The EndoPredict® Test Receives Positive Coverage Decisions from Multiple Blue Cross Blue Shield Affiliate Plans
January 06 2017 - 7:05AM
Myriad Genetics, Inc. (NASDAQ:MYGN), a global leader in
personalized medicine, today announced that multiple Blue Cross
Blue Shield (BCBS) affiliate plans have issued positive coverage
determinations for EndoPredict®, including Independence Blue Cross,
Blue Cross and Blue Shield of Kansas, Blue Cross and Blue Shield of
Kansas City, Horizon Blue Cross Blue Shield of New Jersey and
BlueCross BlueShield of South Carolina. These five BCBS plans
provide coverage for an additional 12 million patients in the
United States. EndoPredict is a second-generation, multigene
test that is designed to predict disease recurrence in patients
diagnosed with breast cancer.
“We are excited to see that payers are increasingly
recognizing the level and quality of clinical evidence supporting
the EndoPredict test for patients with breast cancer,”
said Johnathan M. Lancaster, M.D., Ph.D., chief medical
officer, Myriad Genetic Laboratories. “EndoPredict ‘markedly
outperformed’ the first-generation test in a large, head-to-head
study recently presented at the San Antonio Breast Cancer Symposium
in December. We are confident that EndoPredict will provide
improved health outcomes and value for both patients and
payers.”
These coverage decisions follow a recent positive
review by Evidence Street, which provides technical assessments of
medical technologies for the Blue Cross Blue Shield
Association. Affiliated plans of the Association insure one
in three Americans. Evidence Street’s review found that the
EndoPredict test results in a meaningful improvement in the net
health outcomes in node-negative breast cancer patients.
In aggregate, payers in the United States now cover
the EndoPredict test for more than 32 million patients. Myriad
previously announced plans to launch EndoPredict in the United
States in the first half of calendar year 2017. EndoPredict
is marketed outside the United States and has been used to guide
treatment selection in more than 13,000 patients.
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 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 the first-generation multigene
prognostic test (i.e., Oncotype Dx), 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.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 StatementThis press
release contains “forward-looking statements” within the meaning of
the Private Securities Litigation Reform Act of 1995, including
statements relating to receiving coverage for the EndoPredict test
from several health insurance providers in the Blue Cross Blue
Shield affiliate network; the EndoPredict resulting in a meaningful
improvement in the net health outcomes in node-negative breast
cancer patients, consistent with the level of evidence used to
support coverage of the first-generation test; the number of
additional patient lives covered by these five BCBS plans in the
United States; the number of patient lives now covered by payers in
the United States for the EndoPredict test; EndoPredict testing
providing improved health outcomes and value for both patients and
payers; the Company’s plans to launch the EndoPredict test in the
United States in the first half of calendar year 2017; 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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