Agendia and Genecast Biotechnology Partner to Launch MammaPrint® and BluePrint® in China

IRVINE, Calif. and AMSTERDAM and BEIJING, Sept. 18, 2018 /PRNewswire/ -- Agendia, Inc., a world leader in precision oncology, announced that it has entered into an exclusive commercial partnership with Genecast Biotechnology Co., a Beijing-based cancer testing and diagnostics company, to offer the MammaPrint® and BluePrint® breast cancer risk of recurrence and molecular subtyping tests to patients and their physicians in China for the first time. Under the terms of the agreement, Genecast will hold exclusive marketing and access rights to offer MammaPrint and BluePrint testing in China.

Agendia and Genecast will co-present key data supporting the MammaPrint and BluePrint tests at a satellite symposium during the Chinese Society of Clinical Oncology (CSCO) Annual Meeting on Friday 21 September at 5:30 PM Beijing time, entitled "Breast Cancer Precision Medicine Symposium." Speakers will include Dr. Zefei Jiang, Director of Breast Cancer, Chief Physician and Professor at the Affiliated Hospital of Academy of Military Medical Sciences and Dr. Shu Wang, Director of Breast Disease Center and Professor of General Surgery at Peking University People's Hospital.

Breast cancer is the most common cancer among women in China with roughly 300,000 women diagnosed each year.¹ This number is expected to increase as screening methods improve and a greater percentage of the population gains access to these tools, leading to more cancers detected at an early stage.³ At launch later this year, physicians will be able to send their patients' samples to Genecast's specialty oncology laboratory for MammaPrint and BluePrint testing.

MammaPrint and BluePrint provide essential genomic information which, when added to clinical factors such as age, tumor size and hormone receptor status, help physicians make informed treatment management decisions, reducing the risk of potential overtreatment and the associated side effects to provide the best outcome for each patient. This has significant quality of life and cost-effectiveness benefits for patients and for reducing healthcare spend on a national scale.

Dr. Franklin Libenson, Senior Vice President Strategic Marketing and Market Development at Agendia, said:

"China is a significant market with an urgent need for tests like MammaPrint and BluePrint which can be performed domestically and are backed by both the highest level of clinical evidence (Level 1A) and prestigious international breast cancer treatment guidelines. We believe that patients should have access to the precision answers our tests provide and, in partnering with Genecast, we are now able to be the first to offer them to women with breast cancer and their care team in China."

Du Bo, Co-Founder and CEO at Genecast, said:

"At Genecast, we are dedicated to improving cancer treatment through precision cancer diagnostics. We recognize the value of MammaPrint and BluePrint in enabling a unique, personalized approach to treating early-stage breast cancer and are very pleased to deliver these tests in China. Cancer is fundamentally a genomic disease, by applying cutting-edge tools that analyze the genes of a person's tumor we can better understand it and act more effectively to prevent over and under treatment."

Agendia's MammaPrint test analyzes 70 genes most associated with breast cancer recurrence to provide a clear, binary Low or High Risk of distant recurrence result, while BluePrint analyzes 80 genes, which classify a patient's breast cancer into functional molecular subtypes.

The landmark MINDACT trial, published in the New England Journal of Medicine in 2016, found that almost 50 percent of patients initially identified with a high risk of their cancer recurring based on clinical and pathological factors and thus candidates for chemotherapy, were in fact low risk according to the MammaPrint test and unlikely to benefit from it.² The results of the MINDACT trial have the potential to spare more than 100,000 women annually⁴ with early-stage breast cancer worldwide from unnecessary toxicities and side effects from chemotherapy as well as creating considerable cost savings.

¹ Zuo T, Zheng R, Zeng H, Zhang S, Chen W. Female breast cancer incidence and mortality in China, 2013. Thoracic Cancer. 2017;8(3):214-218. doi:10.1111/1759-7714.12426.
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 Wanqing Chen, Rongshou Zheng, et al. Cancer Statistics in China, 2015, CA CANCER J CLIN 2016;66:115–132
⁴ Based on applying MINDACT risk data to: American Cancer Society. Global Cancer Facts & Figures 3rd Edition. Atlanta: American Cancer Society; 2015. (online) and American Cancer Society. Breast Cancer Facts & Figures 2015-2016. Atlanta: American Cancer Society, Inc. 2015.

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. 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.

About BluePrint
BluePrint is an 80-gene complementary laboratory-developed 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, 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. Follow Agendia, Inc. on Facebook, Twitter, or LinkedIn to keep up-to-date with the latest news.

About Genecast Biotechnology
Genecast (Beijing) Biotechnology Co. is a privately held leading precision oncology company in China. We offer well validated clinical tests to cancer patients and clinicians based on multiple technology platforms including NGS, IHC, ddPCR, microarray, etc. We are dedicated to providing patients and clinicians individualized cancer diagnosis and treatment to improve their survival and quality of life.

In addition, by leveraging our multifaceted technical approach, we actively collaborate with leading domestic and international pharmaceutical and biotech companies to develop and validate oncology biomarkers for clinical trials, treatment and companion diagnosis.
www.genecast.com.cn

Media Contacts
Agendia
Weber Shandwick
Heather Platisha
+1 (206) 576-5558
[email protected]

Genecast Biotechnology
Dan Chen
+(86) 134-3979-5181
[email protected]

SOURCE Agendia, Inc.

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