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  • MammaPrint® | Agendia
    Oncotype DX and MammaPrint are statistically different with P values 01 the mean cost of Oncotype DX is 27 882 with a standard error of 1 455 and the mean cost of MammaPrint is 21 598 with a standard error of 1 246 The effectiveness of Oncotype DX and MammaPrint are statistically different with P values 01 the mean effectiveness of Oncotype DX is 7 36 with a standard error of 0 07 and the mean effectiveness of MammaPrint is 7 46 with a standard error of 0 07 Therefore the use of MammaPrint as a prognostic assessment tool is not only cost effective it also appears to circumvent the ambiguity in the Oncotype DX RS results RASTER Study RASTER Study Prospective Analysis 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 TRANSBIG Study Published in 2006 by Buyse et al the independent study conducted on behalf of the TRANSBIG consortium which consisted of 302 patients found that MammaPrint can stratify patients into a binary risk classification of either Low Risk or High Risk with a statistically significant difference in the probability of metastasis free survival at 10 years Results Low Risk patients have a 10 95 CI 4 15 chance of cancer recurrence within 10 years without any adjuvant treatment either hormonal therapy or chemotherapy High Risk patients have a 29 95 CI 22 35 chance of recurrence within 10 years without any adjuvant treatment either hormonal therapy or chemotherapy Predictive Adjuvant Chemotherapy predictive data 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

    Original URL path: http://www.agendia.com/healthcare-professionals/managed-care/mammaprint/ (2016-05-01)
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  • BluePrint® | Agendia
    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 Healthcare Economics Use of the BluePrint molecular subtyping signature provides significant value and cost savings to the physicians patients and healthcare systems treating breast cancer patients The proper clinical use of BluePrint Provides actionable results 100 of the time subtype definitively determined for every patient Provides the information needed by physicians to withhold ineffective drugs in patients that will not benefit from them thereby saving payers the cost of an expensive yet ineffective course of therapy or therapies Avoids exposure to unnecessary drug toxicities reducing the number of patients experiencing adverse effects of unnecessary and ineffective treatments Provides the information needed by physicians to administer trastuzumab based e g Herceptin or endocrine therapy when they will benefit the patient expediting the use of the best available alternative therapy thereby eliminating the trial and error of several sequential treatments Limits the use of expensive biologic oncologic therapies to only the patients whom will benefit thereby saving payers the cost of an expensive unnecessary and ineffective course of treatment and Increases the quality of

    Original URL path: http://www.agendia.com/healthcare-professionals/managed-care/blueprint/ (2016-05-01)
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  • TargetPrint® | Agendia
    been demonstrated in resolving the discordance between current methods for HER2 e g CISH versus IHC 1 reducing the number of false negative classifications for hormone receptor status and false positive results of HER2 status2 and further evaluating tumors classified as ER negative PR positive tumors classified as ER positive PR negative and tumors classified as triple negative ER PR and HER2 negative 3 Physicians identified key clinical situations in which they currently order TargetPrint gene expression analysis equivocal or unreliable IHC result discordance between two separate tests or discordance of test results and clinicopathologic features or technical failure of IHC FISH CISH 4 References Healthcare Economics Use of the TargetPrint ER PR HER2 expression assay provides additional clinical information and value to the physicians patients and healthcare systems treating breast cancer patients As compared to IHC TargetPrint delivers an added benefit to the diagnostic process IHC provides a semi quantitative positive or negative result whereas the gene expression result provided by TargetPrint allows physicians to integrate the absolute level or ER PR and HER2 gene expression into treatment planning The addition of TargetPrint microarray can resolve common clinical enigmas posed by protein chemistry methods and make a substantial contribution

    Original URL path: http://www.agendia.com/healthcare-professionals/managed-care/targetprint/ (2016-05-01)
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  • Insurance Coverage | Agendia
    may influence a patient s decision in selecting diagnostic and treatment options Below are some important milestones in Agendia s mission to provide all patients with access to cost effective care MammaPrint is covered by Medicare Medicare had recognized MammaPrint as reasonable and necessary and covered the service under a Local Coverage Determination since 2009 noting that by analyzing the individual activity of the tumor s genes MammaPrint enables a more accurate prognosis of breast cancer recurrence to assist physicians in dealing with their patient s breast cancer MammaPrint is medically necessary in conjunction with the diagnosis and treatment of breast cancer patients with Stage I or Stage II disease and unlike other breast cancer recurrence tests on the market the use validity and result report is independent of tamoxifen treatment The Medicare coverage policy cites these specific patient indications where MammaPrint is reasonable and necesary Based on analysis of peer reviewed publications FDA clearance local guidance by practicing oncologists review by knowledgeable pathologists and guidance from our Contractor Advisory Committee oncologists Palmetto GBA determined that the MammaPrint genetic expression profiling test is considered safe and effective and reasonable and necessary to contribute to breast cancer prognoses with the following limitations Tumor size 5 0 cm Lymph node negative Lymph Node Positive up to 3 nodes Stage I and II invasive breast cancer ER or ER HER2 or HER2 Tamoxifen independent Nodal micrometastases 2 0mm MammaPrint is covered by many payors and private insurance plans throughout the United States For coverage information about a specific health plan please contact our Billing department at 888 363 7868 or by email at billing agendia com Agendia is a compassionate company offering a wide range of financial assistance programs based on individual financial status Agendia offers the following programs to meet patient s

    Original URL path: http://www.agendia.com/healthcare-professionals/managed-care/insurance-coverage/ (2016-05-01)
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  • Current Clinical Studies | Agendia
    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 on chemotherapy endocrine versus endocrine alone treatment decisions in lymph node negative hormone receptor positive HER2 negative breast cancer patients who received an Oncotype DX intermediate score 18 30 Secondary objectives Assess the impact of MammaPrint on chemotherapy endocrine versus endocrine alone treatment decisions in lymph node positive N1 hormone receptor positive HER2 negative breast cancer patients who received an Oncotype DX intermediate score 18 30 Describe the frequency of chemotherapy endocrine versus endocrine alone decisions in Oncotype DX intermediate score patients Assess the distribution of MammaPrint Low and High Risk in patients with an intermediate recurrence score Assess concordance of TargetPrint ER PR and HER2 results with Oncotype DX ER PR and HER2 and with locally assessed IHC FISH ER PR and HER2 Compare clinical subtype based on IHC FISH ER PR HER2 and Ki 67 if available with BluePrint molecular subtype Inclusion criteria Women with histologically proven invasive stage I II node negative or node positive N1 hormone receptor positive HER2 negative breast cancer who received an Oncotype DX intermediate score 18 30 18 years of

    Original URL path: http://www.agendia.com/healthcare-professionals/managed-care/current-clinical-studies/ (2016-05-01)
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  • Clinical Studies | Agendia
    indications for use In the first ever prospective observational study for a breast cancer recurrence assay the five year prospective results of the RASTER study were published indicating that chemotherapy may be safely withheld in MammaPrint identified Low Risk breast cancer patients The Low Risk patient group which primarily chose to forego chemotherapy had a 97 distant recurrence free interval DRFI at 5 years Published studies continue to support the strong prognostic and predictive clinical utility of Agendia s genomic assays and ongoing large multi site clinical trials seek to expand clinical indications for use 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 With Agendia s state of the art genomics laboratories in California and the Netherlands the company is actively engaging academic centers medical institutions and pharmaceutical companies in clinical trials collaboration opportunities globally For more information on Agendia s clinical study opportunities please contact Agendia Medical Affairs at clinicaltrials agendia com What is genomic testing Genomic tests look at your specific tumor s genes to help find out what s driving its growth Using gene expression testing to help design a tailored treatment plan is called personalized medicine These are not the same as genetic tests that determine your inherited risk or hereditary predisposition for cancer Your physician will assess many factors prior to determining your treatment plan including the size of the tumor lymph node

    Original URL path: http://www.agendia.com/patient/breast/current-clinical-studies/ (2016-05-01)
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  • Study Shows Half of Early-Stage Breast Cancer Patients May Safely Avoid Chemotherapy | Agendia
    undergo chemotherapy and still have excellent outcomes The results of the peer reviewed study called MicroarRAy PrognoSTics in Breast CancER or RASTER conducted in 16 community based clinics in the Netherlands were published online by The International Journal of Cancer and will later appear in the journal s print edition The RASTER study is considered unique by its co authors because it is the first and only study to prospectively evaluate the performance of a genomic breast cancer test by using outcome data in this case through follow up of the patient cohort for five years The study showed that incorporating MammaPrint results along with the traditional clinical parameters will significantly reduce the number of women who need chemotherapy allowing them to avoid the side effects and toxicity of treatment some of which can be permanent and debilitating said breast surgeon Alison Laidley M D FACS with Texas Breast Specialists Texas Oncology Dallas The study also showed that MammaPrint identified 30 percent more patients as Low Risk than traditional clinical parameters such as tumor size grade patient age and lymph node status which are often used in the U S to determine risk of recurrence MammaPrint is a 70 gene breast cancer assay performed on both fresh and FFPE tumor tissue developed by Agendia Of the prognostic tests commercially available for breast cancer this is the first and only prospective validation to include outcome data said David Macdonald CEO of Agendia the company that developed and provides the MammaPrint test MammaPrint can be administered to virtually all early stage breast cancer patients not just those with certain disease characteristics as with other tests limited to certain receptor and lymph node status Finally MammaPrint results benefit the physician by clearly categorizing all patients as high or low risk eliminating the uncertainty of indeterminate scores reported by other genomic test methods About MammaPrint MammaPrint is the first and only FDA cleared IVDMIA breast cancer recurrence assay The unique 70 gene signature of MammaPrint provides the unprecedented ability to identify which early stage breast cancer patients are at risk of distant recurrence following surgery independent of estrogen receptor status and any prior treatment Unlike previous generation genomic tests MammaPrint evaluates all of the critical molecular pathways involved in the breast cancer metastatic cascade It analyzes 70 critical genes that comprise a definitive gene expression signature more than triple the number of genes analyzed by previous generation tests and stratifies patients into two distinct groups low risk or high risk of distant recurrence With MammaPrint there are no intermediate results About Agendia Agendia is a leading molecular diagnostic company that develops and markets FFPE based genomic diagnostic products which help support physicians with their complex treatment decisions Agendia s breast cancer Symphony suite was developed using unbiased gene selection analyzing the complete human genome ensuring 100 definitive results for cancer patients Symphony includes MammaPrint the first and only FDA cleared IVDMIA breast cancer recurrence assay as well as BluePrint a molecular subtyping assay TargetPrint

    Original URL path: http://www.agendia.com/study-shows-half-of-early-stage-breast-cancer-patients-may-safely-avoid-chemotherapy/ (2016-05-01)
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  • Clinical Studies | Agendia
    prognostic and predictive clinical utility of MammaPrint for early stage breast cancer patients and large multi institutional clinical trials such as MINDACT and ISPY 2 can be expected to expand the assay s clinical importance and indications for use Recently the five year prospective results of the RASTER study were published indicating that chemotherapy may be safely withheld in Low Risk breast cancer patients Published studies continue to support the strong prognostic and predictive clinical utility of Agendia s genomic assays and ongoing large multi site clinical trials seek to expand clinical indications for use 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 With Agendia s state of the art genomics laboratories in California and the Netherlands the company is actively engaging academic centers medical institutions and pharmaceutical

    Original URL path: http://www.agendia.com/patient/colon-cancer-patients/colon-clinical-studies/ (2016-05-01)
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