Foundation Medicine, Inc. (FMI)

WICHITA, Kan. , Jan. 13, 2025 /PRNewswire/ -- Today, Spirit AeroSystems Holdings, Inc. (NYSE: SPR) ("Spirit," "Spirit AeroSystems" or the "Company") announced the sale of Fiber Materials Inc ("FMI") business based in Biddeford, Maine, and Woonsocket, Rhode Island, to Tex Tech Industries, Inc. ("Tex-Tech") for $165 million in cash.

WICHITA, Kan. , Nov. 18, 2024 /PRNewswire/ -- Today, Spirit AeroSystems Holdings, Inc. (NYSE: SPR) ("Spirit," "Spirit AeroSystems" or the "Company") announces a purchase agreement to sell Fiber Materials, Inc ("FMI") business based in Biddeford, Maine, and Woonsocket, Rhode Island, to Tex-Tech Industries, Inc. ("Tex-Tech") for $165,000,000 in cash, subject to customary adjustment.

BOSTON and PRINCETON, N.J., May 29, 2024 (GLOBE NEWSWIRE) -- Foundation Medicine, Inc. and PMV Pharmaceuticals, Inc. (NASDAQ: PMVP; “PMV Pharma”) today announced a partnership to develop Foundation Medicine's tissue-based comprehensive genomic profiling test, FoundationOne®CDx, as a companion diagnostic for PMV Pharma's rezatapopt, a first-in-class, investigational therapy for patients with locally advanced or metastatic solid tumors that have a TP53 Y220C mutation.

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 access the live call from either number. A replay of the conference call will be available until May 16, 2018 and can be accessed by dialing 1-412-317-0088 and providing the passcode 10119532. The live, listen-only webcast of the conference call 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 call and will be archived on the company's website for two weeks following the call. About Foundation MedicineFoundation 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). Foundation Medicine® is a registered trademark of Foundation Medicine, Inc.

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 is not required to access the live call from either number. A replay of the conference call will be available until March 21, 2018 and can be accessed by dialing 1-412-317-0088 and providing the passcode 10117039. The live, listen-only webcast of the conference call 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 call and will be archived on the company's website for two weeks following the call. About Foundation MedicineFoundation 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). Foundation Medicine® is a registered trademark of Foundation Medicine, Inc.

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 test that acts as: a comprehensive companion diagnostic to identify patients who may benefit from treatment with specific FDA-approved targeted therapies; a comprehensive genomic profiling (CGP) test that includes genomic biomarkers to help inform the use of other targeted oncology therapies, including immunotherapies; a tool for physicians that identifies patient opportunities for clinical trial participation; and, an FDA-approved platform for companion diagnostic development for biopharma companies developing precision therapeutics. FoundationOne CDx assesses all classes of genomic alterations in 324 genes known to drive cancer growth, providing potentially actionable information to help guide treatment decisions. It is also indicated as a companion diagnostic for patients with certain types of non-small cell lung cancer (NSCLC), melanoma, colorectal cancer, ovarian cancer or breast cancer to identify those patients who may benefit from treatment with one of 17 on-label targeted therapies, including 12 therapies currently approved as first-line therapy for their respective indications. FoundationOne CDx also reports genomic biomarkers, such as microsatellite instability (MSI) and tumor mutational burden (TMB), that can help inform the use of immunotherapies; genomic alterations in other genes relevant to patient management; and, relevant clinical trial information. Based on previous CGP testing conducted by Foundation Medicine, it is estimated that approximately 1 in 3 patients across five common advanced cancers are expected to match with an FDA approved therapy.1 The number of matched on-label therapies indicated on FoundationOne CDx is expected to increase over time as Foundation Medicine and its biopharma partners pursue FDA approval for additional companion diagnostics on the platform. Today, approximately 50% of new cancer drugs in development are projected to have a companion biomarker.2 Concurrent with FDA approval, the Centers for Medicare and Medicaid Services (CMS) issued a preliminary National Coverage Determination (NCD) for FoundationOne CDx. The draft NCD would provide coverage for FDA-approved companion diagnostic claims, as well as a pathway for additional coverage with evidence development in other solid tumor types. The final policy is expected to issue during the first quarter of 2018 following public comment of the preliminary NCD and an administrative period. “Today we know that many people with cancer do not receive biomarker testing, let alone the comprehensive genomic testing they need to be efficiently matched to the best therapeutic option,” said Andrea Ferris, President and CEO of LUNGevity Foundation. “This FDA approval means that, in one test, patients can access therapies where companion diagnostics have been established for their cancer while getting a broad tumor profile that can identify the therapies and clinical trials they could most benefit from. Along with the preliminary national coverage determination, this has the potential to democratize next-generation sequencing, lowering the barriers for patients treated in the community to access these biomarker-driven treatments.” “Comprehensive genomic profiling is the gateway to precision medicine. This decision from the FDA and CMS, which may lead to coverage for Medicare patients, represents an important step forward in improving patient and clinician access to precision medicine – both in setting a new quality standard for this type of testing and offering potentially improved healthcare coverage,” said Ankur R. Parikh, DO, Medical Director of Precision Medicine, Cancer Treatment Centers of America. “Access to important genomic information is a critical step in being able to offer innovative and targeted treatment options.” FoundationOne CDx results are delivered in an integrated report that identifies alterations matched to FDA approved therapies, identifies additional alterations in genes known to drive cancer growth, furnishes information about genomic biomarkers, including MSI and TMB, provides relevant clinical trial information, and includes interpretive content developed in accordance with professional guidelines in oncology for patients with any solid tumor. “Today’s historic parallel review decision from the FDA and CMS represents a major advancement in personalized cancer care,” said Troy Cox, chief executive officer at Foundation Medicine. “Physicians will have an FDA-approved test for all solid tumors in their toolkit that can inform targeted and immunotherapy selection, as well as identify patient opportunities for clinical trial participation. Beyond its implications for patient care, we expect that FoundationOne CDx will provide biopharma companies with an FDA-approved platform that can help accelerate drug development and enable personalized oncology care. On behalf of the Foundation Medicine team, I’d like to thank FDA and CMS for their leadership and collaboration as we continue to work through the parallel review process with a shared mission of transforming cancer care.” FoundationOne CDx is the first solid tumor comprehensive genomic profiling test reviewed by the FDA and CMS in their Parallel Review program. FDA approval was based on analytic validation and concordance studies with FDA-approved assays. FoundationOne CDx is expected to be commercially available following finalization of the NCD from CMS. Conference Call and Webcast DetailsFoundation Medicine will conduct a conference call to discuss FDA approval and the draft national coverage determination from CMS for FoundationOne CDx on Friday, December 1 at 8:30 a.m. ET. To access the conference call via phone, dial 1-877-270-2148 from the United States and Canada, or dial 1-412-902-6510 internationally, and for either number reference Foundation Medicine. Dial in approximately ten minutes prior to the start of the call. The live, listen-only webcast of the conference call 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 call and will be archived on the company's website for two weeks following the call. About FoundationOne CDx™FoundationOne CDx™ is a next generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) 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 paraffin embedded (FFPE) tumor tissue specimens. The test is intended as a companion diagnostic to identify patients who may benefit from treatment with the targeted therapies listed below in accordance with the approved therapeutic product labeling. Additionally, FoundationOne CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. The FoundationOne CDx assay is a single-site assay performed at Foundation Medicine, Inc. EGFR exon 19 deletions and EGFR exon 21 L858R alterations, which may indicate efficacy of erlotinib, afatinib or gefitinib in patients with NSCLC. EGFR exon 20 T790M alterations which may indicate efficacy of osimertinib in NSCLC patients ALK rearrangements which may indicate efficacy of crizotinib, alectinib or certinib in NSCLC patients BRAF V600E which may indicate efficacy of dabrafenib in combination with trametinib in NSCLC patients BRAF V600E which may indicate efficacy of vemurafenib or dabrafenib in melanoma patients BRAF V600E and V600K which may indicate efficacy of trametinib or cobimetinib in combination with vemurafenib in melanoma patients ERBB2 (HER2) amplification which may indicate efficacy of trastuzumab, pertuzumab orado-trastuzumab-emtansine in patients with breast cancer KRAS wild-type (absence of mutations in codons 12 and 13) which may indicate efficacy of cetuximab in patients with colorectal cancer KRAS wild-type (absence of mutations in exons 2, 3 and 4) and NRAS wild-type (absence of mutations in exons 2, 3 and 4) which may indicate efficacy of panitumumab in patients with colorectal cancer BRCA1/2 alterations which may indicate efficacy of rucaparib in patients with ovarian cancer For more information about FoundationOne CDx, visit http://www.FoundationMedicine.com. About Foundation MedicineFoundation 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). Foundation Medicine® is a registered trademark of Foundation Medicine, Inc. Cautionary Note Regarding Forward-Looking Statements for Foundation MedicineThis 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 the ability of FoundationOne CDx to enhance patient access to targeted therapies, immunotherapies, and clinical trials, including the number of patients who will be matched to an on-label therapy; the ability of a comprehensive genomic profiling assay, including FoundationOne CDx, to improve patient outcomes; the benefits of our products to physicians, biopharmaceutical companies, payers, and patients in the treatment of cancer and personalized cancer care, including whether the number of on-label therapies indicated on FoundationOne CDx will increase over time; the benefits provided by an FDA-approved and CMS-covered FoundationOne CDx assay; any anticipated adoption of FoundationOne CDx for patient treatment; potential healthcare coverage of FoundationOne CDx by CMS for patients, including Medicare and Medicare Advantage patients; the scope and timing of any coverage decision by CMS, including the timing of issuance of any final NCD; and the timing of any launch of FoundationOne CDx. 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 risks that CMS does not issue a final NCD or issues a final NCD with a revised scope of coverage; CMS is delayed in the completion of the Parallel Review process; Foundation Medicine is not able to provide FoundationOne CDx for commercial use in the manner or on the timeline currently anticipated by management; Foundation Medicine is unable to sustain or grow relationships with hospitals, physicians, and biopharmaceutical partners; 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, 2016, which is on file with the Securities and Exchange Commission, as well as other risks detailed in Foundation Medicine's subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Foundation Medicine undertakes no duty to update this information unless required by law. 1 Estimates are projections based on a genomic database of patients with non-small cell lung cancer (NSCLC), melanoma, colorectal cancer, ovarian cancer or breast cancer who have received CGP testing from Foundation Medicine as of August 2017; these are the five cancer types for which FoundationOne CDx is approved to detect alterations that have associated on-label FDA approved therapies.2 Developments in Cancer Treatments, Market Dynamics, Patient Access and Value - Global Oncology Trend Report 2015. IMS Institute for Healthcare Informatics. Available at: http://keionline.org/sites/default/files/IIHI_Oncology_Trend_Report_2015.pdf.

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Foundation Medicine, Inc. (NASDAQ:FMI) today announced that financial results for the company's third quarter ended September 30, 2017 will be released on Wednesday, November 1, 2017. The management team will host a conference call on Wednesday, November 1, 2017, 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 is not required to access the live call from either number. A replay of the conference call will be available until November 15, 2017 and can be accessed by dialing 1-412-317-0088 and providing the passcode 10113366. The live, listen-only webcast of the conference call 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 call and will be archived on the company's website for two weeks following the call. About Foundation MedicineFoundation 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). Foundation Medicine® is a registered trademark of Foundation Medicine, Inc.

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Foundation Medicine, Inc. (NASDAQ:FMI) today announced that financial results for the company's second quarter ended June 30, 2017 will be released on Tuesday, August 1, 2017. The management team will host a conference call on Tuesday, August 1, 2017, 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 is not required to access the live call from either number. A replay of the conference call will be available until August 15, 2017 and can be accessed by dialing 1-412-317-0088 and providing the passcode 10110537. The live, listen-only webcast of the conference call 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 call and will be archived on the company's website for two weeks following the call. About Foundation MedicineFoundation 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). Foundation Medicine® is a registered trademark of Foundation Medicine, Inc.

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Foundation Medicine, Inc. (NASDAQ:FMI) today announced that financial results for the company's first quarter ended March 31, 2017 will be released on Tuesday, May 9, 2017. The management team will host a conference call on Tuesday, May 9, 2017, at 4:30 p.m. ET to discuss the company's financial results and recent developments. The call can be accessed by dialing 1-855-420-0652 (domestic) or 1-484-365-2939 (international) five minutes prior to the start of the call and providing the passcode 10842512. The live, listen-only webcast of the conference call 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 call and will be archived on the company's website for two weeks following the call. About Foundation MedicineFoundation 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). Foundation Medicine® is a registered trademark of Foundation Medicine, Inc.

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, 2016 will be released on Wednesday, February 22, 2017. The management team will host a conference call on Wednesday, February 22, 2017, at 4:30 p.m. ET to discuss the company's financial results and recent developments. The call can be accessed by dialing 1-855-420-0652 (domestic) or 1-484-365-2939 (international) five minutes prior to the start of the call and providing the passcode 61272791. The live, listen-only webcast of the conference call 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 call and will be archived on the company's website for two weeks following the call. About Foundation MedicineFoundation 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). Foundation Medicine® is a registered trademark of Foundation Medicine, Inc.

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Foundation Medicine (NASDAQ:FMI) today announced preliminary unaudited total revenue of approximately $28.8 million in the fourth quarter of 2016 and approximately $116.9 million for the full year ended December 31, 2016, an 11% and 25% increase from the $26.1 million and $93.2 million recorded in the fourth quarter and full year ended December 31, 2015, respectively. Revenue from biopharmaceutical companies is expected to be approximately $19.0 million in the fourth quarter of 2016 and approximately $78.8 million for the full year ended December 31, 2016, compared to $14.1 million and $44.0 million in the fourth quarter and full year ended December 31, 2015, respectively. Revenue from clinical testing is expected to be approximately $9.8 million in the fourth quarter of 2016 and approximately $38.1 million for the full year ended December 31, 2016, compared to $12.0 million and $49.2 million in the fourth quarter and full year ended December 31, 2015, respectively. The company reported 12,788 clinical tests to ordering physicians in the fourth quarter of 2016, compared to a total of 8,286 tests reported during the fourth quarter of 2015. A total of 43,686 clinical tests were reported to ordering physicians for the full year ended December 31, 2016, compared to 32,998 clinical tests reported in 2015. Cash, cash equivalents and marketable securities at December 31, 2016, was approximately $143 million. “Foundation Medicine evolved significantly in 2016, most notably through continued growth in clinical and biopharma product demand and utilization, product diversification through the launch of FoundationACT™ and the achievement of FoundationFocus™ CDxBRCA, our first FDA-approved companion diagnostic, and expanded reimbursement coverage with third party and government payers,” stated Michael J. Pellini, M.D., chief executive officer of Foundation Medicine. "As we look ahead to 2017, we believe we are well positioned for continued growth and further competitive differentiation, particularly as a result of our ongoing Parallel Review process with FDA and CMS for FoundationOne®.” 2016 Enterprise Highlights: Announced acceptance of FoundationOne for Parallel Review by FDA and CMS. The FDA also accepted Foundation Medicine's request for review as part of its Expedited Access Pathway (EAP) for breakthrough devices. If approved, FoundationOne could be the first FDA-approved comprehensive genomic profiling (CGP) assay to incorporate multiple companion diagnostics to support precision medicine in oncology and would be offered as a covered benefit to Medicare beneficiaries nationwide. Launched FoundationACT, the company’s ctDNA assay, to clinical customers. FoundationACT was developed with the same rigorous analytical validation standards as FoundationOne and FoundationOne Heme. Received FDA Approval of FoundationFocus CDxBRCA as a companion diagnostic for Rubraca™ (rucaparib) for the treatment of women with ovarian cancer. FoundationFocus is the first next generation sequencing companion diagnostic approved by the FDA and marks important progress towards the development of the company’s universal pan-cancer companion diagnostic assay. Expanded patient access to CGP through Palmetto, a Medicare administrative contractor in North Carolina, who broadened a Local Coverage Determination covering CGP for all stage IIIb and IV non-small cell lung cancer patients at diagnosis. Added new immunotherapy clinical markers, Tumor Mutational Burden (TMB) and Microsatellite Instability (MSI), to FoundationOne and FoundationOne Heme to help guide personalized, immunotherapy-based treatment plans. Grew biopharmaceutical revenue by approximately 79% in 2016 and added several new molecular information, SmartTrials™ and companion diagnostic collaborations. Increased FoundationCORE™, the company’s molecular information database, to more than 100,000 clinical cases. Expanded the company’s laboratory footprint to include sites at Research Triangle Park (RTP) in North Carolina and Penzberg, Germany. The RTP facility became operational in September, increasing operational flexibility and broadening commercial opportunities. Once operational, the Penzberg location will support continued growth and expansion in Europe through our commercial collaboration with Roche. Published 72 peer-reviewed manuscripts in top medical and scientific journals and presented 129 podium talks and posters at scientific and medical meetings. 2017 Outlook Dr. Pellini continued, “As we enter the year transitioning the chief executive officer post to Troy Cox, which will be completed in early February, we look forward to advancing our patient-centric mission and improving patient access to precision cancer care.” As part of Foundation Medicine’s commitment to being a partner for the patient journey, the company expects to advance a number of key business objectives in 2017. These include: advancing its universal, pan-cancer companion diagnostic assay through the FDA and CMS parallel review process to decision and launch in the second half of 2017; broadening Medicare and third-party payer coverage for its clinical CGP products; growing clinical volume across its product portfolio, including expanded global market presence; and expanding its biopharma business, including additional companion diagnostic collaborations and SmartTrials clinical trial access programs. Complete 2016 fourth quarter and full year financial results will be announced during the company's fourth quarter and fiscal year 2016 financial results conference call in February. The company also anticipates providing 2017 financial guidance at that time. This press release contains certain unaudited financial results for the company. These unaudited results could change as a result of further review by the company's management and its independent auditors. Dr. Pellini is scheduled to present at the 35th Annual J.P. Morgan Healthcare Conference on Tuesday, January 10, 2017, at 9:00 a.m. PST, in San Francisco. A live, listen-only webcast of the presentation and breakout session 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 breakout session and will be archived on the company's website for two weeks. 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). Foundation Medicine® and FoundationOne® are registered trademarks, and FoundationACT™, FoundationFocus™ and FoundationCORE™ are trademarks, of Foundation Medicine, Inc. Cautionary Note Regarding Forward-Looking Statements 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 the benefits of FoundationOne, FoundationOne Heme, FoundationACT and FoundationFocus CDxBRCA to physicians and patients in the treatment of cancer; the benefits provided by a FDA-approved version of FoundationOne; the scope and timing of any approval of FoundationOne as a medical device by the FDA and any coverage decision by CMS; strategies for achieving Medicare coverage decisions at the local or national level and new and expanded coverage from third-party payers; and the growth of clinical volumes within and outside the United States. 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 risks that the FDA does not approve FoundationOne as a medical device or that CMS does not decide to offer FoundationOne as a covered benefit under Medicare; the FDA or CMS is delayed in the completion of the Parallel Review process; the company’s new facilities in North Carolina and Germany do not facilitate the company’s ability to achieve it business objectives; the company’s distribution partner outside the United States is not able to achieve market penetration in new and existing markets as quickly or as extensively as projected; Foundation Medicine's relationships with third-party or government payers do not increase or expand; Foundation Medicine is unable to sustain or grow relationships with biopharmaceutical partners; the company's expectations and beliefs regarding the future conduct and growth of its business are inaccurate; Foundation Medicine is unable to achieve profitability, to compete successfully, to manage its growth, or to develop its molecular information platform; and the risks described under the caption "Risk Factors" in Foundation Medicine's Quarterly Report on Form 10-K for the year ended December 31, 2015, which is on file with the Securities and Exchange Commission, as well as other risks detailed in Foundation Medicine's subsequent filings with the Securities and Exchange Commission. With respect to Foundation Medicine's estimated cash, total revenue, clinical revenue and biopharma revenue, clinical tests and other financial and business results as of and for the year ended December 31, 2016, it should be noted that this information is unaudited and that the company has not finalized its financial and business results for the three and twelve months ended December 31, 2016. All information in this press release is as of the date of the release, and Foundation Medicine undertakes no duty to update this information unless required by law.

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Foundation Medicine, Inc. (NASDAQ:FMI) today announced that financial results for the company's third quarter ended September 30, 2016, will be released on Wednesday, November 2, 2016. The management team will host a conference call on Wednesday, November 2, 2016, at 4:30 p.m. ET to discuss the company's financial results and recent developments. The call can be accessed by dialing 1-855-420-0652 (domestic) or 1-484-365-2939 (international) five minutes prior to the start of the call and providing the passcode 96220274. The live, listen-only webcast of the conference call 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 call and will be archived on the company's website for two weeks following the call. 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). Foundation Medicine® is a registered trademark of Foundation Medicine, Inc.

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Foundation Medicine, Inc. (NASDAQ:FMI) today announced that financial results for the company's second quarter ended June 30, 2016, will be released on Tuesday, August 2, 2016. The management team will host a conference call on Tuesday, August 2, 2016, at 4:30 p.m. ET to discuss the company's financial results and recent developments. The call can be accessed by dialing 1-855-420-0652 (domestic) or 1-484-365-2939 (international) five minutes prior to the start of the call and providing the passcode 47501376. The live, listen-only webcast of the conference call 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 call and will be archived on the company's website for two weeks following the call. 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). Foundation Medicine® is a registered trademark of Foundation Medicine, Inc.

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Foundation Medicine, Inc. (NASDAQ:FMI) today announced that financial results for the company's first quarter ended March 31, 2016, will be released on Tuesday, May 3, 2016. The management team will host a conference call discussing the company's financial results and recent developments on Tuesday, May 3, 2016, at 4:30 p.m. ET. The call can be accessed by dialing 1-855-420-0652 (domestic) or 1-484-365-2939 (international) five minutes prior to the start of the call and providing the passcode 85678817. The live, listen-only webcast of the conference call 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 call and will be archived on the company's website for two weeks following the call. 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's clinical assays, FoundationOne® for solid tumors and FoundationOne® Heme for hematologic malignancies and sarcomas, provide a comprehensive genomic profile to identify the molecular alterations in a patient's cancer and match them with relevant targeted therapies 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). Foundation Medicine® and FoundationOne® are registered trademarks of Foundation Medicine, Inc.

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, 2015, will be released on Tuesday, February 23, 2016. The management team will host a conference call discussing the company's financial results and recent developments on Tuesday, February 23, 2016, at 4:30 p.m. ET. The call can be accessed by dialing 1-855-420-0652 (domestic) or 1-484-365-2939 (international) five minutes prior to the start of the call and providing the passcode 43868145. The live, listen-only webcast of the conference call 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 call and will be archived on the company's website for two weeks following the call. 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's clinical assays, FoundationOne® for solid tumors and FoundationOne® Heme for hematologic malignancies and sarcomas, provide a comprehensive genomic profile to identify the molecular alterations in a patient's cancer and match them with relevant targeted therapies 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). Foundation Medicine® and FoundationOne® are registered trademarks of Foundation Medicine, Inc.

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Foundation Medicine (NASDAQ:FMI) today announced preliminary unaudited total revenue of approximately $26.1 million in the fourth quarter of 2015 and $93.2 million for the full year ended December 31, 2015, a 39% and 53% increase from the $18.7 million and $61.1 million recorded in the fourth quarter and full year ended December 31, 2014, respectively. The company reported 8,286 clinical tests to ordering physicians in the fourth quarter of 2015, compared to a total of 7,233 tests reported during the fourth quarter of 2014. A total of 32,998 clinical tests were reported to ordering physicians for the full year ended December 31, 2015, compared to 24,271 clinical tests reported in 2014. Cash, cash equivalents and marketable securities at December 31, 2015, was approximately $232 million. “Foundation Medicine achieved significant strategic and operational advances across all aspects of our molecular information business in 2015 that position the Company for continued growth in 2016 and beyond,” stated Michael J. Pellini, M.D., chief executive officer of Foundation Medicine. “Specifically, we grew our commercial business and our molecular information platform to more than 68,000 cases, expanded our biopharmaceutical business both in terms of the number of partners and revenue, strengthened our leadership position through our collaboration with Roche, and secured our first national payer contract for metastatic non-small cell lung cancer with United Healthcare.” 2015 Enterprise Highlights: Completed a strategic transaction with Roche to further advance Foundation Medicine's market-leading position in molecular information and expand access to the company's products globally. Grew biopharmaceutical revenue by approximately 80% in 2015 and added new molecular information and companion diagnostic collaborations with Roche, H3 Biomedicine, Mirati Therapeutics, and several other partners. Improved patient access to comprehensive genomic profiling by signing a national agreement with United Healthcare for FoundationOne® in metastatic non-small cell lung cancer. Additionally, Palmetto GBA, a Medicare Administrative Contractor (MAC), announced a final local coverage determination for comprehensive genomic profiling in a subset of patients with non-small cell lung cancer. Expanded its molecular information platform to more than 68,000 cases. Advanced its circulating tumor DNA (ctDNA) assay program by initiating a large, multi-center clinical study to support the anticipated commercial launch of the assay in 2016. The ctDNA assay was launched to biopharmaceutical partners in 2015, as planned. Launched the Precision Medicine Exchange Consortium™ (PMEC) with leading academic medical centers and community oncology networks to advance the integration of molecular information into clinical oncology and accelerate the adoption of precision care. Launched decision support tools to help improve utilization of molecular information by oncologists and pathologists, including enhancements to FoundationICE™, such as PatientMatchTM and the introduction of GeneKitTM, a genomics solutions portal for pathologists. Published 56 peer-reviewed manuscripts in top medical and scientific journals and presented 101 podium talks and posters at scientific and medical meetings. 2016 Outlook The company expects revenue in 2016 will be in the range of $110 to $120 million and operating expenses will be in the range of $175 and $185 million. The company expects to deliver between 37,000 and 40,000 FoundationOne® and FoundationOne® Heme clinical tests in 2016. The company also expects to expand upon progress made in 2015 with Palmetto and commercial payers and drive additional coverage decisions. As part of its commitment to providing healthcare practitioners with a full suite of analytically validated genomic profiling assays to support precision medicine in oncology, the company plans to expand its offering of molecular information products with the commercial launch of its ctDNA assay in the first quarter 2016. The assay is being rigorously evaluated as part of an ongoing, multi-center study to identify patients who are most likely to benefit from liquid-based genomic profiling. The study will also provide the analytic validation mandated for clinical use of a commercial ctDNA assay. To further support the commercial launch of the assay, the laboratory will have expansion capability for a QSR-compliant version of the assay to support companion diagnostics for potential FDA approval. Complete quarterly and full year financial results will be announced during the company’s fourth quarter and fiscal year 2015 financial results conference call in February. This press release contains certain unaudited financial results for the company. These unaudited results could change as a result of further review by the company’s management and its independent auditors. Dr. Pellini is scheduled to present at the 34th Annual J.P. Morgan Healthcare Conference on Wednesday, January 13, 2016, at 9:30 a.m. PST, in San Francisco. A live, listen-only webcast of the presentation and breakout session 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 breakout session and will be archived on the company's website for two weeks. 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's clinical assays, FoundationOne® for solid tumors and FoundationOne® Heme for hematologic malignancies and sarcomas, provide a comprehensive genomic profile to identify the molecular alterations in a patient's cancer and match them with relevant targeted therapies 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). Foundation Medicine® and FoundationOne® are registered trademarks, and FoundationICETM, GeneKitTM, PatientMatchTM and Precision Medicine Exchange ConsortiumTM are 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. 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 risks that Foundation Medicine's test, revenue or operating expense projections may turn out to be inaccurate because of the preliminary nature of the forecasts; the launch of a ctDNA clinical assay is delayed or discontinued; the company's expectations and beliefs regarding the future conduct and growth of Foundation Medicine's business are inaccurate; Foundation Medicine is unable to achieve profitability, to compete successfully, to manage its growth, or to develop its molecular information platform; and the risks described under the caption “Risk Factors” in Foundation Medicine’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2015, which is on file with the Securities and Exchange Commission, as well as other risks detailed in Foundation Medicine’s subsequent filings with the Securities and Exchange Commission. With respect to Foundation Medicine’s estimated cash, revenue, clinical tests and other financial and business results as of and for the year ended December 31, 2015, it should be noted that this information is unaudited and that the company has not finalized its financial and business results for the three and twelve months ended December 31, 2015. All information in this press release is as of the date of the release, and Foundation Medicine undertakes no duty to update this information unless required by law.