Agendia Announces New Research Reinforcing MammaPrint® and BluePrint® Testing to Guide Breast Cancer Treatment Management Decisions Across Different Patient Populations and Ages at the 2018 San Antonio Breast Cancer Symposium

IRVINE, CA, AMSTERDAM, NETHERLANDS – 28 November 2018 – Agendia, Inc., a world leader in precision oncology, will present new data reinforcing the utility of its MammaPrint® 70-Gene Breast Cancer Risk of Recurrence and BluePrint® Breast Cancer Molecular Subtyping tests at the 2018 San Antonio Breast Cancer Symposium (SABCS). A total of 14 posters and discussions are being presented at SABCS, which will take place at the Henry B. Gonzales Convention Center in San Antonio, Texas from Dec. 4-8, 2018.

Data outlining the cost-effectiveness and economic impact of MammaPrint, as well as performance data of MammaPrint and BluePrint in real-world diagnostic and decentralized testing settings across different patient populations, including HER2-positive cancer and those affected by metabolic syndrome, will be presented.

A highlight will be the poster session on Friday, Dec. 7, which will show that MammaPrint reclassifies 46 percent of patients aged 50 or younger with intermediate recurrence scores (RS 18-30) according to the 21-gene assay as MammaPrint Low Risk, suggesting they are unlikely to benefit from chemotherapy.

Important data from the following studies will also be presented:

  • I-SPY 2 (Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer)
  • FLEX (MammaPrint, BluePrint, and Full-genome Data Linked With Clinical Data to Evaluate New Gene EXpression Profile)
  • PROMIS (Prospective Study of MammaPrint in Breast Cancer Patients with an Intermediate Recurrence Score)
  • IMPACt (Measuring the Impact of MammaPrint on Adjuvant and Neoadjuvant Treatment in Breast Cancer Patients: A Prospective Registry)
  • MINT (Multi-Institutional Neoadjuvant Therapy MammaPrint Project I) trials

Dr. William Audeh, Chief Medical Officer at Agendia, said:

“The wealth of new clinical and genomic data presented at SABCS adds to an already significant body of evidence supporting the use of MammaPrint and BluePrint to help physicians and breast cancer patients around the world make informed treatment decisions.

“As these new data will show, MammaPrint and BluePrint continue to offer expanded utility for patients of all ages, whether lymph node-negative or lymph node-positive, with lobular cancer, in neoadjuvant therapy and across different technologies. Of particular interest will be the unique genomic data in cancers identified as HER2 “equivocal” by pathology. The use of MammaPrint and BluePrint in breakthrough trials such as I-SPY 2, which will also report new data at SABCS, is testament to the quality and robustness of the science that underpins these tests. It is becoming increasingly clear that genomic testing offers a path to more personalized medicine in breast cancer, and we are proud that our tests are at the forefront of this effort.”

Abstracts are available to view on the SABCS website.  For more information please visit the Agendia team at booth #607.

Wednesday, Dec. 5

  • Poster OT1-13-01: MammaPrint, BluePrint, and full-genome data linked with clinical data to evaluate new gene expression profiles (FLEX); Hall 1, 5:00 – 7:00 PM CST; Ongoing Clinical Trials.
  • Poster P1-15-07: Phase II trial of neoadjuvant carboplatin and nab-paclitaxel in patients with locally advanced triple negative breast cancer; Hall 1, 5:00 – 7:00 PM CST; Poster Session 1.

Thursday, Dec. 6

  • Poster P3-10-22: BluePrint molecular subtyping versus HER2 assessment by immunohistochemistry and FISH in the real-world diagnostic setting; Hall 1, 5:00 PM-7:00 PM CST; Poster Session 3.
  • Poster P3-10-02: Identifying breast cancer molecular phenotypes to predict response in a modern treatment landscape: Lessons from ~1000 patients across 10 arms of the I-SPY 2 TRIAL; Hall 1, 5:00 PM-7:00 PM CST; Poster Session 3.
  • Poster P3-10-06: Expression-based immune signatures as predictors of neoadjuvant targeted-/chemo-therapy response: Experience from the I-SPY 2 TRIAL of ~1000 patients across 10 therapies; Hall 1, 5:00 PM-7:00 PM CST; Poster Session 3.
  • Poster P3-10-13: LIV-1 expression in primary breast cancers in the I-SPY 2 TRIAL; Hall 1, 5:00 PM-7:00 PM CST; Poster Session 3.

Friday, Dec. 7

  • Poster Discussion PD7-04: Metabolic syndrome increases risk of recurrence and impacts immune pathways in invasive lobular carcinoma; Stars at Night Ballroom 1 & 2, 07:00 – 09:00 AM CST. Spotlight Session: Lobular Breast Cancer.
  • Poster Discussion PD7-06: Molecular subtypes of invasive lobular breast cancer in the I-SPY2 TRIAL; Stars at Night Ballroom 1 & 2, 07:00 – 09:00 AM CST. Spotlight Session: Lobular Breast Cancer.
  • Poster Discussion PD8-04: Neoadjuvant chemotherapy for breast cancer: Nodal downstaging is highly correlated with pathological complete response; Stars at Night Ballroom 3 & 4, 07:00 – 09:00 AM CST. Spotlight Session: Local Regional Therapy.
  • Poster P4-02-07: Comparison of breast cancer molecular subtyping by Immunohistochemistry and by BluePrint® next generation RNA sequencing-based test at University Hospitals Leuven and Curie Institute Paris; Hall 1, 07:30 – 09:00 AM CST; Poster Session 4.
  • Poster P4-08-10: MammaPrint identifies 46% of patients, age ≤50 years with oncotype RS 18-30, as low risk and safe to forgo chemotherapy; Hall 1, 07:30 – 09:00 AM CST; Poster Session 4.
  • Poster P4-08-12: Comparative analyses of the prognostic value of oncotype and mammaprint using the National Cancer Database; Hall 1, 07:30 – 09:00 AM CST; Poster Session 4.
  • Poster P4-08-25: Decentralized beta testing of MammaPrint and BluePrint NGS kit at University Hospitals Leuven and Curie Institute Paris; Hall 1, 07:30 – 09:00 AM CST; Poster Session 4.
  • Poster P5-15-08: Economic Impact of MammaPrint (70-gene signature) in a clinical high risk population: A 10yr Markov model, 6,000-patient retrospective analysis of US claim data; Hall 1, 05:00 – 06:00 PM CST; Poster Session 5.

About MammaPrint®

MammaPrint is an in vitro diagnostic medical device, performed as a testing service in a central laboratory, using the 70-gene expression profile of breast cancer tissue samples to assess a patient’s risk for distant metastasis. The device is FDA-cleared and CE-marked, enabling use in the European Union. MammaPrint is indicated for use by physicians as a prognostic marker only, along with other clinical-pathological factors. It is not intended to determine the outcome of disease, nor to suggest or infer an individual patient’s response to therapy.

About BluePrint®

BluePrint is an 80-gene complementary test provided with MammaPrint which allows functional molecular subtyping of a breast cancer sample into three distinct subtypes: Luminal-type, HER2-type and Basal-type, each with marked differences in long-term outcome and response to neoadjuvant chemotherapy.

About Agendia

Agendia is a privately held, leading precision oncology company that develops and markets genomic diagnostic products, which help support physicians with their complex treatment decisions. Agendia’s breast cancer tests were developed using an unbiased gene selection by analyzing the complete human genome. The company’s offerings include the MammaPrint Breast Cancer Risk-of-Recurrence Test, and the BluePrint Molecular Subtyping Test, both on microarray technology, whereas the new MammaPrint BluePrint Breast Cancer Recurrence and Molecular Subtyping Kit, is on NGS technology.

The MammaPrint BluePrint next-generation sequencing-based kit is a CE-marked device currently available for use in cancer centers in select regions of the world.

In addition, Agendia has a pipeline of other genomic products in development. The company collaborates with pharmaceutical companies, leading cancer centers and academic groups to develop companion diagnostic tests in the area of oncology. For more information on Agendia or the MammaPrint and BluePrint tests, visit Follow Agendia, Inc. on Facebook, Twitter, or LinkedIn to keep up-to-date with the latest news.

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