Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular
diagnostics and personalized medicine, today announced new positive
results for EndoPredict®, a second-generation prognostic gene
expression test for breast cancer. The study found that
EndoPredict (EPclin) was superior to the first-generation Oncotype
DX Breast Recurrence Score® (RS) in predicting breast cancer
recurrence in women determined to be at intermediate clinical risk
by Nottingham Prognostic Index. The data will be presented at
the 3rd World Congress on Controversies in Breast Cancer (CoBrCa)
being held Oct. 26-28, 2017 in Tokyo, Japan.
This is the second head-to-head study to show that EndoPredict
significantly outperformed the first-generation prognostic test for
breast cancer, especially for predicting the distant recurrence of
breast cancer, and underscores Myriad’s unwavering commitment to
advancing precision medicine for women with breast cancer.
The first study was published in the Journal of the National Cancer
Institute (JNCI) in July 2016.
“This new study is further evidence that compared to the first
generation test, EndoPredict more effectively predicts the
recurrence of breast cancer up to 10 years after diagnosis in women
with ER+, HER2- breast cancer,” said Ivana Sestak, Ph.D., principal
investigator, Centre for Cancer Prevention, Wolfson Institute of
Preventive Medicine, Queen Mary University of London. “These
findings will help physicians personalize treatment for women with
an intermediate clinical risk of recurrence by identifying those
patients who need adjuvant chemotherapy following surgery.”
Oral Presentation.Title:
Comparison of prognostic performance of Oncotype Dx Recurrence
Score versus EndoPredict (EPclin) in women with intermediate risk
of recurrence by Nottingham Prognostic
Index.Presenter: Ivana Sestak,
Ph.D.Date: Friday, Oct. 27 3:30 to 4:30
p.m.Programme Number: OR01.
The analysis included 387 women with ER-positive, HER2-negative
breast cancer and who were determined to be at intermediate risk of
recurrence as defined by the Nottingham Prognostic Index
(NPI). The primary endpoint was distant recurrence and the
primary objective was to assess the value of EndoPredict (EPclin)
for the prediction of (late) distant recurrence and compare the
results to Oncotype Recurrence Score (RS).
This study showed that EndoPredict markedly outperformed
Oncotype across the 10-year follow-up period with prognostic power
more than two times higher (EPclin: LRX2= 14.1; RS: LRX2=5.9).
In this analysis, EndoPredict stratified 149 (38.5 percent)
women into the low risk group and 238 (61.5 percent) into the high
risk group. A highly significant separation between the
groups was observed. The 10-year distant recurrence (DR) was
12.5 percent for the low risk group vs. 25.9 percent for the high
risk group (HR=2.42). However, for Oncotype, the DR rate was 16.3
percent for the low risk group and no clear separation between
intermediate and high risk groups was observed, with similar
10-year distant recurrence risks (24.2 vs. 27.3 percent,
respectively).
Additionally, for the prediction of late distant recurrence
(5-10 years), EndoPredict provided significant prognostic value in
this time period and identified 136 (40.2 percent) patients as low
risk and 202 (59.8 percent) as high risk, while the first
generation test did not provide prognostic value for late
metastasis for women deemed intermediate risk of recurrence by
NPI. These results confirm the importance of the inclusion of
clinicopathological data to achieve best prognostication in this
patient group.
Follow Myriad on Twitter via @MyriadGenetics and stay informed
about symposium news and updates by using the hashtag #CoBrCa.
About EndoPredictEndoPredict is a
second-generation, multigene prognostic test for patients diagnosed
with breast cancer. The test provides physicians with
information to devise personalized treatment plans for their
patients. EndoPredict has been validated in approximately
4,000 patients with node-negative and node-positive cancer and has
been used clinically in over 13,000 patients. In contrast to
first-generation multigene prognostic tests, EndoPredict detects
the likelihood of late metastases (i.e., metastasis formation after
more than five years) and, therefore, can guide treatment decisions
regarding the need for chemotherapy, as well as extended
anti-hormonal therapy. Accordingly, therapy decisions backed by
EndoPredict confer a high level of diagnostic safety. For more
information, please visit: www.endopredict.com.
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
three strategic imperatives: maintaining leadership in an
expanding hereditary cancer market, diversifying its product
portfolio through the introduction of new products and increasing
the revenue contribution from international markets. 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, EndoPredict, myPath, myRisk, Myriad myRisk, myRisk Hereditary
Cancer, myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx,
myChoice HRD, Vectra DA, GeneSight, EndoPredict and Prolaris 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 and Oncotype DX Breast Recurrence Score are
registered trademarks 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 relating to related to the study data to be
presented at the 3rd World Congress on Controversies in
Breast Cancer (CoBrCa) being held Oct. 26-28, 2017 in Tokyo, Japan;
the study findings that EndoPredict (EPclin) was superior to the
first-generation tests in predicting breast cancer recurrence in
women determined to be at intermediate clinical risk by Nottingham
Prognostic Index; EndoPredict testing more effectively predicting
the recurrence of breast cancer up to 10 years after diagnosis in
women with ER+, HER2- breast cancer; the study results helping
physicians personalize treatment for women with an intermediate
clinical risk of recurrence by identifying those patients who need
adjuvant chemotherapy following surgery; and the Company’s
strategic directives under the captions “About EndoPredict” and
“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
described or implied in the forward-looking statements. These risks
include, but are not limited to: the risk that sales and profit
margins of our existing molecular diagnostic tests and
pharmaceutical and clinical services may decline or will not
continue to increase at historical rates; risks related to our
ability to transition from our existing product portfolio to our
new tests; risks related to changes in the 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 tests and any future tests are terminated or cannot be
maintained on satisfactory terms; risks related to delays or other
problems with operating our laboratory testing facilities; 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, including
but not limited to our acquisition of Assurex, Sividon and the
Clinic; risks related to our projections about the potential market
opportunity for our products; 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; 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, 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.
Media Contact: |
Ron Rogers |
Investor Contact: |
Scott Gleason |
|
(801) 584-3065 |
|
(801) 584-1143 |
|
rrogers@myriad.com |
|
sgleason@myriad.com
|
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