Myriad Announces Publication of First Comprehensive Economic Study Demonstrating Cost Effectiveness of EndoPredict® for Bre...
June 25 2019 - 7:05AM
Myriad Genetics, Inc. (NASDAQ: MYGN), a global leader in
personalized medicine, today announced that The Pharmacogenomics
Journal published the results of the first comprehensive
cost-effectiveness analysis of the EndoPredict® test compared to
other breast cancer assays. The key finding is that EndoPredict
test was more than twice as cost effective as Oncotype DX®. Breast
cancer is the most common cancer in women worldwide.
“Payers would benefit from understanding the
financial implications of using gene expression tests to determine
recurrence risk in women with early-stage breast cancer,” said
Malek B. Hannouf, Ph.D., lead investigator, London Health Sciences
Centre, Ontario, Canada. “Our study provides firm evidence
validating the economic value of incorporating EndoPredict into
patient care.”
This study examined the cost effectiveness of
incorporating gene expression testing into standard practice using
data from the Anastrozole or Tamoxifen Alone or Combined (ATAC)
clinical trial and cost data from the London Regional Cancer
Program and other Canadian sources. The analysis evaluated three
genetic tests compared to the clinicopathological (CP) features
traditionally used to guide adjuvant treatment decisions. The
primary endpoint was quality adjusted life years (QALY), which is a
measure of the value of health outcomes. The results show that
compared to the CP predictors alone-based strategy, EndoPredict was
the single most cost-effective genetic test ($36,274/QALY) and was
more than twice as cost effective as the market leading Oncotype DX
test ($74,911/QALY).
“These results advance our understanding of
precision medicine for women with breast cancer and confirm that
EndoPredict is the most cost effective genetic test,” said Ralf
Kronenwett, M.D., Ph.D., director of International Medical Affairs,
Myriad Genetics. “The findings build on prior studies that
demonstrated the clinical utility EndoPredict for predicting which
women will benefit from adjunctive chemotherapy at diagnosis and
who is unlikely to benefit from extended endocrine therapy five
years after diagnosis.”
About
EndoPredict®
EndoPredict is a second-generation, multigene
prognostic test that aids personalized treatment planning for
patients with early-stage breast cancer. EndoPredict has been
validated in approximately 4,000 patients with node-negative and
node-positive disease and has been used clinically in more than
25,000 patients. In contrast to first-generation multigene
prognostic tests, EndoPredict is validated to accurately predict
both early (0-5) and late (5-15 years) distant recurrence and for
prediction of benefit from both adjuvant chemotherapy as well as
which patients can safely forgo extended endocrine therapy beyond
five years. EndoPredict is manufactured by Myriad Genetics,
Inc.
About Myriad Genetics
Myriad Genetics Inc., is a leading personalized
medicine company dedicated to being a trusted advisor transforming
patient lives worldwide with pioneering molecular diagnostics.
Myriad discovers and commercializes molecular diagnostic tests
that: determine the risk of developing disease, accurately diagnose
disease, assess the risk of disease progression, and guide
treatment decisions across six major medical specialties where
molecular diagnostics can significantly improve patient care and
lower healthcare costs. Myriad is focused on five strategic
imperatives: build upon a solid hereditary cancer foundation,
growing new product volume, expanding reimbursement coverage for
new products, increasing RNA kit revenue internationally and
improving profitability with Elevate 2020. For more information on
how Myriad is making a difference, please visit the Company's
website: www.myriad.com.
Myriad, the Myriad logo, BART, BRACAnalysis,
Colaris, Colaris AP, myPath, myRisk, Myriad myRisk, myRisk
Hereditary Cancer, myChoice, myPlan, BRACAnalysis CDx, Tumor
BRACAnalysis CDx, myChoice HRD, EndoPredict, Vectra, GeneSight,
riskScore, Prolaris, Foresight and Prequel are trademarks or
registered trademarks of Myriad Genetics, Inc. or its wholly owned
subsidiaries in the United States and foreign countries. MYGN-F,
MYGN-G.
Oncotype DX is a trademark of Genomic Health,
Inc.
Safe Harbor Statement
This press release contains “forward-looking
statements” within the meaning of the Private Securities Litigation
Reform Act of 1995, including statements relating to benefits to
payers from understanding the financial implications of using gene
expression tests to determine recurrence risk in women with
early-stage breast cancer; the economic value of incorporating
EndoPredict into patient care; and the Company's strategic
directives under the caption "About Myriad Genetics." These
"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
forward-looking statements. These risks and uncertainties include,
but are not limited to: the risk that sales and profit margins of
our molecular diagnostic tests and pharmaceutical and clinical
services may decline; risks related to our ability to transition
from our existing product portfolio to our new tests, including
unexpected costs and delays; risks related to decisions or changes
in governmental or private insurers’ reimbursement levels for our
tests or our ability to obtain reimbursement for our new tests at
comparable levels to our existing tests; risks related to increased
competition and the development of new competing tests and
services; the risk that we may be unable to develop or achieve
commercial success for additional molecular diagnostic tests and
pharmaceutical and clinical services in a timely manner, or at all;
the risk that we may not successfully develop new markets for our
molecular diagnostic tests and pharmaceutical and clinical
services, including our ability to successfully generate revenue
outside the United States; the risk that licenses to the technology
underlying our molecular diagnostic tests and pharmaceutical and
clinical services and any future tests and services are terminated
or cannot be maintained on satisfactory terms; risks related to
delays or other problems with operating our laboratory testing
facilities and our healthcare clinic; risks related to public
concern over genetic testing in general or our tests in particular;
risks related to regulatory requirements or enforcement in the
United States and foreign countries and changes in the structure of
the healthcare system or healthcare payment systems; risks related
to our ability to obtain new corporate collaborations or licenses
and acquire new technologies or businesses on satisfactory terms,
if at all; risks related to our ability to successfully integrate
and derive benefits from any technologies or businesses that we
license or acquire; risks related to our projections about our
business, results of operations and financial condition; risks
related to the potential market opportunity for our products and
services; the risk that we or our licensors may be unable to
protect or that third parties will infringe the proprietary
technologies underlying our tests; the risk of patent-infringement
claims or challenges to the validity of our patents or other
intellectual property; risks related to changes in intellectual
property laws covering our molecular diagnostic tests and
pharmaceutical and clinical services and patents or enforcement in
the United States and foreign countries, such as the Supreme Court
decision in the lawsuit brought against us by the Association for
Molecular Pathology et al; risks of new, changing and competitive
technologies and regulations in the United States and
internationally; the risk that we may be unable to comply with
financial operating covenants under our credit or lending
agreements; the risk that we will be unable to pay, when due,
amounts due under our credit or lending agreements; and other
factors discussed under the heading "Risk Factors" contained in
Item 1A of our most recent Annual Report on Form 10-K for the
fiscal year ended June 30, 2018, which has been filed with the
Securities and Exchange Commission, as well as any updates to those
risk factors filed from time to time in our Quarterly Reports on
Form 10-Q or Current Reports on Form 8-K. All information in this
press release is as of the date of the release, and Myriad
undertakes no duty to update this information unless required by
law.
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Media Contact: |
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Ron Rogers |
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Investor Contact: |
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Scott Gleason |
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(801) 584-3065 |
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(801) 584-1143 |
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rrogers@myriad.com |
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sgleason@myriad.com |
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