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PROSIGNA PRODUCT INSERTS AND MSDS

Prosigna Reports

Scientific Evidence Of The Prosigna Assay’s Clinical Performance

More comprehensive information for better treatment decisions

  • Real World Evaluation of the Prosigna/PAM50 Test in a Node-Negative Postmenopausal Swedish Population: A Multicenter Study
  • Analytical validation of the PAM50-based Prosigna Breast Cancer Prognostic Gene Signature Assay and nCounter Analysis System using formalin-fixed paraffin-embedded breast tumor specimens
  • Comparison of PAM50 Risk of Recurrence Score With Oncotype DX and IHC4 for Predicting Risk of Distant Recurrence After Endocrine Therapy

  • Factors Predicting Late Recurrence for Estrogen Receptor–Positive Breast Cancer





  • Predicting distant recurrence in receptor-positive breast cancer patients with limited clinicopathological risk: using the PAM50 Risk of Recurrence score in 1478 postmenopausal patients of the ABCSG-8 trial treated with adjuvant endocrine therapy alone
  • The PAM50 Risk-of-Recurrence Score Predicts Risk for Late Distant Recurrence after Endocrine Therapy in Postmenopausal Women with Endocrine-Responsive Early Breast Cancer


  • Prediction of Late Distant Recurrence After 5 Years of Endocrine Treatment: A Combined Analysis of Patients From the Austrian Breast and Colorectal Cancer Study Group 8 and Arimidex, Tamoxifen Alone or in Combination Randomized Trials Using the PAM50 Risk of Recurrence Score
  • PAM50 Risk of Recurrence Score Predicts 10-Year Distant Recurrence in a Comprehensive Danish Cohort of Postmenopausal Women Allocated to 5 Years of Endocrine Therapy for Hormone Receptor–Positive Early Breast Cancer


  • Prospective study of the impact of the Prosigna assay on adjuvant clinical decision-making in unselected patients with estrogen receptor positive, human epidermal growth factor receptor negative, node negative early-stage breast cancer


  • The West German Study Group Breast Cancer Intrinsic Subtype study: a prospective multicenter decision impact study utilizing the Prosigna assay for adjuvant treatment decision-making in estrogen-receptor-positive, HER2-negative early-stage breast cancer
  • Prospective, multicenter French study evaluating the clinical impact of the Breast Cancer Intrinsic Subtype- Prosigna® Test in the management of early-stage breast cancers



  • Tumour profiling tests to guide adjuvant chemotherapy decisions in early breast cancer (NICE Diagnostic Guidance)





  • Comparison of the Performance of 6 Prognostic Signatures for Estrogen Receptor–Positive Breast Cancer: A Secondary Analysis of a Randomized Clinical Trial
  • Molecular Drivers of Oncotype DX, Prosigna, EndoPredict, and the Breast Cancer Index: A TransATAC Study


ONGOING CLINICAL STUDIES

  • EXPERT (Examining
    Personalised Radiation Therapy
    for Low-risk Early Breast
    Cancer) Clinical Trial
  • OPTIMA (Optimal Personalised
    Treatment of early breast cancer using Multi-parameter Analysis) Clinical Trial

COMMERCIAL LABS

Select one of the nationally accessible labs below to learn more about how you can have the Prosigna breast cancer assay performed on the locally available nCounter Analysis System.  

HEALTH INSURANCE COVERAGE

The Prosigna Breast Cancer Assay is covered by Medicare and commercial payers for patients
meeting the indications for use

To learn more about Prosigna Breast Cancer Assay’s commercial coverage please get in touch with our customer care team or email us at info@prosigna.com.

NEWS

  • Veracyte Announces Further European Reimbursement Expansion for Prosigna Breast Cancer Test
  • Veracyte Announces New Consensus Data from PROCURE Study Presented at ESMO Breast Cancer 2022
  • Prosigna Breast Cancer Assay Now Approved for Reimbursement in Germany

VIDEOS

  • Helping patients understand their gene expression profiling (GEP) risk of recurrence scores

    What are the ways to help breast cancer patients understand their risk of recurrence scores? In his webinar, Professor Dame Lesley Fallowfield discusses the successful TARGET educational programme in the UK and the IMPARTER study, which examines if provision of a specific patient information film improves knowledge about gene expression profiling (GEP) and enhances satisfaction with patient-clinician discussions.

    Speaker: Professor Dame Lesley Fallowfield

    • Discuss the TARGET educational programme in the UK
    • Learn about the IMPARTER study
    • Discover patient information films

    *This session is intended for physicians practicing outside of the U.S., however, U.S.-based physician’s are welcome to attend.​

  • What are the advantages of using a second-generation genomic test?
    What are the advantages of using a second-generation genomic test? What is the utility of intrinsic subtyping in the clinic? The past, present and future. Interactive webinar designed for doctors treating breast cancer interested in advancing personalized treatment through molecular gene expression testing.

    Speaker: P. Kelly Marcom, MD | Medical Director-Breast Cancer, Veracyte Understand the potential of Prosignaⓐ

     

    • Discuss the advantages of using a second-generation genomic test
    • Learn about the utility of intrinsic subtyping in the clinic
    • Live discussion and debates looking at the past, present and future.

    *This session is intended for physicians practicing outside of the U.S., however, U.S.-based physician’s are welcome to attend.​

  • The history and evolution of PAM50 & Prosignaⓐ
    The history and evolution of PAM50 & Prosignaⓐ from the laboratory to the clinic: how accurate biological classification can be used to best treat your patients. Live discussion and debates looking at the history and origins of PAM50 and Prosigna and the adoption process in a reference center in Heidelberg, Germany.

    Speakers: Charles M. Perou, PhD, Prof. Torsten O. Nielsen and Dr. phil. Martina Kirchner

     

    • Understand the history and origin of PAM50 & Prosigna
    • Discuss their evolution from the laboratory to the clinic
    • Learn how accurate biological classification can be used to best treat your patients

    *This session is intended for physicians practicing outside of the U.S., however, U.S.-based physician’s are welcome to attend.​

  • Differences between 1st and 2nd generation gene expression profile tests: which perform best and why?
    How do you do a direct comparison of prognostic performance across multiple molecular gene expression assays? To learn more, we invite you to watch this presentation of Dr. Ivana Sestak at SFSPM 2021 on molecular gene expression assays used to guide treatment of HR+ early-stage cancer. (English)

    *This session is intended for physicians practicing outside of the U.S., however, U.S.-based physician’s are welcome to attend.​

  • Association of Breast Surgery (ABS) - Veracyte Sponsored Event
    We invite you to watch this panel discussion and case study presentation on the Prosigna® Breast Cancer Prognostic Gene Signature Assay with:
    • Professor Mark Beresford – Clinical Oncologist
    • Dr Marina Parton – Medical Oncologist
    • Dr Judy King – Medical Oncologist
    • Professor Abeer Shaaban – Breast Pathologist
    • Mr James Harvey – Breast Surgeon

    *This session is intended for physicians practicing outside of the U.S., however, U.S.-based physician’s are welcome to attend.​