Foundation Medicine to Present Validation for FoundationOne CDx™, a Comprehensive Genomic Profiling Assay for Advancing Pre...
October 16 2017 - 7:00AM
Business Wire
-- Data demonstrated high concordance
between FoundationOne CDx and multiple FDA-approved companion
diagnostics across five solid tumor cancer types, providing the
capability to predict response for up to 15 targeted therapies
--
Foundation Medicine, Inc. (NASDAQ:FMI) today announced that the
company will present validation data for FoundationOne CDx, its
comprehensive genomic profiling assay, at the International
Association for the Study of Lung Cancer (IASLC) 18th World
Conference on Lung Cancer (WCLC). Data demonstrated high
concordance with multiple companion diagnostics and other single
marker assays currently used to match targeted therapies to people
with certain types of non-small cell lung cancer (NSCLC), melanoma,
colorectal cancer, ovarian cancer or breast cancer. The
availability of a comprehensive genomic profiling assay that is
concordant with multiple companion diagnostics has the potential to
advance personalized healthcare for all constituents by providing
biopharma companies a platform for accelerated drug development and
by improving efficient access to targeted therapies for
patients.
FoundationOne CDx is a comprehensive genomic profiling (CGP)
assay that incorporates multiple companion diagnostics in a single
platform with molecular profiling of the 320+ genes known to drive
cancer growth. These validation data are also included in the
Premarket Approval Application (PMA) for FoundationOne CDx which is
currently under review by the U.S. Food and Drug Administration
(FDA) and also by the Centers for Medicare & Medicaid Services
(CMS) as part of their Parallel Review program for breakthrough
devices. FoundationOne CDx is not commercially available at this
time.
“The landscape of targeted cancer treatments and associated
companion diagnostics has grown tremendously in recent years.
However, the ability to match tumor-specific molecular information
to appropriate treatments is limited by single gene and hot spot
panel tests that can exhaust valuable time and tissue,” said
Vincent Miller, M.D., chief medical officer at Foundation Medicine.
“We are excited by our data that demonstrate high concordance
between FoundationOne CDx and seven FDA-approved companion
diagnostics. The biomarkers confirmed through clinical concordance
studies collectively are indicated for use for up to 15 targeted
therapies across multiple tumor types, including lung cancer. A
single, comprehensive, pan-cancer profiling assay that is
concordant with multiple companion diagnostic assays, has the
potential to provide significant benefits to patients and
physicians, and to accelerate the development of new personalized
treatments.”
Results showed that FoundationOne CDx detected alterations in
the EGFR, ALK, BRAF, ERBB2, KRAS and BRCA1/2 genes and demonstrated
concordance with FDA-approved companion diagnostics currently used
to match targeted therapies to patients with certain types of
non-small cell lung cancer (NSCLC), melanoma, colorectal cancer,
ovarian cancer or breast cancer. In each of the separate studies,
concordance was measured as positive percent agreement (PPA) with
other FDA-approved tests.
The presentations will take place at the following times:
P2.02-052 -- A clinically-validated universal companion
diagnostic platform for cancer patient care, Oct 17, 9:30am-4:00pm
JST, Exhibit Hall (Poster Presentation)
P3.02-061 -- An ALK follow-on companion diagnostic using
CGP for clinical care of patients with NSCLC, Oct 18, 9:30am-4:00pm
JST, Exhibit Hall (Poster Presentation)
P3.02-062 -- An EGFR follow-on companion diagnostic for
clinical care of patients with NSCLC, Oct 18, 9:30am-4:00pm JST,
Exhibit Hall (Poster Presentation)
Foundation Medicine and its collaborators will make a total of
nine presentations at the meeting, including two oral
presentations, three mini-oral presentations and four posters which
support the ability of CGP to guide more informed and personalized
care in lung cancer. In addition to the FoundationOne CDx
concordance data, new data will also include characterization of
genomic alterations which may be associated with response or
resistance to certain targeted treatments or immunotherapy, such as
MET amplifications or alterations in PTCH1 or STK11 genes. Together
these findings provide new insights into the genomic drivers of
lung cancer to guide more precise treatment and support the use of
CGP in clinical care.
The IASLC 18th WCLC is being held October 15-18 in Yokohama,
Japan.
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.
About the WCLCThe World Conference on Lung Cancer is the
world’s largest meeting dedicated to lung cancer and other thoracic
malignancies, attracting over 6,000 researchers, physicians and
specialists from more than 100 countries. The goal is to
disseminate the latest scientific achievements; increase awareness,
collaboration and understanding of lung cancer; and to help
participants implement the latest developments across the globe.
For more information, visit http://wclc2017.iaslc.org/.
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 and clinical trials; the ability of
CGP to improve patient outcomes; and the scope and timing of any
approval of FoundationOne CDx as a medical device by the FDA and
any coverage decision by CMS. 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 results presented are
found to lack scientific, medical or clinical utility or that
subsequent research renders the results presented less useful or
not useful in clinical practice; the FDA does not approve
FoundationOne CDx as a medical device or that CMS does not decide
to offer FoundationOne CDx as a covered benefit under Medicare; 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.
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Foundation Medicine, Inc.Media Contact:Lee-Ann Murphy,
617-245-3077pr@foundationmedicine.comorInvestor
Contact:Kimberly Brown,
617-418-2215ir@foundationmedicine.com
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