Agendia, Inc., a world leader in precision oncology, today announced the presentation of study results for BluePrint and MammaPrint use in identifying African-American women with hormone receptor positive tumors that have different genomic subtypes and risk than Caucasian women. The study suggests that BluePrint and MammaPrint can help characterize a tumor’s biology -- a critical component of treatment decision-making -- and the prognosis that select patients may have, whether low or high risk, independent of genetic ancestry.

African-American women with breast cancer typically have a less favorable prognosis overall. This is a result of numerous factors including well-established health disparities, as well as differences in tumor biology. MammaPrint is a prognostic and predictive diagnostic test for early stage breast cancer that analyzes the 70 most important genes associated with cancer recurrence to classify each breast cancer patient into "low risk" or "high risk" of developing metastases within the first 10 years after diagnosis.

 Presented today, results from the study "Race and response to neoadjuvant chemotherapy according to MammaPrint risk" showed:

African-American patients had a higher likelihood of having higher grade, ER-, LN+ tumors

MammaPrint identified patients with low risk outcomes, irrespective of race

In multivariate analysis, race was a significant factor for higher pathological complete response (pCR) rates to neoadjuvant chemotherapy in African-American compared to Caucasian patients, together with PR, HER2, T-stage and Grade (HR = 1.679, 95% CI = (1.057, 2.67), p = 0.028)

"The findings in this study add important new observations to the prior research with MammaPrint regarding the biologic characteristics of breast cancer in African-American women. Molecular subtyping with BluePrint in African-American women, compared with Caucasian women, found different proportions of Luminal A, Luminal B, HER2 and Basal type cancers. Most importantly however, MammaPrint identification of Low or High Risk outcomes and Blueprint ability to classify subtypes were the same, regardless of African-American or Caucasian ancestry. Unlike other assays, MammaPrint and BluePrint identify critical aspects of tumor biology with universal application and consistent interpretation for all women with breast cancer. These data show that through genomic profiling, we now have the ability to predict and identify how a tumor might respond to treatment to drive better outcomes for all patients with breast cancer," added William Audeh, MD, Medical Oncologist and Agendia Chief Medical Officer.

 A previous study -- the Neoadjuvant BReast Cancer Symphony Trial (NBRST) -- was a prospective trial that showed an association of MammaPrint and BluePrint® with a rate of 2% pCR in Luminal A cancers with a 95% Distant Metastasis Free Interval at 3 years. This new study provides data on the risk distribution, response to therapy, and outcomes in African-American and Caucasian women. The study also confirms that racial differences in gene expression is a contributing factor to the survival disparity observed between African-American and Caucasian women with breast cancer.

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 within 5 years. The test is performed for breast cancer patients, with Stage I or Stage II disease, with tumor size ≤ 5.0 cm and lymph node negative. 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. MammaPrint is the only test of its kind recommended for lymph node-negative and lymph node-positive patients by both the American Society of Clinical Oncology (ASCO) and National Comprehensive Cancer Network (NCCN®). The test is also recommended by many other national and international clinical practice guidelines.

About BluePrint®
BluePrint is an 80-gene complementary gene expression 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 focused in breast cancer 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.

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