Partnership will enable women in Singapore, Malaysia, Vietnam, Brunei and Myanmar to access the benefits of MammaPrint® and BluePrint® to personalize treatment management decisions for early breast cancer
Irvine, CA, USA and Amsterdam, the Netherlands , May 24, 2018 / B3C newswire / -- Agendia, Inc., a world leader in personalized medicine and molecular cancer diagnostics, and Angsana Molecular & Diagnostics Laboratory Pte Ltd, a subsidiary of Parkway Pantai, announce a partnership to market the MammaPrint® Breast Cancer Risk of Recurrence test and the BluePrint® Molecular Subtyping test to physicians across Southeast Asia, including Singapore, Malaysia, Vietnam, Brunei and Myanmar.
In total, almost 25,000 women in these markets will be diagnosed with breast cancer each year (1). Under the terms of the agreement, physicians in these markets can now send their patients’ samples, via Angsana, for testing at Agendia’s CLIA-certified and CAP-accredited laboratory in Irvine, California.
MammaPrint analyzes 70 genes most associated with breast cancer recurrence and provides a binary result to identify women with early-stage breast cancer who are at a genomic Low or High Risk for distant metastasis within five years. BluePrint analyzes 80-genes which classify breast cancer into functional molecular subtypes, each with marked differences in long-term outcome and response to neoadjuvant chemotherapy.
These tests provide essential information to aid physicians in making informed and personalized treatment management decisions which can reduce the risk of potential overtreatment and the associated side effects to provide the best outcome for that patient.
Chris Barbazette, Chief Commercial Officer at Agendia said: “South East Asia represents a significant growth opportunity for Agendia and a commercial priority for the Company. With their extensive experience in molecular diagnostics and regional insight, Angsana is an ideal partner as we continue to build our presence in this rapidly-evolving market. We are seeing increasingly more physicians and patients in these countries recognizing the clinical utility of gene expression testing in tailoring the treatment management of breast cancer. Working with Angsana we can most effectively serve these requests, improving access to the practice-changing benefits of the MammaPrint and BluePrint tests.”
Dr Daniel Tan, Chief Executive Officer, Angsana Molecular & Diagnostics Laboratory said: "Breast cancer makes up almost one-third of all cancers diagnosed among women in Singapore and Malaysia. Importantly, more than two-thirds of these cases are discovered at an early stage, where survival rates are significantly higher. MammaPrint helps to empower these early stage breast cancer patients by providing extra genomic information, enabling them and their oncologists to make informed, confident decisions about their treatment, and avoiding the side-effects of unnecessary chemotherapy. The test can also help to reduce the patient’s overall treatment costs, making valuable medical resources available for other patients.”
The scale of the potential quality of life and cost-effectiveness benefits of MammaPrint were demonstrated in the landmark MINDACT trial published in 2016. MINDACT found that almost 50 percent of patients initially identified as at high risk of their cancer recurring using clinical and pathological factors and therefore candidates for chemotherapy, were in fact low risk according to the MammaPrint test and unlikely to benefit from it (2).
Based on a review of the findings of this trial, the American Society of Clinical Oncology (ASCO) published a dedicated update to its breast cancer clinical practice guidelines in July 2017 (3). It named MammaPrint as the only test of its kind recommended to inform treatment decisions for both lymph node-positive and lymph node-negative breast cancer patients. MammaPrint is also included in other important international oncology practice guidelines including the European Society for Medical Oncology (ESMO), the St. Gallen Breast Cancer Consensus.
MammaPrint is an in vitro diagnostic medical device, performed as a testing service in a central laboratory, using the gene expression profile of breast cancer tissue samples to assess a patients’ risk for distant metastasis. The device is FDA-cleared and CE-marked, enabling use in the European Union. 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.
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.
MINDACT is a prospective, randomized, phase III, controlled clinical trial that investigated the clinical utility of MammaPrint, when used in conjunction with standard clinical pathological criteria, for the selection of patients unlikely to benefit from adjuvant chemotherapy. From 2007 to 2011, 6,693 women who had undergone surgery for early-stage breast cancer were enrolled in the trial, across 112 centers in nine countries.
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 the MammaPrint® 70-Gene Breast Cancer Risk-of-Recurrence Test, and the BluePrint® Molecular Subtyping Test, both on microarray technology, and the new MammaPrint BluePrint Recurrence and Molecular Subtyping test, on NGS technology.
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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About Angsana Molecular & Diagnostics
Angsana is a multinational molecular and diagnostics company headquartered in Singapore, with offices in Hong Kong and Malaysia. Established in 2014 and a subsidiary of Parkway Pantai, Angsana specialises in developing premium genomic assays in molecular oncology, fetal maternal health, allergy & molecular allergology and pharmacogenomics, areas that have the largest impact on the Asian population. Angsana not only provides clinicians with the analysis of medical conditions at a molecular level but also consultation on the diagnosis and empower them with personalised medical treatment. Angsana’s laboratory facilities are certified by the College of American Pathologists (CAP), the world’s largest association composed exclusively of pathologists certified by the American Board of Pathalogy. CAP accreditation is internationally recognised as the ‘gold standard’ for clinical laboratories.
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(1) M. Ervik, F. Lam, J. Ferlay, L. Mery, I. Soerjomataram, F. Bray (2016). Cancer Today. Lyon, France: International Agency for Research on Cancer. Cancer Today. Available from: http://gco.iarc.fr/today, accessed 21 May 2018.
(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) Krop I, Ismaila N, Andre F et al. Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women With Early-Stage Invasive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline Focused Update. DOI: 10.1200/JCO.2017.74.0472 Journal of Clinical Oncology – published online before print July 10, 2017