-- 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 --
CAMBRIDGE, Mass.--(BUSINESS WIRE)--
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) 18thWorld 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,
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, Inc.
About the WCLC
The 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
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 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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20171016005038/en/
Foundation Medicine, Inc.
Kimberly Brown, 617-418-2215
Source: Foundation Medicine, Inc.
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