Foundation Medicine Adds New Immunotherapy Features to Its Market-Leading Products
August 22 2016 - 7:30AM
Business Wire
-- First Fully-Integrated and Validated
Assessments of Tumor Mutational Burden (TMB) and Microsatellite
Instability (MSI) Provide Oncologists with a Single Testing
Solution to Guide Personalized Immunotherapy-based Treatment Plans
--
Foundation Medicine, Inc. (NASDAQ:FMI) today announced the
addition of new clinical markers to its FoundationOne® and
FoundationOne® Heme products, which are designed to enhance
oncologists’ insight into potential response to immunotherapies.
This ability to determine TMB and MSI from its assays is additional
to the existing comprehensive profiling of genes provided by
FoundationOne and FoundationOne Heme. Taken together, the molecular
information provided by Foundation Medicine provides unique
insights to physicians and enhances their ability to predict
response to immunotherapies, identify targeted therapeutic options,
and improve access to clinical trials all from a single assay.
“Cancer immunotherapies are at the forefront of cancer
treatment, and new, quantitative approaches are needed to predict
clinical responses to this important, but also expensive, class of
therapies,” said Vincent Miller, M.D., chief medical officer of
Foundation Medicine. “Prior to our ability to measure TMB and MSI
with FoundationOne, these biomarkers could only be detected
separately, either through tests such as immunohistochemistry,
polymerase chain reaction (PCR) or whole exome sequencing.
Importantly, high-quality, predictive TMB scoring can only be
accurately performed with sophisticated algorithms developed to
work with broad, hybrid capture-based platforms that can analyze
all relevant alterations simultaneously. Integrating this
capability to measure TMB and MSI with one tissue sample, and
reported in one test, represents an important advance in clinical
care.”
A growing body of evidence, most recently presented at the
American Society of Clinical Oncology (ASCO) annual meeting this
year, validates the ability of a new independent marker, TMB, to
predict the likelihood of response to cancer immunotherapies. TMB
is reported as the total number of DNA mutations per megabase in a
tumor sequence. This phenomenon has been validated across a wide
range of tumor types, including advanced bladder cancer, lung
cancer, breast cancer, colorectal cancer, advanced head and neck
cancer and melanoma. Some tumors develop high TMB as a result of
defective mismatch repair of DNA, a condition in which the length
of certain DNA areas becomes more widely varied than normal. This
condition, which is referred to as MSI-high and MSI-high tumors,
almost always has a high TMB.
“The ability to accurately measure multiple biomarkers
simultaneously, including TMB and MSI, is an important advance for
the field of cancer immunotherapy, and one that is unique to
Foundation Medicine,” said Thomas George, M.D., GI oncology program
director, University of Florida. “Foundation Medicine’s combination
of advanced sequencing platforms and highly-specific algorithms
gives me access to all relevant genomic biomarkers for my patients
at once, helping to save both time and tissue.”
“We were encouraged by the findings presented at ASCO, including
the possibility of identifying patients more likely to benefit from
checkpoint inhibitor immunotherapy,” said Dr. Miller. “Our goal is
to empower doctors and patients with a full range of relevant,
actionable genomic information, and we’re excited to offer our
distinctive solution to estimate TMB and MSI simultaneously and
with exceptional accuracy, supported by sophisticated algorithms
and rooted in contextual insights from our knowledgebase
FoundationCORE™. This is something no other next-generation
sequencing platform offers.”
Independent of the FoundationOne and FoundationOne Heme assays,
Foundation Medicine also offers testing for PD-1 and PD-L1 protein
expression, providing, in combination with the FoundationOne
assays, a full suite of cancer immunotherapy assays for
oncologists.
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® and FoundationOne® are registered
trademarks, and FoundationCore™ is a trademark, of Foundation
Medicine, Inc.
Cautionary Note Regarding Forward-Looking Statements for
Foundation Medicine
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 and FoundationOne Heme to identify and
predict the likelihood of response to immunotherapies, and the
ability of FoundationOne and FoundationOne Heme to inform
therapeutic choices in cancer, including leading to
physician-directed therapy changes and to improve patient outcomes.
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
company’s TMB and MSI analysis do not perform as expected or the
results thereof are not widely accepted; subsequent research
renders TMB and/or MSI status less useful or not useful in clinical
practice; physicians may not be able to obtain access to relevant
targeted therapies, immunotherapies or clinical trials matched to
molecular findings identified by FoundationOne or FoundationOne
Heme as readily as expected; 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, 2015,
which is on file with the Securities and Exchange Commission,
as well as other risks detailed in 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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version on businesswire.com: http://www.businesswire.com/news/home/20160822005083/en/
Media Contact:Dan Budwick, Pure Communications,
Inc.973-271-6085dan@purecommunicationsinc.comorInvestor
Contact:Kimberly Brown, Foundation Medicine,
Inc.617-418-2215ir@foundationmedicine.com
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