Foundation Medicine Reports Preliminary 2017 Results
Reports Total Revenue of Approximately
Increases Biopharma Revenue Approximately 27% Year-Over-Year with New and Expanded Collaborations
Achieves Significant Milestone with FDA Approval and Preliminary National Coverage Determination (NCD) for FoundationOne CDx™
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"2017 was a year of significant milestones for
Revenue from biopharmaceutical companies is expected to be approximately
Revenue from clinical testing is expected to be approximately
Based on the new revenue reporting the company initiated during 2017, Molecular Information Services revenue is expected to be approximately
Cash and cash equivalents at December 31, 2017 was approximately $71.4 million, including
2017 Enterprise Highlights:
- Received approval from the
U.S. Food & Drug Administration (FDA) under the parallel review process for FoundationOne CDx, the first broad genomic profiling test incorporating multiple companion diagnostics. Simultaneously, theCenters for Medicare and Medicaid Services (CMS) issued a preliminary NCD for FoundationOne CDx, which is expected to improve access to molecular information for personalized healthcare. The NCD is expected to be finalized during the first quarter of 2018. - Grew the biopharma business with new and expanded collaborations for molecular information solutions including companion diagnostics, molecular profiling, data insights, and biomarker discovery.
- Presented validation data for a novel assay measuring tumor mutational burden in blood (bTMB) providing evidence that response to immunotherapy can be predicted using a blood sample. Based on these findings, Foundation Medicine's bTMB assay is being integrated as part of Roche/
Genentech's prospective, randomized Phase III Blood First Assay Screening Trial (BFAST) as a companion diagnostic assay investigating the use of bTMB as a non-invasive biomarker of response to first-line atezolizumab in advanced NSCLC patients. - Received approval from the
State of New York Department of Health for FoundationACT ®, the company's liquid biopsy assay. - Announced a collaboration with the American Society of Clinical Oncology (ASCO) to identify patients for its Targeted Agent and Profiling Utilization Registry (TAPUR) study.
- Announced a collaboration with the National Cancer Institute (NCI) and
ECOG-ACRIN Cancer Research Group to identify patients for the NCI-Match (Molecular Analysis for Therapy Choice) study. - Increased FoundationCORE™, the company's molecular information database, to nearly 180,000 clinical cases.
- Expanded the company's global footprint and patient access to personalized healthcare by commencing operations at the company's laboratory in Penzberg,
Germany . The Penzberg location is supporting continued growth and expansion inEurope through the company's commercial collaboration withRoche . - Published 95 peer-reviewed manuscripts in top medical and scientific journals and presented 141 podium talks and posters at scientific and medical meetings.
Complete 2017 fourth quarter and full year financial results will be announced during the company's fourth quarter and fiscal year 2017 financial results conference call. The company also anticipates providing 2018 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.
Mr. Cox is scheduled to present at the 36th Annual J.P. Morgan Healthcare Conference on Monday, January 8, 2017, at 3:30 p.m. PST, in San Francisco. Additionally,
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