Myriad Genetics, Inc. (NASDAQ: MYGN), a global leader in
personalized medicine, today announced that the
EndoPredict
® test (EPclin) identifies women with
early-stage breast cancer who can safely forgo extended endocrine
therapy five years after diagnosis. Findings from the study
were published in the journal Clinical Cancer Research.
“Women with early-stage breast cancer face a critical treatment
decision five years after diagnosis, which is whether or not to
extend their endocrine therapy,” Ralf Kronenwett, M.D., Ph.D.,
director of International Medical Affairs, Myriad Genetics.
“With the EndoPredict test, we can use a biomarker to help answer
that important question, which may improve health outcomes for
women and reduce costs for healthcare systems.”
The newly published study assessed the ability of the
EndoPredict (i.e., EPclin) test to predict early distant recurrence
(0-10 years) and late recurrence (5-15 years) of breast cancer,
according to nodal status. The analysis included 1,702
patients with early-stage ER-positive, HER2-negative breast cancer
who received five years of endocrine therapy alone. Overall,
62.6 percent of patients had low EndoPredict scores (i.e.,
<3.3). Women with low EndoPredict scores had a
statistically significantly reduced risk of distant recurrence
compared to those with high scores (Graph 1). Importantly,
EndoPredict was highly predictive of both early and late distant
recurrence (DR) in both node-negative and node-positive
women.
Graph 1: Women with Low EPclin Scores May
Decide to Forgo Extended Endocrine Therapy
http://www.globenewswire.com/NewsRoom/AttachmentNg/76756dbf-741b-4de3-82bc-8fd835b7c8d2
“In this study, we demonstrated that women with a high
EndoPredict test score are at significantly increased risk of a
breast cancer recurrence setback compared to those with a low
score,” said Martin Filipits, Ph.D., principle investigator,
Institute of Cancer Research, Breast Health Center and
Comprehensive Cancer Center, Medical University of Vienna Head of
ABCSG Research. “Importantly, between 5 and 15 years after
diagnosis, only four percent of women in the low-risk group
experienced a recurrence, compared to 16 percent in the high-risk
group. This suggests that EndoPredict can be used to help
select patients with low risk disease, who can safely discontinue
endocrine therapy at five years.”
Last month, Myriad published a separate study in the journal
Breast Cancer Research and Treatment which demonstrated that the
EndoPredict test accurately predicts which women with early-stage
ER-positive, HER2-negative breast cancer will benefit from adjuvant
chemotherapy.
“Women with ER-positive, HER2-negative breast cancer face three
critical questions: What is my risk of disease recurrence in the
next 15 years?, Do I need adjuvant chemotherapy following my
diagnosis?, and Can I discontinue endocrine therapy at the 5-year
mark?,” said Johnathan Lancaster, M.D., Ph.D., chief medical
officer, Myriad Genetics. “EndoPredict is the only breast
cancer test that answers these questions in a single and affordable
offering. It’s one test, three answers. And, nearly all
insurance plans in the United States now cover EndoPredict for
their members, which is confirmation that we are delivering
substantial value to payers.”
About Breast CancerOne in eight American women
will have breast cancer during her lifetime. Breast cancer is the
second leading cause of cancer death among American women.
The American Cancer Society estimates in its Cancer Facts
& Figures 2019 report that more than 268,000 women will be
told they have breast cancer in 2019. The World Health
Organization estimates the incidence of breast cancer diagnoses in
the European Union to be more than 400,000 annually.
About EndoPredict®EndoPredict
is a second-generation, prognostic test that aids personalized
treatment planning for patients with early-stage breast
cancer. EndoPredict has been validated in over 3500 patients
with node-negative and node-positive disease and is the leading
breast prognostic in Europe. In contrast to first-generation
multigene prognostic tests, EndoPredict incorporates a 12-gene
molecular score with known prognostic factors tumor size and nodal
status. In clinical studies, EndoPredict demonstrated its
robust ability to predict recurrence risk across multiple
time-periods: 0-5, 5-10, and 5-15 years. EndoPredict provides
clinically actionable information to physicians and patients as
they consider the use of adjuvant chemotherapy and extended
endocrine therapy.
About Myriad GeneticsMyriad 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 critical success factors: build upon a solid hereditary
cancer foundation, grow new product volume, expand reimbursement
coverage for new products, increase RNA kit revenue internationally
and improve profitability with Elevate 2020.
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.
Safe Harbor StatementThis press release
contains "forward-looking statements" within the meaning of the
Private Securities Litigation Reform Act of 1995, including
statements related to clinicians being able to identify women with
early-stage breast cancer who can safely forgo extended endocrine
therapy five years after diagnosis; the use of EndoPredict test as
a biomarker to help answer important questions, or improve
health outcomes for women and reduce costs for healthcare systems;
the study demonstrating that women with a high EndoPredict test
score are at significantly increased risk of a breast cancer
recurrence setback compared to those with a low score;
EndoPredict’s use to help select patients with low risk disease,
who can safely discontinue endocrine therapy at five years; nearly
all insurance plans in the United States covering EndoPredict for
their members; confirmation that the company is delivering
substantial value to payers; 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.
Media Contact: Ron
Rogers
Investor Contact: Scott
Gleason
(801) 584-3065
(801)
584-1143
rrogers@myriad.com
sgleason@myriad.com
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