Myriad Genetics Launches the EndoPredict® Test in the United States for Patients with Breast Cancer
March 13 2017 - 7:05AM
Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular
diagnostics and personalized medicine, today announced that it has
launched the EndoPredict® test in the United States for patients
with ER+ HER2- early-stage breast cancer. EndoPredict is a
second-generation test for assessing the 10-year risk of disease
recurrence following surgery and for determining which patients can
safely forgo adjuvant chemotherapy.
“Today’s launch strengthens our oncology product portfolio and
represents a meaningful advancement in the treatment of patients
with breast cancer,” said Lloyd Sanders, general manager, Oncology,
Myriad Genetic Laboratories. “Along with our best-in-class
tests for hereditary cancer and our companion diagnostics, the
launch of EndoPredict underscores our commitment to pioneering
science, personalized medicine and patient care.”
EndoPredict is supported by multiple prospective clinical
studies and data from more than 3,500 patients with ER+ HER2- node
negative and node positive early-stage breast cancer. The
results of the clinical development program show that EndoPredict
substantially outperforms the first generation breast cancer
recurrence tests. EndoPredict was trained and validated using
10-year outcomes data and includes proliferation-related genes as
well as hormone receptor-related genes, providing accurate
assessment of early and late risk for recurrence and definitively
classifies patients as low or high risk.
“Breast cancer is a complicated disease and there is a
critical need for accurate breast cancer recurrence tests that help
physicians determine which patients can safely forgo adjuvant
chemotherapy,” said Johnathan Lancaster, M.D., Ph.D., chief medical
officer, Myriad Genetic Laboratories. “The launch of
EndoPredict is an important advancement for patients and doctors.
By automatically incorporating clinical features and
generating an individualized patient test result, EndoPredict
identifies a larger subset of true low-risk patients who may safely
forgo adjuvant chemotherapy."
EndoPredict already is included in medical guidelines including
the American Society of Clinical Oncology (ASCO), European Society
of Medical Oncology (ESMO) and the St. Gallen International Breast
Conference. Additionally, the Integrated Oncology Network
(ION) named EndoPredict as its preferred breast cancer recurrence
test. Myriad is working with payers to making sure
EndoPredict is a widely accessible to patients. So far, the
test has received positive coverage decisions from 19 payers,
bringing total coverage to over 70 million patients in the United
States.
Follow Myriad on Twitter via @MyriadGenetics and stay informed
about Company news and updates.
Clinical Data Supporting the Launch
Name of Trial |
# of Patients |
Breast Cancer Sub-Type |
Nodal Status |
10-Year Distant Metastasis Rate for Low
Risk Group |
Multicenter |
964 |
ER+/HER2- |
NO, N+ |
7.0 |
% |
ABCSG-6 |
378 |
ER+/HER2- |
NO, N+ |
4.0 |
% |
ABCSG-8 |
1,324 |
ER+/HER2- |
NO, N+ |
4.0 |
% |
ATAC |
928 |
ER+/HER2- |
NO, N+ |
5.8 |
% |
About Breast CancerBreast cancer is the second
leading cause of mortality among women. A woman living in the
United States has a 12.3 percent, or a 1 in 8, lifetime risk of
being diagnosed with breast cancer. In 2017, invasive breast
cancer will be diagnosed in more than 246,660 women.
About EndoPredictEndoPredict is a
second-generation, multigene test designed to predict disease
recurrence in patients diagnosed with breast cancer. The test
provides physicians with information to develop personalized
treatment plans for their patients. EndoPredict has been
validated in approximately 3,500 patients with node-negative and
node-positive cancer and has been used clinically in over 13,000
patients. EndoPredict was trained and validated using 10-year
outcomes data and includes proliferation-related genes as well as
hormone receptor-related genes providing an accurate assessment of
early and late risk for recurrence. Therefore, therapy decisions
backed by EndoPredict confer a high level of diagnostic safety. For
more information, please visit: www.endopredictusa.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: transitioning and expanding its
hereditary cancer testing markets, 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, myPath, myRisk, Myriad myRisk, myRisk Hereditary Cancer,
myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx,
myChoice HRD, EndoPredict, Vectra, GeneSight 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.
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 the launch of the EndoPredict test
in the United States for patients with ER+ HER2- early-stage breast
cancer; the ability of EndoPredict to assess the 10-year risk of
disease recurrence following surgery; the ability of EndoPredict to
identify a larger subset of true low-risk patients who may safely
forgo adjuvant chemotherapy; EndoPredict providing more
accurate 10-year risk for patients diagnosed with ER+ HER2-
early-stage breast cancer; the ability of EndoPredict to
determine which patients can safely forgo adjuvant chemotherapy;
EndoPredict substantially outperforming the first generation breast
cancer recurrence tests; the extent of positive coverage decisions
for EndoPredict and the Company’s work with payers to make sure
EndoPredict is widely accessible to patients; therapy decisions
backed by EndoPredict conferring a high level of diagnostic safety;
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
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 our 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 Annual report on Form 10-K for the fiscal year ended
June 30, 2016, 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
(801) 584-3065
rrogers@myriad.com
Investor Contact:
Scott Gleason
(801) 584-1143
sgleason@myriad.com
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