IRVINE, CA and AMSTERDAM – 6 July 2017 – Agendia, Inc., a world leader in personalized medicine and molecular cancer diagnostics announces that the 15^th St. Gallen International Breast Cancer Guidelines recently published in Annals of Oncology¹ have recommended the MammaPrint^® 70-Gene Breast Cancer Risk-of-Recurrence Test for the third time to help guide treatment decision-making for patients with early-stage breast cancer.
The 2017 update expands the panel’s consensus on MammaPrint to include its use as a prognostic tool to make treatment decisions for adjuvant (post-surgery) chemotherapy in patients with lymph-node positive breast cancer.
The biennial guidelines noted the MammaPrint test has now been evaluated in a prospective study.  The results of the Microarray In Node-negative and 1 to 3 positive lymph node Disease may Avoid ChemoTherapy (MINDACT) clinical trial, published in August 2016,² provided the prospective data that demonstrated patients with a MammaPrint “low risk result and a limited degree of lymph node involvement appear to have a good prognosis with or without chemotherapy.”  Only one other gene-expression test was recommended for guiding treatment decisions for lymph-node positive patients.
Lymph-node positive patients are often the most likely to be classified at high risk of their cancer recurring using clinical factors like age and tumor size. However, data from the MINDACT trial found that more than 60% of patients were reclassified as genomic Low Risk using MammaPrint, and did not show a significant benefit from chemotherapy.
With the new 2017 St. Gallen guidelines, MammaPrint continues to be recommended to guide adjuvant chemotherapy decisions in patients with tumors with no affected lymph nodes (lymph-node negative) and as a prognostic marker to aid treatment decisions in adjuvant endocrine (hormone) therapy in lymph-node negative patients.
Importantly, the updated St. Gallen guidelines also recommended changes from its prior guidance³ for the 21-gene recurrence score’s cut-off to avoid chemotherapy, which was lowered from RS<25. In intermediate risk patients with a recurrence score from 12-24, it was suggested to consider adding adjuvant chemotherapy.  Similarly, the AJCC (American Joint Committee on Cancer) recently updated its 8^th edition manual only recommending use of the recurrence score <11 as providing sufficient evidence to be included, which only accounts for approximately 16% of breast cancer patients.⁴
The St. Gallen panel, which was made up of 43 of the world’s foremost breast cancer experts from 23 countries⁵ discussed and voted on a series of treatment recommendations for early breast cancer during an open session on the final day of the St. Gallen International Breast Cancer Conference, held in Vienna in March 2017.
Dr. William Audeh, Chief Medical Officer at Agendia, said: “It is very encouraging to see MammaPrint not only included in these prestigious guidelines for a third time, but to see the MammaPrint recommendation expanded to become one of only two gene-expression tests recommended for making treatment decisions for patients with positive lymph-node involvement.
“The landmark MINDACT trial provided the highest possible level of clinical evidence to support the clinical utility of MammaPrint, and the St. Gallen Consensus marks the third set of guidelines this year to recommend the test based on this unique data.”
MammaPrint has been recently recognized as being supported by level 1A clinical evidence by the German Gynecological Oncology Group (AGO) in Germany, the European Group on Tumor Markers (EGTM), and is also recommended for use in other important best-practice guidelines including those of the European Society for Medical Oncology (ESMO).
 
^{1 Curigliano G, Burnstein H, Winer E et al. De-escalating and Escalating Treatments for Early Stage Breast Cancer: The St. Gallen International Expert Consensus Conference on the Primary Therapy of Early Breast Cancer 2017. Ann Oncol 2017 mdx308.
2 Cardoso F, van’t Veer LJ, Bogaerts J et al. 70-Gene Signature as an Aid to Treatment Decisions in Early-Stage Breast Cancer. N Engl J Med 2016; 375: 717-29.
3 Goldhirsch A, Winer E P, Coates A S, et al. Personalizing the treatment of women with early breast cancer: highlights of the St Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2013. Ann Oncol 2013; 24 (9): 2206-2223.
4 American Joint Committee on Cancer 2017. M.B.Amin et al. (eds.) AJCC Cancer Staging Manual, 8th Edition.
5 Gnant M, Harbeck N, Thomssen C. St. Gallen/Vienna 2017: A Brief Summary of the Consensus Discussion about Escalation and De-Escalation of Primary Breast Cancer Treatment. Breast Care 2017;12:102–107.}
 
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About MammaPrint
MammaPrint is an in vitro diagnostic test, performed in a central laboratory, using the gene expression profile of breast cancer tissue samples to assess a patients’ risk for distant metastasis. MammaPrint is cleared by the US FDA and carries the CE Mark which certifies that the test complies with the quality standards set by the European In Vitro Diagnostic Directive, enabling the use of the test in the European Union.  MammaPrint is indicated for use by physicians as a prognostic marker only, along with other clinical-pathological factors.  The test is not intended to determine the outcome of disease, nor to suggest or infer an individual patient’s response to therapy.
About Agendia
Agendia is a privately held, leading molecular diagnostics 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.  Our offerings include MammaPrint^®, a 70-Gene Breast Cancer Risk-of-Recurrence test, and BluePrint^®, a Molecular Subtyping Assay that provides deeper insight leading to more clinically actionable breast cancer biology.
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, you can visit Agendia’s patient site at www.KnowYourBreastCancer.com or the corporate site at www.agendia.com.
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