Foundation Medicine, Roche and DIAN Diagnostics Collaborate to Advance Personalized Cancer Care in China

CAMBRIDGE, Mass.

Foundation Medicine, Inc., (NASDAQ:FMI), F. Hoffmann-La Roche Ltd (Roche) and DIAN Diagnostics Group, Co., Ltd. (DIAN), today announced a three-party collaboration to integrate Foundation Medicine’s comprehensive genomic profiling (CGP) assays into clinical patient care in mainland China. Under the collaboration:

• DIAN, a leader in the development and supply of Chinese medical diagnostic products and services, becomes the exclusive clinical sequencing partner in China for FoundationOne®, FoundationACT® and FoundationOne®Heme, enabling the delivery of personalized cancer care for patients.
• Roche maintains commercial exclusivity for Foundation Medicine’s molecular information products in China, and in cooperation with DIAN continues its current in-county activities to support the broad integration of CGP into clinical care.

Cancer is the leading cause of death among China’s population of 1.4 billion. In 2015, there were approximately 4.3 million new cancer cases and more than 2.8 million cancer deaths in China¹. Given the high volume of new and emerging oncology research, new innovations in diagnostics and the country’s national focus on personalized care, there is a need for molecular information services that enable oncologists to efficiently match patients to cancer therapies based on the molecular blueprint of each individual’s tumor.

“Healthcare is transforming at a rapid pace in China and there is a national urgency to develop strategies that can advance personalized medicine to improve clinical outcomes for patients,” said Mr. Haibin Chan, Chairman of DIAN Diagnostics. “The integration of analytically-validated CGP tests into clinical practice is critical to inform patient treatment options, including determining eligibility for many clinical trials. We believe the combination of DIAN’s diagnostics expertise and market leadership, Roche’s commercial expertise, paired with Foundation Medicine’s leadership in molecular information, will assist China in taking a significant step forward toward achieving its national goal of widespread patient access to precision medicine.”

DIAN is one of the leading independent medical laboratories in China and is dedicated to innovation in diagnostic testing platforms. Importantly, DIAN is one of the first commercial laboratories approved by the National Health Commission of China to receive a next generation sequencing (NGS) pilot license for cancer diagnostics. DIAN’s diagnostic network stretches to more than 30 laboratories, covering almost all of mainland China, processing more than 100,000 clinical samples per day. To advance clinical diagnostics in China, DIAN has also established “precision treatment centers” with medical institutions and hospitals.

“DIAN’s sequencing expertise and its broad healthcare network will enable CGP as a critical component of patient clinical care in China,” stated Melanie Nallicheri, chief business officer and head, biopharma for Foundation Medicine. “Accelerating patient access to precision medicine approaches is critical to China’s oncology community and we’re delighted that our participation in this effort supports Foundation Medicine’s presence, differentiation and patient impact globally.”

About Foundation Medicine

Foundation Medicine (NASDAQ:FMI) is a molecular information company dedicated to a transformation in cancer care in which treatment is informed by a deep understanding of the genomic changes that contribute to each patient’s unique cancer. The company offers a full suite of comprehensive genomic profiling assays to identify the molecular alterations in a patient’s cancer and match them with relevant targeted therapies, immunotherapies and clinical trials. Foundation Medicine’s molecular information platform aims to improve day-to-day care for patients by serving the needs of clinicians, academic researchers and drug developers to help advance the science of molecular medicine in cancer. For more information, please visit http://www.FoundationMedicine.com or follow Foundation Medicine on Twitter (@FoundationATCG).

About DIAN

DIAN Diagnostics Group Co., Ltd. is one of the leading diagnostic companies in China, focusing on the business of independent clinical diagnosis service. DIAN’s diagnostic network in China stretches to more than 38 laboratories, covering every province of mainland China. DIAN is serving more than 15,000 medical institutions in China.

DIAN is committed to providing a “Total Solution of Medical Diagnosis Service” for its customers, with the business segment covering medical diagnosis services, IVD products, cold-chain logistics, forensic expertise, CRO business and other medical diagnostic related fields. With the mission of “Equal Access to Healthcare”, DIAN is committed to create a health industrial eco system and achieve multiple-wins for medical institutions, government and people.

Foundation Medicine^®, FoundationOne^®, FoundationACT^® and FoundationOne^®Heme are registered trademarks of Foundation Medicine, Inc.

Cautionary Note Regarding Forward-Looking Statements for Foundation Medicine

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding a collaboration among Foundation Medicine, Roche, and DIAN; the ability of the collaboration to accelerate the integration of Foundation Medicine’s CGP assays into clinical care of patients or patient access to precision medicine in China; and the ability of the collaboration to expand Foundation Medicine’s presence, differentiation and patient impact globally. All such forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include the risk that the parties are unable to successfully implement the collaboration and commercialize Foundation Medicine’s CGP assays in China; the risk that the collaboration does not proceed as expected; the risk that the collaboration does not meet the objectives of the parties; and the risks described under the caption “Risk Factors” in Foundation Medicine’s Annual Report on Form 10-K for the year ended December 31, 2017, filed with the Securities and Exchange Commission on March 7, 2018, as well as other risks detailed in Foundation Medicine’s subsequent filings with the Securities and Exchange Commission. All information in this news release is as of the date of the release, and Foundation Medicine undertakes no duty to update this information unless required by law.

¹ W. Chen et al., CA Cancer J. Clin. 66, 115–132 (2016).

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