EndoPredict® Receives Positive Coverage Decisions From Medicare and Anthem
August 17 2017 - 4:15PM
Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular
diagnostics and personalized medicine, announced today that
Palmetto GBA, the Medicare contractor who oversees the MolDx
program and Anthem, Inc., one of the largest private insurers in
the country, have announced positive coverage decisions for
EndoPredict® testing.
“We now have nearly full coverage for EndoPredict testing in the
United States which was accomplished in an unprecedented time of
less than six months after our launch,” said Mark C. Capone,
president and CEO, Myriad Genetics. “We believe this rapid
expansion of coverage reflects the strong scientific evidence and
compelling head-to-head data where the EndoPredict test markedly
outperformed the leading first-generation test, and the value of
avoiding frustrating and costly intermediate results.”
Following the full implementation of these decisions, Myriad
will now have coverage for over 90 percent of breast cancer
patients.
“We are seeing increased physician interest in EndoPredict
testing and broad reimbursement only strengthens their conviction
to use a second generation test with clear superiority in
predicting recurrence in the critical five to ten year timeframe,”
said Johnathan Lancaster M.D., Ph.D., chief medical officer, Myriad
Genetics.
About EndoPredictEndoPredict is a
next-generation, multigene prognostic test for patients diagnosed
with breast cancer. The test provides physicians with
information to devise personalized treatment plans for their
patients with breast cancer. EndoPredict has been validated
in approximately 4,000 patients with node-negative and
node-positive cancer and has been used clinically in over 15,000
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: 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 the positive coverage decisions by Palmeto
GBA and Anthem, Inc. for the EndoPredict test and the timing for
full implementation of these decisions; our having nearly full
coverage for EndoPredict testing in the United States; the
reflected reasons for our rapid expansion of coverage of the
EndoPredict test; the degree of coverage for breast cancer
patients; the increased physician interest in EndoPredict testing
and broad reimbursement strengthening physician use of EndoPredict
testing; the superiority in predicting recurrence in the critical
five to ten year timeframe; 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, 2017, 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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