Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular
diagnostics and personalized medicine, today announced that new
clinical outcomes and clinical utility data for myPath® Melanoma
will be featured at the American Society of Dermatopathology (ASDP)
52nd meeting being held Oct. 8 to 11, 2015 in San Francisco, Calif.
The findings add to the growing body of knowledge for myPath
Melanoma and will support the Company's clinical reimbursement
dossier for the product.
"The accurate diagnosis of melanoma can be challenging based on
histologic findings alone and there are potentially severe
consequences of a misdiagnosis, including the under-treatment or
overtreatment of patients," said Loren Clarke, M.D., vice
president, Medical Affairs for Dermatology, Myriad Genetic
Laboratories. "Our studies show that myPath Melanoma accurately
differentiates malignant melanoma from benign skin lesions and
helps physicians deliver a more objective and confident diagnosis
for their patients."
A list of the myPath Melanoma presentations at ASDP (#ASDP2015)
follows.
Podium Presentation
Title: Correlation of myPath Melanoma gene expression
score with clinical outcome on a series of melanocytic
lesions.
Date: Saturday, Oct. 10, 2015: 3:00 p.m.
PT.
Location: Hilton Union Square, Continental
4-6.
Eugen Minca, M.D., department of Pathology, Cleveland Clinic,
will present a study that correlates myPath Melanoma test results
with clinical outcomes data (e.g., recurrence, sentinel lymph node
metastases and distant metastases) from 127 patients with
melanocytic lesions. Of these cases, 65 lesions were melanomas and
62 were benign lesions, according to the pathology
diagnosis. The myPath Melanoma test scores were reviewed in
conjunction with the diagnosis and clinical outcome. Of the 65
melanomas, 14 developed metastases and 51 had no adverse events
after 47 months of follow up and myPath Melanoma diagnosed
malignancy in all 14 cases with adverse outcomes, which represents
a 100 percent sensitivity rate in these metastatic cases. There
were no adverse events associated with the 62 benign lesions after
an average follow up of 30 months. Of these, the myPath
Melanoma test produced a benign score in 48 cases, an indeterminate
score in seven cases and a malignant score in seven
cases. Importantly, after myPath testing and upon expert
histologic review, three of the seven cases with a malignant score
were reclassified as melanomas. This is the first study with
clinical outcome data and supports previous validation studies
demonstrating that the myPath Melanoma test provides additional
insight into difficult-to-diagnose lesions, supporting its use as
an ancillary diagnostic test.
Poster Presentation
Title: A retrospective study of the influence of a gene
expression signature on the treatment of melanocytic
tumors.
Date: Thursday, Oct. 8 from 1:00 p.m. PT to Oct. 11 at
11:00 a.m. PT.
Location: Golden Gate, Ballroom.
In this study, 632 difficult-to-diagnose melanocytic lesions
were analyzed using the myPath Melanoma diagnostic
test. Retrospective chart reviews were conducted for 315 of
the cases to document the actual treatment carried out for each
patient. Of these, 214 patients received a benign myPath
Melanoma test result, 92 received a malignant result and nine
received an indeterminate result. The percentage change was
measured from the treatment recommendations of the expert
dermatopathologists to the actual treatment provided by
dermatologists. The results show that excisions were reduced
by 33.1 percent in patients who received a benign myPath Melanoma
test result. Conversely, the use of additional treatment, such
as surgery, increased by 36.2 percent in patients who received a
malignant myPath Melanoma test result. These data support the
integration of the myPath Melanoma test into medical practice to
improve patient care by allowing more definitive diagnoses by
dermatopathologists and optimized treatment decisions by
dermatologists.
About myPath®
Melanoma
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 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: www.mypath.myriad.com
and www.mypathmelanoma.com.
About Myriad Genetics
Myriad 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, myRisk Hereditary Cancer, myChoice, myPlan,
BRACAnalysis CDx, Tumor BRACAnalysis CDx, myChoice HRD, Vectra 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 Statement
This press release contains "forward-looking statements" within
the meaning of the Private Securities Litigation Reform Act of
1995, including statements related to data being presented at the
American Society of Dermatopathology (ASDP) 52nd meeting being held
Oct. 8 to 11, 2015 in San Francisco, Calif.; the ability of myPath
Melanoma to differentiate malignant melanoma from benign skin
lesions and help physicians deliver a more objective and confident
diagnosis for their patients; the ability of the myPath Melanoma
test to demonstrate 100 percent sensitivity and concordance with
the clinical outcome in metastatic melanomas and provide insight to
difficult-to-diagnose lesions; the integration of the myPath
Melanoma test into medical practice to improve patient care by
allowing more definitive diagnoses by dermatopathologists and
optimized treatment decisions by dermatologists; 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; 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, 2015, 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.
CONTACT: Media Contact:
Ron Rogers
(908) 285-0248
rrogers@myriad.com
Investor Contact:
Scott Gleason
(801) 584-1143
sgleason@myriad.com
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