Study Aims to Demonstrate the Clinical Utility of, and Cost Savings
Achieved by, Integrating Comprehensive Genomic Profiling with
FoundationOne® into Clinical Pathways
CAMBRIDGE, Mass.--(BUSINESS WIRE)--
Medicine, Inc. (NASDAQ:FMI) today announced a three-way
collaboration with Horizon Healthcare Services, Inc., New Jersey's
oldest and largest health insurer, and Clinical Outcomes Tracking and
Analysis (COTA) to advance precision medicine, improve clinical outcomes
and deliver enhanced value to the healthcare system in the treatment of
patients with metastatic, non-small cell lung cancer (NSCLC). The
organizations initiated a prospective clinical study measuring changes
in survival benefit and total cost savings achieved among patients with
previously untreated metastatic NSCLC who undergo comprehensive genomic
profiling with FoundationOne®. Based on the outcomes, the study enables
Horizon to provide its members with coverage for FoundationOne as a
critical component of clinical care pathways in the evaluation of
patients with metastatic lung cancer.
As thought leaders and innovators in cancer care, the organizations
designed the study to support guidelines from the National Comprehensive
Cancer Network (NCCN) that specifically recommend broad molecular
profiling for patients with NSCLC. These guidelines enable the
identification of cancer-driving genomic alterations for which effective
targeted therapies may already be approved and available commercially or
to enable physicians to appropriately counsel patients regarding the
availability of clinical trials. This recommendation by NCCN and the
genesis of this trial supports the widespread understanding that cancer
is a disease of the genome and that tumors may harbor specific genomic
alterations likely to respond to "matched" therapies regardless of its
anatomic site of origin.
FoundationOne is a comprehensive genomic profile (CGP) that enables
physicians to make treatment decisions for patients with cancer by
identifying the molecular growth drivers of their cancers and by helping
oncologists match the identified drivers with relevant targeted
therapeutic options. Requiring only a small amount of tumor tissue,
FoundationOne interrogates the entire coding sequence of 315
cancer-related genes plus select introns from 28 genes that are known to
be altered in solid tumors.
"We believe this study design, which embraces the importance of data
sharing in molecular information, represents an innovative model of
collaboration that will catalyze the consistent integration of
comprehensive genomic profiling in clinical care for the treatment of
metastatic lung cancer," stated Vincent Miller, M.D., chief medical
officer for Foundation Medicine. "We fully expect the study to
demonstrate the clinical and health economic benefits of a comprehensive
approach versus the use of more limited testing panels and importantly,
that these results will support broad reimbursement in this patient
population with advanced disease," Miller added.
"Gene-by-gene testing, as is common practice today in metastatic NSCLC,
presents clinical and logistical challenges, including missing
alterations, insufficient tissue for testing, and a significant loss of
precious time in identifying a clinical course of care," said Andrew
Pecora, M.D., F.A.C.P., C.P.E., member of Regional Cancer Care
Associates and chief innovation officer, Professor and vice president of
Cancer Services, John Theurer Cancer Center at HackensackUMC. "The
availability of a single CGP assay to accurately identify all known
variants from a single sample and to accommodate the expanding list of
genomic markers in metastatic NSCLC without necessitating new biopsies
is a medical necessity."
"Horizon believes in investigating whether a comprehensive genomic
approach could yield the most robust information to guide clinical
treatment options - either to approved or investigational therapies -
through clinical trials," said Glenn D. Pomerantz, M.D., JD, vice
president and chief medical officer with Horizon. "Ultimately, we hope
that working with Foundation Medicine on this approach will optimize
outcomes for metastatic lung cancer patients."
Patients will be enrolled at Regional Cancer Care Associates (RCCA) and
Hackensack Medical University in New Jersey. Patient outcomes will be
tracked by Clinical Outcomes Tracking and Analysis (COTA). Horizon Blue
Cross of New Jersey will pay for enrolled patients to receive
FoundationOne assays as part of the study.
About COTA, Inc.
Developed by world-leading oncologists, COTA, Inc. has developed the
unique CNA (COTA Nodal Address) System to precisely classify cancer
patients into meaningful clinical and prognostic cohorts. Using this
sorting technique, COTA is able to account for the biologic variances of
cancer, thus permitting more in-depth analyses of treatment
variances. This enables doctors and health plans to improve patient care
and move from fee-for-service to value-based reimbursement models. COTA
offers providers, patients and payers with the actionable, real-time
insights needed to improve clinical outcomes, while reducing the costs.
Based in New York City, the Company's mission is to enable optimal care
for every cancer patient. To learn more about COTA, call (866) 648-3833
or visit www.oncota.com.
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's clinical assays,
FoundationOne® for solid tumors and FoundationOne® Heme for hematologic
malignancies and sarcomas, provide a comprehensive genomic profile to
identify the molecular alterations in a patient's cancer and match them
with relevant targeted therapies 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).
About Horizon Healthcare Services, Inc.
Horizon Healthcare Services, Inc., New Jersey's oldest and largest
health insurer, is a tax-paying, not-for-profit health services
corporation, providing a wide array of medical, dental, and prescription
insurance products and services. Horizon Healthcare Services, Inc.
serves 3.8 million members with headquarters in Newark and offices in
Wall, Mt. Laurel, and West Trenton. Learn more at www.HorizonBlue.com.
About Regional Cancer Care Associates
Regional Cancer Care Associates (RCCA), the largest oncology physician
network in New Jersey, is transforming oncology care by ensuring
patients and their caregivers are an active part of the treatment team
in all aspects of the management of their disease in a way that is
life-enriching and respectful. Regional Cancer Care Associates extends
across New Jersey with more than 90 cancer care specialists, growing to
include more than 100, and is supported by 600 employees at 27 care
delivery sites, providing care to more than 20,000 new patients annually
and over 230,000 existing patients. For more information, visit www.regionalcancercare.org.
Foundation Medicine® and FoundationOne®
are registered trademarks of Foundation Medicine, Inc.
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. 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
clinical study is delayed, discontinued or is not otherwise successfully
completed; that the outcomes from the clinical trial are not positive
and do not support the hypotheses developed by the study sponsors; that
the outcomes to do not provide sufficient support for Horizon to provide
its members with coverage for FoundationOne; and the risks described
under the caption "Risk Factors" in Foundation Medicine's Quarterly
Report on Form 10-Q for the quarter ended March 31, 2015, 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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Pure Communications, Inc.
Kim Brown, 617-418-2215
Source: Foundation Medicine
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