reports
1 director sold
A director at Foundation Medicine Inc sold 73,173 shares at 137.000USD and the significance rating of the trade was 100/100. Is that information sufficient for you to make an investment decision? This report gives details of those trades and adds context and analysis to them such that you can judge whether these trading decisions are ones worth following. Included in the report is a detailed share price chart which plots discretionary trades by all the company's directors over the last two...
Foundation Medicine Announces 2018 First Quarter Results and Recent Hi...
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Foundation Medicine (NASDAQ:FMI) today reported financial and operational results for the first quarter ended March 31, 2018. Highlights for the quarter included: Posted revenue of $52.8 million, 101% year-over-year growth; Reported 21,861 clinical tests, 57% year-over-year growth; Achieved broad Medicare coverage through a final National Coverage Determination (NCD) from the Centers for Medicare and Medicaid Services (CMS) for FoundationOne...
Foundation Medicine Launches Gene Expression Profiling Program to Iden...
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Foundation Medicine, Inc. (NASDAQ:FMI) today announced a comprehensive gene expression profiling (GEP) program to support precision oncology clinical research and development. This initiative, which provides a natural complement to Foundation Medicine’s comprehensive genomic profiling (CGP) suite of molecular information tests, further enhances support for the Company’s biopharma partners in the efficient identification of known and novel genomic and expression-based biomarkers of response fo...
Foundation Medicine, Roche and DIAN Diagnostics Collaborate to Advance...
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- 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...
Foundation Medicine’s New Liquid Biopsy Assay Granted Breakthrough D...
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Foundation Medicine, Inc. (NASDAQ:FMI) today announced that the U.S. Food and Drug Administration (FDA) granted a Breakthrough Device designation (formerly Expedited Access Pathway program) for its new liquid biopsy assay, which is an expanded version of its FoundationACT® assay. The new assay will include more than 70 genes and genomic biomarkers for microsatellite instability (MSI) and blood tumor mutational burden (bTMB). If approved, this test could be the first FDA-approved liquid biopsy...
Foundation Medicine Announces Timing for First Quarter 2018 Financial ...
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Foundation Medicine, Inc. (NASDAQ:FMI) today announced that financial results for the company's first quarter ended March 31, 2018 will be released on Wednesday, May 2, 2018. The management team will host a conference call on Wednesday, May 2, 2018, at 4:30 p.m. ET to discuss the company's financial results and recent developments. The call can be accessed by dialing 1-844-784-1732 (domestic) or 1-412-902-6714 (international) five minutes prior to the start of the call. A passcode is not required to...
Foundation Medicine and its Collaborators Present New Findings Support...
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Foundation Medicine, Inc. (NASDAQ:FMI) today announced the presentation of new findings at the American Association for Cancer Research (AACR) Annual Meeting. The data supports the use of both tissue- and blood-based comprehensive genomic profiling (CGP) to advance personalized cancer care and inform the use of targeted and immunotherapy treatment approaches. Presentations span several of Foundation Medicine’s suite of molecular information products including its recently FDA approved assay, ...
Foundation Medicine Announces Commercial Availability of FoundationOne...
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Foundation Medicine, Inc. (NASDAQ:FMI) today announced that FoundationOne CDx™, the first U.S. Food and Drug Administration (FDA) approved comprehensive genomic profiling (CGP) assay for all solid tumors incorporating multiple companion diagnostics, is now available in the United States. FoundationOne CDx is a first-of-its-kind test for individuals with advanced cancer that is offered as a nationally covered benefit across all solid tumors for Medicare and Medicare Advantage beneficiaries who ...
Foundation Medicine Announces Final National Coverage Determination (N...
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Foundation Medicine, Inc. (NASDAQ:FMI) today announced that the Centers for Medicare & Medicaid Services (CMS) issued a final National Coverage Determination (NCD) for patients who receive next generation sequencing (NGS) testing with an assay that meets the coverage criteria. Medicare and Medicare Advantage patients who receive testing with FoundationOne CDx™, the first FDA-approved comprehensive genomic profiling (CGP) assay for all solid tumors incorporating a broad set of companion diagnostics, ...
Foundation Medicine Advances Patient Access to Precision Medicine; Pur...
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Foundation Medicine, Inc. (NASDAQ:FMI) today announced that Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519), one of Japan's leading research-based pharmaceutical companies and a member of the Roche Group, will broaden patient access to Foundation Medicine’s comprehensive genomic profiling (CGP) services for individuals with advanced cancer. Specifically, Chugai has filed for regulatory approval from the Ministry of Health, Labour and Welfare (MHLW) in Japan for FoundationOne CDx™, which, if app...
Foundation Medicine and Guardant Health Agree to Resolve False Adverti...
CAMBRIDGE, Mass. & REDWOOD CITY, Calif.--(BUSINESS WIRE)-- Foundation Medicine, Inc. (NASDAQ:FMI) and Guardant Health, Inc. announced an agreement to settle false advertising challenges that the companies had filed against each other under the Lanham Act related to advertising for their respective liquid genomic profiling assays. Under the terms of the settlement, the lawsuit and counterclaims will be dismissed with prejudice. The companies also agreed to create a rapid-resolution process in the event of further advertising-rel...
Foundation Medicine to Present at Cowen and Company’s 38th Annual He...
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Foundation Medicine, Inc. (NASDAQ:FMI) today announced that members of the company's management team will present at Cowen & Company’s 38th Annual Healthcare Conference on Wednesday, March 14, 2018, at 10:40 a.m. ET in Boston. A live, listen-only webcast of the presentation may be accessed by visiting the investors section of the company’s website at investors.foundationmedicine.com. A replay of the webcast will be available shortly after the conclusion of the presentation and will b...
Foundation Medicine Announces 2017 Fourth Quarter and Year-End Results...
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Foundation Medicine (NASDAQ:FMI) today reported financial and operational results for the fourth quarter and year ended December 31, 2017. Highlights for the quarter and year included: Fourth quarter revenue of $48.9 million, 70% year-over-year growth; Full year 2017 revenue of $152.9 million, 31% year-over-year growth; 20,044 clinical tests reported in the fourth quarter, 57% year-over-year growth; 67,375 clinical tests reporte...
Foundation Medicine Announces Timing for Fourth Quarter and Year-End 2...
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Foundation Medicine, Inc. (NASDAQ:FMI) today announced that financial results for the company's fourth quarter and year ended December 31, 2017 will be released on Wednesday, March 7, 2018. The management team will host a conference call on Wednesday, March 7, 2018, at 4:30 p.m. ET to discuss the company's financial results and recent developments. The call can be accessed by dialing 1-877-270-2148 (domestic) or 1-412-902-6510 (international) five minutes prior to the start of the call. A passcode ...
Foundation Medicine and European Organisation for Research and Treatme...
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Foundation Medicine, Inc. (NASDAQ:FMI) and the European Organisation for Research and Treatment of Cancer (EORTC) announced today a collaboration in which Foundation Medicine’s comprehensive genomic profiling (CGP) tests will be used to inform patient eligibility for oncology clinical trials through the EORTC’s Screening Patients for Efficient Clinical Trial Access (SPECTA) program. SPECTA is a pan-European network built by the EORTC with key institutions collaborating to provide efficient ac...
Foundation Medicine and Pfizer Announce Broad Partnership to Develop C...
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Foundation Medicine, Inc. (NASDAQ:FMI) today announced that the company has entered into a broad partnership with Pfizer Inc. (NYSE: PFE). The partnership focuses on development, regulatory support and commercialization of companion diagnostics (CDx) that will be included in updates to FoundationOne CDx™. FoundationOne CDx is Foundation Medicine’s FDA-approved comprehensive genomic profiling (CGP) assay for all solid tumors that incorporates multiple companion diagnostics. Pfizer will also be...
Foundation Medicine Reports Preliminary 2017 Results
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Foundation Medicine (NASDAQ:FMI) today announced preliminary unaudited total revenue of approximately $48.9 million for the fourth quarter of 2017 and approximately $152.9 million for the full year ended December 31, 2017, representing a 70% and 31% increase from the $28.8 million and $116.9 million recorded in the fourth quarter and full year ended December 31, 2016, respectively. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/2018010800571...
Foundation Medicine to Present at the 36th Annual J.P. Morgan Healthca...
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Foundation Medicine today announced that Troy Cox, chief executive officer, is scheduled to present at the 36th Annual J.P. Morgan Healthcare Conference on Monday, January 8, 2018 at 3:30 p.m. PST in San Francisco. Additionally, Troy Cox will participate in a panel discussion focused on the Food & Drug Administration and Centers for Medicare and Medicaid Services Parallel Review process on Monday, January 8, 2018 at 5:15 p.m. PST. Live, listen-only webcasts of these presentations can...
Foundation Medicine and Collaborators to Present New Data at the Ameri...
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Foundation Medicine, Inc. (NASDAQ:FMI) today announced that new data generated with FoundationOne®Heme, its comprehensive genomic profiling (CGP) assay for hematologic malignancies and sarcomas, will be presented at the American Society of Hematology (ASH) Annual Meeting. Data from a broad range of blood cancers, including acute myeloid leukemia (AML), myeloproliferative neoplasms (MPN), and non-Hodgkin lymphoma (NHL), including primary central nervous system lymphoma (PCL), demonstrate the v...
FDA Approves Foundation Medicine’s FoundationOne CDx™, the First a...
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Foundation Medicine, Inc. (NASDAQ:FMI) today announced that the U.S. Food and Drug Administration (FDA) approved FoundationOne CDx™, the company’s comprehensive companion diagnostic test for solid tumors. 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. The first and only FDA-approved test of its kind for all solid tumors, FoundationOne CDx is a diagnostic te...
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