-- 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 --
CAMBRIDGE, Mass.--(BUSINESS WIRE)--
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
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 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
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 and FoundationOne CDx™ is a trademark of Foundation Medicine,
Cautionary Note Regarding Forward-Looking Statements for Foundation
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 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20180330005010/en/
Kimberly Brown, 617-418-2215
Source: Foundation Medicine, Inc.
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