Myriad Genetics, Inc. (NASDAQ: MYGN), a global leader in
personalized medicine, today announced an international team of
cancer researchers has found that EndoPredict
®
test accurately predicts which women with ER-positive,
HER2-negative breast cancer will benefit from adjuvant
chemotherapy. Findings from the study were published today in
the journal Breast Cancer Research and Treatment.
"We are excited to publish our findings because ER-positive,
HER2-negative breast cancer is the most common type of breast
cancer, and a key goal is identifying which women need endocrine
therapy alone and which need endocrine therapy plus chemotherapy to
get the best possible outcomes,” said William J. Gradishar, M.D.,
one of the study’s authors and chief of hematology and oncology,
department of medicine, Betsy Bramsen Professorship of Breast
Oncology, and professor of medicine at Northwestern University's
Feinberg School of Medicine. “Our study demonstrated that the
EndoPredict test can accurately identify patients who are likely to
benefit from adjuvant chemotherapy. What this means is that
clinicians can use the EndoPredict test to personalize their care
by directing chemotherapy to women with a high likelihood of
benefit, while preventing the over-treatment of women who are
unlikely to benefit.”
This study evaluated the ability of the EndoPredict test
(EPclin) to predict chemotherapy benefit based on the analysis of
the 10-year distant recurrence rate (i.e., metastasized cancer) in
women with ER-positive, HER2-negative breast cancer who received
five years of endocrine therapy (ET) alone or in combination with
chemotherapy (ET+C). Data from 3,746 women (2,630 on ET alone
and 1,116 on ET+C) were included in the analysis. The study
found that women with a high EndoPredict score (i.e., >3.3) and
who received ET+C had significantly lower 10-year recurrence risk
than those on ET alone (Graph 1). However, there were no
significant differences between ET+C and ET for patients with low
EndoPredict scores, suggesting these women are unlikely to benefit
from adjuvant chemotherapy.
“In this analysis with modern chemotherapy regimens, patients
with a high EndoPredict test score who received endocrine therapy
and chemotherapy had significantly better outcomes than those
receiving endocrine therapy alone,” said Ivana Sestak, Ph.D.,
principle investigator, Centre for Cancer Prevention, Wolfson
Institute of Preventive Medicine, Queen Mary University of
London. “Based on these findings, oncologists should use the
EndoPredict test to make decisions about the best course of
treatment for their patients.”
Graph 1: EndoPredict® Predicts Chemotherapy
Benefit in Women with ER+, HER-Breast Cancer is available at
the following address:
http://www.globenewswire.com/NewsRoom/AttachmentNg/92035128-381e-4220-91c9-1e015196dfb4
“EndoPredict is an advanced precision medicine test, and is the
only test with the scientific rigor to provide superior
risk-stratification for patients with both node+/- breast cancer,
to identify those patients who can safely forgo extended endocrine
therapy after five years and importantly, predict chemotherapy
benefit,” said Johnathan Lancaster, M.D., Ph.D., chief medical
officer, Myriad Genetics. “EndoPredict is covered by nearly
all health insurers in the United States because they have
recognized the ability of EndoPredict to address unmet medical
needs, improve health outcomes for women and potentially save the
healthcare systems tens of millions of dollars.”
The EndoPredict test was recently included in The National
Comprehensive Cancer Network (NCCN) Guidelines for breast
cancer. Follow Myriad on Twitter via @MyriadGenetics to stay
informed about news and updates from the Company.
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.
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.
Oncotype Dx is a registered trademark of Genomic Health,
Inc.
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 use the EndoPredict
test to personalize their care by directing chemotherapy to women
with a high likelihood of benefit, while preventing the
over-treatment of women who are unlikely to benefit; oncologists
using the EndoPredict test to make decisions about the best course
of treatment for their patients; EndoPredict providing superior
risk-stratification for patients with both node+/- breast cancer,
identifying those patients can safely forgo extended endocrine
therapy after five years and predicting chemotherapy benefit; the
ability of EndoPredict to address unmet medical needs, improve
health outcomes for women and potentially save the healthcare
systems tens of millions of dollars; 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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