Agendia Genomic Tests (MammaPrint, BluePrint & TargetPrint) Among Highlights of San Antonio Breast Cancer Symposium

Publication Name: Press Release

Podium Presentations and Ten Scientific Posters Focus Cancer MDs’ Attention on Second-Generation Symphony Suite for Recurrence Risk and Molecular Subtyping

IRVINE, CA and AMSTERDAM, THE NETHERLANDS, December 23, 2013 – Agendia’s innovations in genomic testing for breast cancer were among highlights of the recently concluded San Antonio Breast Cancer Symposium (SABCS). The conference, which drew about 7,500 attendees from more than 90 countries, featured two podium presentations with information about Agendia’s tests, plus 10 scientific posters reporting new research on the company’s second-generation Symphony® Suite of genomic tests (MammaPrint®, BluePrint® and TargetPrint®).

MammaPrint provides definitive High Risk or Low Risk information about early-stage breast cancer recurrence, with no “intermediate” results. Symphony is the only widely available test suite for breast cancer that provides molecular subtyping — a recent advancement in prognosis and treatment that was highlighted in several SABCS posters.

“One lesson to draw from this conference is that a growing number of breast cancer specialists recognize the value of these personalized genomic tests and are using them with more and more patients,” said Stephen Gluck, M.D., Ph.D. “These tests are shifting the paradigm of prognosis and treatment. They provide additional personalized information about the likelihood that a woman’s breast cancer will recur, along with better guidance about the molecular subtype of the cancer and how best to treat to it.” At SABCS, Dr. Gluck detailed his research for a select group of oncology key opinion leaders. He is the Sylvester Professor in the Department of Medicine, Division of Hematology/Oncology, Sylvester Comprehensive Cancer Center at the University of Miami, Leonard M. Miller School of Medicine.

Among the podium presentations were first efficacy results from the I-SPY II Breast Cancer Clinical Trial, presented by Hope S. Rugo, M.D., Clinical Professor in the Department of Medicine at the UC San Francisco and Director of its Breast Oncology Clinical Trials Program. MammaPrint was selected by academic, government and industry leaders as the biomarker of choice for the I-SPY II Trial — which along with the MINDACT trial makes Agendia the new leader in patient stratification for clinical trials, utilizing MammaPrint for frontline stratification of six approved and five early-stage cancer therapeutics.

Also presenting Symphony-related information from the podium was Laura van ’t Veer, Ph.D., a world renowned molecular biologist, the inventor of MammaPrint and a breast oncology program leader at UCSF. Her talk was titled “Genomics Variation underlying Breast Cancer Heterogeneity.”

Several of the 10 scientific posters about the Symphony tests focused on the advantages of molecular subtyping, including these:

* Researchers reported that MammaPrint and BluePrint are better than traditional, clinical pathology methods at classifying the nature of a woman’s breast cancer, thereby allowing physicians to more precisely tailor each patient’s treatment. The multi-site research was presented by Massimo Cristofanilli, M.D, Director of the Jefferson Breast Care Center at the Kimmel Cancer Center and Thomas Jefferson University and Hospitals, in Philadelphia.

* MammaPrint and BluePrint can better predict how a breast cancer patient will respond to neoadjuvant (pre-surgical) chemotherapy, according to another multi-site poster. “Molecular subtyping assists physicians as they determine whether the side effects endured by the patient are worth the additional benefit gained by chemotherapy,” said presenter Peter Beitsch, M.D., a breast surgeon at Medical City Dallas who is also president of the American Society of Breast Surgeons.

“These multiple presentations conclusively demonstrated Agendia’s leadership in genomic testing for breast cancer,” said David Macdonald, the company’s CEO. “We were also very pleased to see the enormous interest in our tests throughout the San Antonio conference, and the continuing growth in adoption of the Symphony suite of tests.”

MammaPrint is the first FDA-cleared test to determine recurrence risk in breast cancer patients. Symphony is the only predictive, multi-gene breast cancer panel that is based on prospective trials including outcome data (e.g., the RASTER study). The Agendia tests have substantial insurance coverage encompassing an estimated 170 million lives and including coverage by Medicare and regional and national insurers.

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, and TargetPrint®, an ER/PR/HER2 expression assay. Together, these tests help physicians determine a patient’s individual risk for

metastasis, which patients will benefit from chemo, hormonal, or combination therapy, and which patients do not require these treatments and can instead be treated with other less arduous and less costly methods.

In addition to the Symphony suite of tests, Agendia has a rich pipeline of 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 and is a critical partner in the ISPY-2 and MINDACT trials. For more information, visit www.agendia.com.

 

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Liz Dowling (Medical & Consumer Media)

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Matt Clawson or

Len Hall (Financial Media)

Allen & Caron Inc. 949-474-4300

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