients who have had any prior chemotherapy radiotherapy or endocrine therapy for the treatment of breast cancer Any serious uncontrolled inter current infections or other serious uncontrolled concomitant disease Click image to enlarge PROMIS PRospective study Of MammaPrint in breast cancer patients with an Intermediate recurrence Score PROMIS Study Design This will be a prospective case only study to measure the impact of MammaPrint on adjuvant treatment in patients with an Oncotype DX intermediate score 18 30 Eligible patients with an Oncotype DX intermediate score will have their tumor sample analyzed for MammaPrint BluePrint and TargetPrint Patients can t start treatment before the MammaPrint result is received and taken into consideration for the adjuvant treatment plan The clinical data is to be entered online There will be two Case Report Forms CRF The first CRF must be completed before receiving the MammaPrint result This CRF will capture baseline patient characteristics pathology information Oncotype DX score and the recommended treatment plan without knowing the MammaPrint result The second CRF will be completed within 4 weeks after receiving the MammaPrint result and will capture the recommended treatment based on MammaPrint A sample size of 820 lymph node negative hormone receptor positive HER2 negative breast cancer patients is required to detect a 20 overall treatment change 5 significance and 90 power In addition to the 820 lymph node negative patients lymph node positive N1 hormone receptor positive HER2 negative breast cancer patients will be enrolled to assess the impact of MammaPrint in lymph node positive N1 patients as a secondary objective It is expected that approximately 50 70 institutions in the US will participate Objectives This study has the following objectives Primary objective Assess the impact of MammaPrint

    Original URL path: http://www.agendia.com/healthcare-professionals/breast-cancer/current-clinical-trials/ (2016-05-01)
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  • MammaPrint | Agendia
    study of 302 adjuvantly untreated patients with at least ten years of follow up 2 Analysis of this data set in line with FDA standards conducted in a study by Delahaye et al showed that the proportion of patients who remained free from distant metastases at 10 years was 90 in the Low Risk group and 71 in the High Risk group MammaPrint was found to provide prognostic information beyond what could be determined from patient age tumor grade tumor size and ER status in a population of lymph node negative patients none of whom received any adjuvant chemotherapy 9 Click image to enlarge Additional studies have been published proving MammaPrint s additive prognostic ability in All age groups Small primary tumors Up to 3 Positive Lymph Nodes LN ER HER2 Ethnic groups Clinical Utility Adjuvant Chemotherapy predictive data 7 A study published in 2010 by Knauer et al demonstrated the predictive value of MammaPrint for adjuvant chemotherapy in early stage breast cancer Patients allocated to High Risk by MammaPrint resulted in a statistical separation in distant disease free survival DDFS with a statistically significant p value p 0 01 In the High Risk group the endocrine only treated arm had a 76 DDFS and the endocrine chemotherapy arm had a 88 DDFS This resulted in an overall 12 absolute benefit and a 50 relative benefit overall for this group In the MammaPrint Low Risk group no statistically significant benefit for the chemotherapy endocrine therapy arm vs endocrine therapy only arm was achieved Results Low Risk 10 chance of recurrence no statistical benefit from chemotherapy High Risk 29 chance of recurrence statistical benefit from chemotherapy Adapted from Knauer et al Breast Cancer Res Treat 2010 Feb Click image to enlarge RASTER Study Prospective Analysis 1 Published in January of 2013 the RASTER study microarRAy prognoSTics in breast cancER proved the ability of MammaPrint to accurately stratify breast cancer patients as either Low Risk or High Risk better than the available traditional clinical parameters RASTER is the first and only 5 year prospective outcome based data for any prognostic breast cancer risk of recurrence assay that has been published The study consisted of 427 patients that were enrolled at 16 centers performed in the community setting Results MammaPrint results were incorporated into the decision making process for patients and physicians with regards to the use of adjuvant chemotherapy 97 of the MammaPrint identified Low Risk patient group which primarily chose to forego chemotherapy were disease free after 5 years MammaPrint identified 20 more Low Risk patients as compared to traditional clinical parameters and despite this increased allocation in patients the Low Risk group still had an excellent 97 DRFI Low Risk MammaPrint result is shown to correlate with excellent outcome High Risk MammaPrint result is shown to correlate with poorer outcome and higher response to adjuvant chemotherapy Adapted from Drukker et al Int J Cancer 2013 Click image to enlarge TRANSBIG Study 2 Published in 2006 by Buyse et al the

    Original URL path: http://www.agendia.com/healthcare-professionals/breast-cancer/mammaprint/ (2016-05-01)
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  • BluePrint | Agendia
    Basal type n 17 Four of 92 4 IHC FISH triple negative TN patients were reclassified as Luminal type n 2 or HER2 n 2 Neoadjuvant chemotherapy NCT pCR rates were 2 in Luminal type A and 7 Luminal type B patients versus 10 pCR in IHC FISH HR HER2 patients The NCT pCR rate was 53 in BluePrint HER2 type patients This is significantly superior p 0 047 to the pCR rate in IHC FISH HER2 patients 38 The pCR rate of 36 of 75 IHC FISH HER2 HR patients reclassified as BluePrint Luminal type is 3 NCT pCR for BluePrint Basal type patients was 49 of 140 35 comparable to the 34 of 92 pCR rate 37 in IHC FISH triple negative patients Clinical Utility BluePrint Classifies breast cancer subtypes more precisely than IHC FISH 10 In a 2013 study conducted by Glück et al the evaluation of pathologic complete response pCR rates with neoadjuvant therapy among patients stratified by traditional subtyping vs molecular subtyping was performed The results showed that BluePrint MammaPrint allowed determination of a patient s potential level of responsiveness to neoadjuvant chemotherapy more accurately vs IHC FISH with better correlation with long term clinical treatment outcomes 21 of patients reclassified as Low Risk Luminal type A with molecular subtyping not identified by IHC The Distant Metastasis Free Survival DMFS rate for this group was 93 at 5 years and showed little if any benefit to chemotherapy pCR 6 Ability to identify High Risk Luminal type B patients correlated with worse DMFS as compared to Low Risk Luminal type A Identified 43 of HER2 patients as having a dominant Luminal pathway which may lead to alternative treatment planning Adapted from Glück et al Breast Cancer Res Treat 2013 Click image to enlarge BluePrint Molecular Subtyping reclassifies up to 25 of breast cancers 11 In a study with over 300 patients with good clinical annotations and long term clinical follow up performed by renown medical oncologist Massimo Cristofanilli from Thomas Jefferson University it was determined that MammaPrint BluePrint molecular subtyping was more accurate at identifying the biology of the disease as compared to central IHC evaluation The results of this study showed that approximately 50 HER2 as determined by IHC were reclassified as Luminal type A or B by molecular subtyping as well as 17 patients who were originally classified as triple negative by IHC were shown to be HER2 pathway driven Overall up to 25 of all breast cancers were reclassified These results again showed the clinical implications in breast cancer treatment decisions as determined by BluePrint functional molecular subtyping Dr Whitworth on the Importance of Additional HER2 Subtyping Pat Whitworth MD Nashville Breast Center discusses results from the prospective NBRST study which compares the classification of breast cancer using traditional IHC subtyping vs functional molecular subtyping with the 80 gene BluePrint Molecular Subtyping assay Share This Video http www youtube com watch v IawIT snUyg Dr Whitworth on the Importance of Additional HER2 Subtyping

    Original URL path: http://www.agendia.com/healthcare-professionals/breast-cancer/blueprint/ (2016-05-01)
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  • TargetPrint | Agendia
    reference laboratories 15 ER PR and HER2 read outs are determined by measuring the level of gene expression by microarray for the three biomarkers The single read out is performed on quality controlled DNA microarrays in Agendia s CLIA Clinical Laboratory Improvement Act and CAP College of American Pathologists accredited laboratories in Irvine CA and Amsterdam The Netherlands A positive score in ER or PR corresponds to 1 tumor cells demonstrating positive nuclear staining with an immunohistochemistry IHC assay while a positive score in HER2 correlates with a 3 score by IHC or a HER2 CEP17 ratio of 2 0 by fluorescence in situ hybridization FISH Roepman P et al Clin Cancer Res 2009 15 7003 7011 Validation TargetPrint has been validated on over 500 breast cancer tumor samples from three independent studies Validation was achieved using Immunohistochemistry tests IHC performed at an independent US based CLIA and CAP accredited national reference laboratory for comparison The Estrogen Receptor ER Progesterone Receptor PR and HER2 microarray values were compared to the IHC results which were assessed at one central laboratory yielding a 93 concordance 95CI 91 95 for ER an 83 concordance 95CI 80 86 for PR and a 96 concordance 95CI 94 98 for HER2 respectively 15 For ER and PR a threshold of 1 IHC positively stained tumor cells was used to classify samples as positive for HER2 an IHC score of 3 was considered positive In the case of 2 samples FISH assessed final HER2 amplification status Roepman P et al Clin Cancer Res 2009 15 7003 7011 Clinical Utility Accurate assessment of hormone receptor status is important since these bio markers have shown to be predictive of therapeutic response such as endocrine therapy Tamoxifen for ER patients and trastuzumab Herceptin for HER2 patients In a study which

    Original URL path: http://www.agendia.com/healthcare-professionals/breast-cancer/targetprint/ (2016-05-01)
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  • ColoPrint Results | Agendia
    Colon Cancer ColoPrint Results Home ColoPrint Results Current Clinical Studies Customer Portal Ordering ColoPrint identifies a patient s risk of distant local or regional relapse and stratifies approximately 2 3 of patients as low risk and 1 3 of patients as high risk The combination of ColoPrint with the patient s clinical and pathological factors further personalizes the estimate of a patient s risk of relapse The information is intended to inform physicians about appropriate treatment options Low Risk Result ColoPrint Low Risk Sample Report A Low Risk result means that a patient with stage II colon cancer has an 8 risk of relapse within 3 years and a 11 risk of relapse within 5 years without adjuvant systemic therapy 22 High Risk Result ColoPrint High Risk Sample Report A High Risk result means that a patient with stage II colon cancer has an 20 risk of relapse within 3 years and a 22 risk of relapse within 5 years without adjuvant systemic therapy 22 We d Love To Hear From You Name Email Questions Comments Concerns Questions Comments Concerns Comments This field is for validation purposes and should be left unchanged Resources Online Ordering Publications Studies Physician Education Breast

    Original URL path: http://www.agendia.com/healthcare-professionals/colon-cancer/coloprint-results/ (2016-05-01)
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  • Current Clinical Studies | Agendia
    trials collaboration opportunities globally Currently Agendia is enrolling institutions and cancer centers worldwide in the following studies Early stage breast cancer MINT The Multi Institutional Neo Adjuvant Therapy MammaPrint Project trial NCT01501487 PROMIS PRospective Study Of MammaPrint in Patients With an Intermediate Recurrence Score NCT01617954 NBRST Neo adjuvant Breast Registry Symphony Trial NCT01479101 Open not currently enrolling or adding new institutions Early stage colon cancer PARSC A Prospective Study for the Assessment of Recurrence Risk in Stage II Colon Cancer Patients Using ColoPrint NCT00903565 For more information on Agendia s clinical study opportunities please contact Agendia Medical Affairs at clinicaltrials agendia com Click on the trials below to learn more PARSC ColoPrint and the PARSC Clinical Trial for Colon Cancer Recurrence Risk The PARSC Prospective Analysis of Risk Stratification by ColoPrint Trial is a multi center multi national prospective study for the assessment of recurrence risk in Stage II and III Colon Cancer patients This study will address the feasibility and quality assurance of the ColoPrint gene expression profile in clinical practice ColoPrint risk assessment results will be compared to the risk assessment resulting from various clinical parameters following local ASCO criteria and independent investigator criteria Primary Objective To validate the performance of ColoPrint in estimating the 3 year relapse rate in patients with stage II colon cancer Secondary Objectives To assess the feasibility of using the ColoPrint test in the clinical setting To compare the risk assessment in stage II patients using the ColoPrint profile vs a clinical risk assessment based on 1 Investigator s assessment of risk and 2 ASCO high risk recommendations T4 lesions perforation obstruction inadequate node sampling less than 12 nodes or poorly differentiated histology To establish the proportion of Low Risk and High Risk ColoPrint profiles in stage II colon cancer patients in various

    Original URL path: http://www.agendia.com/healthcare-professionals/colon-cancer/current-clinical-studies/ (2016-05-01)
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  • Customer Portal & Ordering | Agendia
    Test Request Form TRF Click below to download and print a paper TRF Please complete and fax to 866 756 7548 Include a copy in the specimen transportation kit provided Outside the Americas Test Request Form TRF Click below to download and print a paper TRF Please complete and fax to 31 20 462 1505 Include a copy in the specimen transportation kit provided Agendia Online Customer Portal Your tool to securely streamline Agendia case management ColoPrint Specimen Requirements The test requires at least a 6 x 6 x 3 mm sample of the fresh unfixed tumor specimen placed into RNARetain within one hour of surgery Whenever possible send at least two biopsies The RNARetain preservative and the biopsy punch are provided in the ColoPrint collection and transport kit The biopsy punch procures a 6 x 6 x 3 mm sample of the tumor tissue The specimen must contain sufficient tumor tissue to allow an analysis of the tumor specific biology Tumors are very often covered or surrounded with adenoma or normal mucosa To minimize the presence of this tissue bisect the fresh tumor to expose the invasive component of the tumor for Agendia tissue sampling Please see the Colon Cancer Specimen Sampling guide below for more details For additional information on specimen sampling or specimen requirements please contact our Customer Care representatives at 888 321 2732 or by email at customercare agendia com and they will gladly assist you Outside the Americas Please contact our Customer Care representatives at 31 20 462 1510 or by email at customerservice agendia com and they will be happy to help Specimen Collection and Transportation Kit Ordering To order Specimen and Transportation Kits please click on the button to submit a request Note Please allow up to four business days for delivery For

    Original URL path: http://www.agendia.com/healthcare-professionals/colon-cancer/ordering-instructions/ (2016-05-01)
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  • Test Results | Agendia
    The BluePrint 80 Gene Molecular Subtyping Assay was designed to distinguish the Basal type Luminal type and HER2 type ERBB2 functional molecular subtypes of tumors 12 The BluePrint assay determines the RNA levels of 80 genes that best discriminate among these three distinctive subtypes Tumors from a cohort of 200 patients were used for the development of gene expression profiles specific for the Basal type Luminal type and HER2 type breast cancers Sophisticated bio informatic analysis resulted in the identification of the 80 most representative genes to discriminate the individual molecular subtypes 58 genes compose the Luminal type profile 4 genes compose the HER2 type ERBB2 type profile and 28 genes compose the Basal type profile 10 genes overlap between profiles A nearest centroid classification procedure utilizing the 80 gene profile is used to determine the functional molecular subtype for every individual patient sample 12 BluePrint Luminal type Result Luminal type breast cancers are characterized by gene expression of luminal epithelial cells that line the breast ducts and glands The Luminal type cancers are typically hormone receptor positive tumors and therefore responsive to endocrine therapy A Luminal type molecular subtyping result means that the tumor most closely resembles the Luminal type intrinsic subtype Patients classified as MammaPrint Low Risk and Luminal type can be expected to have a clinical course similar to luminal A usually treated with endocrine therapy Patients classified as MammaPrint High Risk and Luminal type can be expected to have a clinical course similar to luminal B patients who usually benefit from more aggressive treatment which may include chemotherapy BluePrint HER2 type Result The HER2 type breast cancers are characterized by amplification or over expression of the HER2 locus The HER2 type cancers are typically HER2 positive tumors HER2 neu positive HER2 type cancers tend to grow more quickly and may recur although they can often be treated with targeted therapies such as trastuzumab and lapatinib A HER2 type molecular subtyping result means that the tumor most closely resembles the HER2 type intrinsic subtype BluePrint Basal type Result Basal type breast cancers are characterized by gene expression of the basal myoepithelial cell origin The Basal type cancers are typically triple negative for ER PR and HER2 neu basal like with a specific gene expression profile Endocrine therapy and anti HER2 therapies such as trastuzumab and lapatinib are not believed to be effective against these cancers although chemotherapy is thought to be helpful A Basal type molecular subtyping result means that the tumor most closely resembles the Basal type intrinsic subtype TargetPrint TargetPrint determines the receptor status of breast cancer tumors using unbiased gene expression technology Quantitative assessment of ER PR and HER2 expression adds confidence to conventional hormone receptor status results TargetPrint Results for ER PR A positive score in ER or PR corresponds to 1 tumor cells demonstrating positive nuclear staining with an immunohistochemistry IHC assay The level of ER and PR is prognostic in early stage breast cancer and predictive for response to tamoxifen and

    Original URL path: http://www.agendia.com/healthcare-professionals/breast-cancer/test-results/ (2016-05-01)
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