Foundation Medicine Announces Commercial Availability of FoundationOne CDx™, the First FDA-Approved Comprehensive Genomic Profiling Assay for All Solid Tumors Incorporating Multiple Companion Diagnostics
-- FoundationOne CDx is the First Next Generation Sequencing Test for All Solid Tumors to Complete the
"Now that FoundationOne CDx is widely available in the
Expanded access to clinically and analytically validated genomic profiling may establish a path toward improved patient outcomes. Personalized, biomarker-based therapy has been shown to be associated with clinical benefit across tumor types and biomarkers,1 making therapy selection ever more complex. FoundationOne CDx offers treating physicians a single,
FoundationOne CDx, an
FoundationOne CDx is available to order online at www.foundationmedicine.com/genomic-testing/order, or visit https://home.foundationmedicine.com/signup to sign up for an account.
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. FoundationOne CDx is intended as a companion diagnostic to identify patients who may benefit from treatment with certain targeted therapies in accordance with their 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. For a full list of targeted therapies for which FoundationOne CDx is indicated as a companion diagnostic, please visit http://www.foundationmedicine.com/genomic-testing/foundation-one-cdx.
About
Cautionary Note Regarding Forward-Looking Statements for
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 ability of FoundationOne CDx to create treatment efficiencies and expand patient access to comprehensive genomic profiling and biomarker-driven medicines; the ability of FoundationOne CDx to improve treatment outcomes; the benefits of FoundationOne CDx to oncologists and patients in the treatment of cancer; and the timing, scope and potential benefits to the oncology community of the commercial 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
1 Jardim DL, Schwaederle M, Wei C, et al. Impact of a Biomarker-Based Strategy on Oncology Drug Development: A Meta-Analysis of Clinical Trials Leading to FDA Approval. J Natl Cancer Inst. 2015;15;107(11). doi: 10.1093/jnci/djv253. PMID: 26378224.
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