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Blog Exposure - Foundation Medicine Collaborated with Chugai for Commercialization of FoundationOne CDx(TM) in Japan

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LONDON, UK / ACCESSWIRE / March 20, 2018 /Active-Investors.com has just released a free research report on Foundation Medicine, Inc. (NASDAQ: FMI). If you want access to this report all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=FMI as the Company's latest news hit the wire. On March 16, 2018, the Company announced that it has inked a partnership deal with Chugai Pharmaceutical Co., Ltd (''Chugai''), a member of the Roche Group, to broaden patient access to Foundation Medicine's comprehensive genomic profiling (CGP) services for individuals with advanced cancer in Japan. Register today and get access to over 1,000 Free Research Reports by joining our site below:


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Details of the Agreement

Chugai has filed for regulatory approval of FoundationOne CDx™, Foundation Medicine's comprehensive genomic profiling assay for all solid tumors that incorporates multiple companion diagnostics, from the Ministry of Health, Labor, and Welfare (MHLW) in Japan. If approved, FoundationOne CDx™ would get access to MHLW-approved targeted therapies and immunotherapies, as well as clinical trials, for patients with cancer in Japan.

Chugai will be the Marketing Authorization Holder of FoundationOne CDx™ in Japan and will lead commercial efforts in Japan for Foundation Medicine's suite of CGP assays. As per the terms of the agreement, Chugai will pay an upfront fee to Roche.

FoundationOne CDx Approval in Japan is Important for Integration of Comprehensive Genomic Profiling into Oncology Clinical Care

Melanie Nallicheri, Chief Business Officer and Head of biopharma for Foundation Medicine, stated that seeking approval for FoundationOne CDx™ in Japan is an important step for the integration of comprehensive genomic profiling into oncology clinical care.

Melanie also mentioned that an MHLW-approved assay could enable the same accelerated pathway for companion diagnostic development and approval that Foundation Medicine has pioneered in the United States with FDA approval.

The Collaboration Further Enables Chugai to Pursue Personalized Oncology Care in Japan

Tatsuro Kosaka, President and Chief Operating Officer of Chugai, stated that the Company is committed to contributing to healthcare and patients by developing Foundation Medicine's products in the Japanese market. Chugai will also accelerate R&D activities based on PHC by utilizing Foundation Medicine's molecular information platform.

Tatsuro added that this collaboration further enables Chugai to pursue personalized oncology care in Japan.

FDA Approved FoundationOne CDx as a Tumor Mutation Profiling Assay for Patients with Solid Tumors

In November 2017, the US Food and Drug Administration (FDA) approved FoundationOne CDx™. FoundationOne CDx™ is intended for use by health care professionals to help inform cancer treatment management in accordance with professional guidelines for patients with solid tumors. It is the first and only FDA-approved test of its kind for all solid tumors. Concurrent with FDA approval, the Centers for Medicare and Medicaid Services (CMS) issued a preliminary National Coverage Determination (NCD) for FoundationOne CDx™.

About FoundationOne CDx

FoundationOne CDx™ is a next-generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations, and copy number alterations in 324 genes and select gene rearrangements as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffinembedded (FFPE) tumor tissue specimens. FoundationOne CDx™ is intended to be used as a comprehensive companion diagnostic for patients with certain types of cancers.

About Foundation Medicine, Inc.

Founded in 2010 and headquartered in Cambridge, Massachusetts, Foundation Medicine 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. In 2015, Roche and Foundation Medicine entered into a broad strategic collaboration in the field of oncology molecular information.

About Chugai Pharmaceutical Co., Ltd

Chugai is one of Japan's leading research-based pharmaceutical companies focused on early stage clinical research, mainly in the disease areas of oncology, renal disease, and bone and joint disease. Chugai works in strategic alliance with Roche to pursue cutting-edge biopharmaceutical, antibody, and molecular-targeted research technologies-areas.

Stock Performance Snapshot

March 19, 2018 - At Monday's closing bell, Foundation Medicine's stock climbed 1.19%, ending the trading session at $80.80.

Volume traded for the day: 563.76 thousand shares, which was above the 3-month average volume of 293.97 thousand shares.

Stock performance in the last month - up 17.19%; previous three-month period - up 36.03%; past twelve-month period - up 149.00%; and year-to-date - up 18.48%

After yesterday's close, Foundation Medicine's market cap was at $2.88 billion.

The stock is part of the Healthcare sector, categorized under the Medical Laboratories & Research industry.


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