Myriad Publishes myPath(TM) Melanoma Pivotal Validation Study in the Journal of Cutaneous Pathology
March 04 2015 - 7:05AM
Myriad Genetics, Inc. (Nasdaq:MYGN) today announced the Journal of
Cutaneous Pathology published data from a pivotal clinical
validation study that showed the myPath™ Melanoma test is highly
effective at differentiating benign skin moles from malignant
melanoma with greater than 90 percent diagnostic accuracy.1
Melanoma is the most dangerous type of skin cancer and more than
76,000 new cases of melanoma are diagnosed each year in the United
States.
"Conventional methods of differentiating benign moles from
melanoma are effective for many cases, but there is no
one-size-fits-all approach. About 15 percent of cases are difficult
or impossible to diagnose using standard tools, which can lead to
undesirable outcomes such as untreated melanoma, unnecessary
treatment or psychological distress," said Loren Clarke, M.D.,
medical director for Dermatology at Myriad. "myPath Melanoma is a
powerful new molecular diagnostic test that analyzes genetic
information inside skin cells to help us understand the biology of
a patient's skin lesion and objectively differentiate benign moles
from potentially lethal melanoma."
The published study describes the discovery, verification and
clinical validation of the myPath Melanoma test, which was designed
to differentiate benign moles from malignant melanoma. The
myPath Melanoma test was developed using a verification cohort of
464 patient samples and was validated in a separate independent
study with 437 patient samples from leading academic medical
centers in the United States. In both the verification and
validation studies, the myPath Melanoma test demonstrated a greater
than 90 percent diagnostic accuracy, making it the most accurate
molecular diagnostic test developed to date for
melanoma. These clinical findings validate the performance,
objectivity and reliability of the myPath Melanoma test for
clinical use to improve the diagnosis of melanoma.
"The myPath Melanoma study results confirm the test's potential
to more objectively differentiate between benign lesions and
malignant melanoma than current evaluation practices," said Sancy
Leachman. M.D., Ph.D., one of the study's lead investigators and
director of the Melanoma Research Program, Knight Cancer Institute,
Oregon Health & Science University. "The study results
validate the promise of molecular diagnostics in improving the
precision of cancer treatment."
About Myriad myPath Melanoma
Testing
Myriad myPath Melanoma is a clinically validated gene expression
test designed to differentiate malignant melanoma from benign nevi
across all major melanoma subtypes. Myriad myPath Melanoma is
a unique test of 23 genes that provides valuable, additive
diagnostic information unavailable from any other method –
information that can help physicians deliver a more confident
diagnosis.
Melanoma is the most serious type of skin cancer. According to
the American Cancer Society, about 76,000 new melanomas are
diagnosed each year and more than 9,000 people die from the disease
annually. Each year in the United States, there are approximately
1.5 million skin biopsies performed specifically for the diagnosis
of melanoma, and approximately 15 percent, or 225,000 biopsies, are
classified as indeterminate, meaning that the dermatopathologist
cannot confidently determine whether the cells are benign or
malignant. For more information visit:
http://www.isthismelanoma.com and
www.myriadpro.com/melanoma.
About Myriad Genetics
Myriad Genetics is a leading molecular diagnostic company
dedicated to making a difference in patients' lives through the
discovery and commercialization of transformative tests to assess a
person's risk of developing disease, guide treatment decisions, and
assess risk of disease progression and recurrence. Myriad is
focused on strategic initiatives to grow existing markets,
diversify through the introduction of new products, including
companion diagnostics, and expand internationally. 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, myRisk Hereditary Cancer, myChoice, myPlan Lung
Cancer, BRACAnalysis CDx, HRD, Vectra and Prolaris are trademarks
or registered trademarks of Myriad Genetics, Inc. 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 related to the effectiveness of Myriad
myPath Melanoma testing to accurately differentiate malignant
melanoma from benign lesions and help physicians deliver a more
objective and confident diagnosis; the Company's belief that the
Myriad myPath Melanoma test represents a significant advancement in
the prompt and accurate diagnosis of potentially fatal melanoma;
the clinical use of the Myriad myPath Melanoma test as an adjunct
to standard pathology techniques in the evaluation of pigmented
skin lesions, particularly in difficult-to-classify cases; the
Company's belief that the Myriad myPath Melanoma test will
substantially improve the standard of care for patients with
melanoma; and the Company's strategic initiatives under the caption
"About Myriad Genetics." 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 or will not continue to increase at
historical rates; risks related to our ability to transition from
our existing single cancer tests to our new cancer panel tests,
including unexpected costs and delays; risks related to decisions
or 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 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; 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; 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
or covering patents or enforcement in the United States and foreign
countries generally; risks of new, changing and competitive
technologies and regulations in the United States and
internationally; 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, 2014, 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.
1 Clarke L, Warf M, Flake D, et al: Clinical validation of a
gene expression signature that differentiates benign nevi from
malignant melanoma. J Cutan Pathol. 2015. Available
online at
http://onlinelibrary.wiley.com/doi/10.1111/cup.12475/abstract
CONTACT: Media Contact:
Ron Rogers
(801) 584-3065
rrogers@myriad.com
Investor Contact:
Scott Gleason
(801) 584-1143
sgleason@myriad.com
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