Myriad’s myPath® Melanoma Test Receives Medicare Coverage
March 14 2019 - 8:01AM
Myriad Genetics, Inc. (NASDAQ: MYGN), a global leader in
personalized medicine, today announced that the Medicare
Administrative Contractor Palmetto GBA MolDx has issued a
final local coverage determination (LCD) for the myPath®
Melanoma test to help physicians provide a definitive diagnosis
when a suspicious skin lesion is equivocal based upon
histopathology.
“We are excited that Palmetto has reviewed the extensive
clinical dossier for the myPath Melanoma test and decided to cover
the test for Medicare patients,” said Vicki Fish, vice president of
Dermatology, Myriad Genetics. “We look forward to making the
myPath Melanoma test accessible to more patients so that they can
obtain a definitive diagnosis and receive appropriate treatment and
better health outcomes.”Melanoma is one of the fastest growing
cancers in the United States and can strike people of all ages,
races and skin types. More than one million skin biopsies are
performed annually and approximately 15 percent of patients have an
equivocal skin lesion. The myPath Melanoma test analyzes 23
genes and has proven to be highly accurate in multiple studies at
distinguishing melanoma from benign moles (nevi). ”There is
strong demand among physicians for an objective genetic test to be
used as an adjunct to historical approaches for diagnosis,” said
Loren Clarke, M.D., board certified dermatopathologist and medical
director, Dermatology, Myriad Genetics. “The myPath Melanoma
test has enormous potential to help patients because an appropriate
treatment plan begins with an accurate and definitive
diagnosis.”Follow Myriad on Twitter via @MyriadGenetics to stay
informed about news and updates about myPath Melanoma.
About MelanomaAccording to the American Cancer
Society, approximately 96,480 Americans are expected to be
diagnosed with melanoma this year. Early and accurate
diagnosis of melanoma is critical for long-term survival.
About Myriad
myPath® Melanoma
Myriad myPath Melanoma is a clinically validated test to be used as
an adjunct to histopathology when the distinction between a benign
nevus and a malignant melanoma cannot be made confidently by
histopathology alone. The test measures the expression of 23 genes
and accurately distinguishes melanoma from benign nevi. For
more information visit: www.mypathmelanoma.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
five strategic imperatives: build upon a solid hereditary
cancer foundation, growing new product volume, expanding
reimbursement coverage for new products, increasing RNA kit revenue
internationally and improving profitability with Elevate
2020. 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,
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.
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 the final LCD for the myPath® Melanoma test;
the ability of the myPath® Melanoma test to help physicians provide
a definitive diagnosis when a suspicious lesion is equivocal based
upon histopathology; making the myPath Melanoma
accessible to more patients so that they can obtain an accurate
diagnosis, receive appropriate treatment and achieve the best
health outcomes; strong demand among physicians for an objective
genetic test to be used as an adjunct to historical approaches for
diagnosis; the myPath Melanoma test’s enormous potential to help
patients because an appropriate treatment plan starts with an
accurate and definitive diagnosis; 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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