Myriad myPath(TM) Melanoma Test Improves the Reliability of Melanoma Diagnosis
June 02 2014 - 7:05AM
Myriad Genetics, Inc. (Nasdaq:MYGN) today presented results from a
pivotal clinical validation study of the Myriad myPath™ Melanoma
test at the 2014 American Society of Clinical Oncology (ASCO)
annual meeting in Chicago, Ill. The Myriad myPath Melanoma test is
a novel molecular test that accurately differentiates malignant
melanoma from benign skin lesions with a high level of accuracy and
helps physicians deliver a more objective and confident diagnosis
for patients.
"Unfortunately, some melanomas mimic benign skin lesions, making
them very difficult to diagnose and an uncertain result is
confusing for patients and clinicians. What we need is a new tool
to help us make a more definitive diagnosis," said Sancy Leachman,
M.D., Ph.D, chair of the Department of Dermatology at the Oregon
Health & Science University (OHSU) School of Medicine and
director of the Melanoma Research Program at the Knight Cancer
Institute. "In the validation study, Myriad myPath Melanoma was
shown to differentiate malignant melanoma from benign skin lesions
using traditional dermatopathology as a gold standard. This
represents a significant contribution toward making a prompt and
accurate diagnosis of potentially fatal melanoma."
The clinical validation study evaluated 437 pigmented lesions
(211 melanomas and 226 nevi) representing a broad spectrum of
subtypes submitted from four academic medical centers in the United
States. The clinical endpoint was the concordance of the Myriad
myPath Melanoma test to a consensus diagnosis from expert
dermatopathologists. In this study, the Myriad myPath Melanoma test
effectively differentiated malignant melanoma from benign skin
lesions with a sensitivity of 90 percent and a specificity of 91
percent. These results strongly support 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 Myriad myPath Melanoma test has now shown reproducible
results in two large cohorts. Last November, Myriad presented
results from its verification study at the American Society of
Dermatopathology annual meeting. Data from that verification
study of 464 lesions showed that the Myriad myPath Melanoma test
had greater than a 90 percent diagnostic accuracy in
differentiating malignant melanoma from benign skin lesions in a
variety of subtypes.
Additionally, an analysis of a prospective clinical utility
study was highlighted at ASCO and initial findings from that study
are consistent with earlier findings from a retrospective clinical
utility study that was presented at the United States &
Canadian Academy of Pathology's (USCAP) annual meeting in
March. The USCAP data demonstrated a 33 percent change in
medical management based upon the Myriad myPath Melanoma test
result.
"We believe the Myriad myPath Melanoma test will
substantially improve the standard of care for patients with
melanoma," said Loren Clarke, M.D., vice president of Medical
Affairs at Myriad Genetic Laboratories. "The Myriad myPath
Melanoma test objectively answers a vital clinical question for
healthcare providers: Does my patient have malignant melanoma that
requires surgical or medical intervention, or a harmless skin
lesion that only needs to be watched? The appropriate therapy
may differ drastically depending on the answer to that
question."
About Myriad myPath Melanoma
Testing
The Myriad myPath Melanoma test is a clinically validated gene
expression test designed to differentiate malignant melanoma from
benign nevi across all major melanoma subtypes. The Myriad
myPath Melanoma test 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 14 percent or 210,000 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's
molecular diagnostic tests are based on an understanding of the
role genes play in human disease and were developed with a
commitment to improving an individual's decision making process for
monitoring and treating disease. Myriad is focused on strategic
directives to introduce new products, including companion
diagnostics, as well as expanding internationally. For more
information on how Myriad is making a difference, please visit the
Company's website: www.myriad.com.
Myriad, the Myriad logo, Prolaris, Myriad myPath, Myriad myPlan
and Myriad myRisk 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 relating to the presentation of the
Myriad myPath Melanoma test clinical study data at the 2014 ASCO
Annual Meeting; the effectiveness of Myriad myPath 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 directives under the captions "About Myriad myPath
Melanoma Testing" and "About Myriad Genetics." These
"forward-looking statements" are management's present 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 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 companion diagnostic services may decline or
will not continue to increase at historical rates; risks related to
changes in the governmental or private insurers reimbursement
levels for our tests; the risk that we may be unable to develop or
achieve commercial success for additional molecular diagnostic
tests and companion diagnostic services in a timely manner, or at
all; the risk that we may not successfully develop new markets for
our molecular diagnostic tests and companion diagnostic 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 companion diagnostic 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; risks related to increased
competition and the development of new competing tests 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; risks related
to changes in intellectual property laws covering our molecular
diagnostic tests and companion diagnostic 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 most recent Annual
Report on Form 10-K 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.
CONTACT: Media Contact:
Ron Rogers
(801) 584-3065
(908) 285-0248
rrogers@myriad.com
Investor Contact:
Scott Gleason
(801) 584-1143
sgleason@myriad.com
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