Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular
diagnostics and personalized medicine, today announced it will
present two new studies at the American Society of Dermatopathology
(ASDP) annual meeting being held Oct. 27-30, 2016 in Chicago,
Ill. The research being presented validates the accuracy of
Myriad myPath® Melanoma in differentiating benign skin nevi from
malignant melanoma.
“We are presenting landmark data from the largest outcomes-based
study ever performed with a melanoma diagnostic,” said Loren
Clarke, M.D., medical director, Dermatology, Myriad Genetic
Laboratories. “The myPath Melanoma test performed very well
and identified patients with melanoma versus benign skin lesions
with greater than 95 percent diagnostic accuracy, which is
exceptional in molecular diagnostics for cancer, particularly given
the extreme heterogeneity of melanoma.”
“Pigmented or suspect skin lesions are difficult to diagnose in
approximately 15 percent of cases,” said Sancy Leachman, M.D.,
Ph.D., chair of the Department of Dermatology in the Oregon Health
& Science University School of Medicine and director of the
Melanoma Research Program at the Knight Cancer Institute. “A
highly accurate biomarker like the myPath Melanoma test should help
dermatologists augment their diagnosis of melanoma, improve patient
care and lower healthcare costs.”
Below are the featured presentations at ASDP
(#ASDP2016).
Poster PresentationTitle:
Diagnostic Distinction of Malignant Melanoma and Benign Nevi by a
Gene Expression Signature and Correlation to Clinical
Outcome.Presenter: Jennifer
Ko.Date: Friday, Oct. 28, 2016: 4:15 – 5:00 p.m.
and Saturday, Oct. 29, 2016 10:00 – 10:45 a.m. CT.
In this study, research collaborators from the Cleveland Clinic,
Stanford University and Nottingham University assessed the clinical
accuracy (sensitivity and specificity) of the myPath Melanoma test
against clinical outcomes in 182 patients with skin lesions (99
melanomas and 83 nevi) with more than 5 years of follow up.
The results show that the myPath Melanoma test accurately
differentiated benign lesions from melanoma with a sensitivity of
93.8 percent and a specificity of 96.2 percent when compared to
known clinical outcomes. The diagnostic accuracy of the
myPath Melanoma test was high even in a subset of
difficult-to-diagnose cases and, in combination with two previous
validation studies, the findings support its use as an adjunct
method for the early and accurate diagnosis of melanoma.
Podium PresentationTitle: Gene
Expression Signature as an Ancillary Method in the Diagnosis of
Desmoplastic Melanoma.Presenter: Loren
Clarke.Date: Sunday, Oct. 30, 2016: 8:20 – 8:30
a.m. CT.
The objective of this study was to assess the accuracy of the
myPath Melanoma test in the differentiation of desmoplastic
melanoma (DM) from benign skin lesions. These lesions
represent approximately one percent of melanomas, but are known to
be very difficult to diagnose. The analysis included samples
from 20 patients with DM and 27 from patients with benign moles
(nevi). The results showed that the myPath Melanoma test was
positive in 15 of the 20 known melanomas, negative in four and
indeterminate in one. The myPath score was negative in 24 of
the benign nevi and indeterminate in three. Based on these
findings, the myPath Melanoma test demonstrated approximately 80
percent diagnostic accuracy in this very difficult-to-diagnose
subtype.
For more information about the meeting, please visit the ASDP
website at https://www.asdp.org/annual-meeting/home/. Follow
Myriad on Twitter via @MyriadGenetics to stay informed about news
and updates from the Company.
About MelanomaMelanoma is one of the fastest
growing cancers in the United States and can strike people of all
ages, races and skin types. With a one-in-50 lifetime risk of
developing melanoma, nearly 76,000 Americans are expected to be
diagnosed with Stage I-IV melanoma and another 68,000 will be
diagnosed with melanoma in situ – totaling approximately
144,000 total diagnoses. Early and accurate diagnosis of
melanoma is critical for long-term survival. For more
information visit: www.mypathmelanoma.com/ and
www.myriadpro.com/melanoma.
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.
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, EndoPredict, myPath, myRisk, Myriad myRisk, myRisk Hereditary
Cancer, myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx,
myChoice HRD, Vectra, Prolaris and GeneSight 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 Company presenting two new studies at
the American Society of Dermatopathology Annual Meeting being held
Oct. 27-30, 2016 in Chicago, Ill.; the accuracy and effectiveness
of Myriad myPath Melanoma testing in differentiating benign skin
nevi from malignant melanoma; and the Company’s strategic
directives under the captions “About Myriad myPath Melanoma” and
“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
and uncertainties 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, including unexpected costs and delays; 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 a
healthcare clinic in Germany and Sividon Diagnostic and our planned
acquisition of Assurex Health; risks related to our projections
about our business, results of operations and financial condition;
risks related to 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; 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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