Foundation Medicine Announces Commercial Availability of FoundationOne CDx™, the First FDA-Approved Comprehensive Genomic P...
March 30 2018 - 7:00AM
Business Wire
-- FoundationOne CDx is the First Next
Generation Sequencing Test for All Solid Tumors to Complete the
FDA/CMS Parallel Review Process and Launch with National Medicare
Coverage --
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 meet eligibility
requirements.
“Now that FoundationOne CDx is widely available in the U.S.,
oncologists can begin using this valuable test to help guide and
simplify personalized treatment decisions for their patients,”
Vincent Miller, M.D., chief medical officer at Foundation Medicine.
“By integrating FoundationOne CDx early into routine clinical care,
oncologists can create treatment efficiencies and expand access to
biomarker-driven medicines for patients, with the potential to
improve treatment outcomes.”
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, FDA-approved
comprehensive platform for all solid tumors to detect specific
genomic alterations that help guide efficient, personalized
treatment decisions, while reducing the time and tissue needed when
testing for biomarkers one at a time.
FoundationOne CDx, an FDA-approved CGP assay for all solid
tumors, assesses genomic alterations in 324 genes known to drive
cancer growth, providing potentially actionable information to help
guide treatment options. FoundationOne CDx is also FDA-approved as
a broad companion diagnostic for patients with certain types of
non-small cell lung cancer, 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, 12 of
which are 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 other targeted
oncology therapies, including immunotherapies and relevant clinical
trial information. In all of these ways, FoundationOne CDx is
available to biopharma companies as an FDA-approved platform for
clinical research and as a CGP platform for biopharma companies
seeking to develop companion diagnostics for their precision
therapeutics.
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 CDxFoundationOne 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 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 and FoundationOne
CDx™ is a 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 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 Foundation Medicine is not able to provide
FoundationOne CDx for commercial use in the manner or on the
timeline currently anticipated by management; and that the risks
described under the caption "Risk Factors" in Foundation Medicine's
Annual Report on Form 10-K for the year ended December 31, 2017,
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 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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Foundation MedicineMedia Contact:Lee-Ann Murphy,
617-245-3077pr@foundationmedicine.comorInvestor
Contact:Kimberly Brown,
617-418-2215ir@foundationmedicine.com
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