Myriad Presents Second Pivotal Validation Study for Its myPath® Melanoma Test
March 15 2016 - 7:05AM
Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular
diagnostics and personalized medicine, today announced the results
from the second pivotal clinical validation study for the myPath®
Melanoma test at the 2016 USCAP Annual Meeting in Seattle, Wash.
“There is significant emotional distress associated with a
melanoma diagnosis and doctors want to provide their patients with
accurate information,” said Loren Clarke, M.D., medical director,
Myriad Genetic Laboratories. “We’re developing the myPath Melanoma
test to help pathologists improve the diagnosis of melanoma,
particularly for patients with difficult-to-diagnose skin
lesions.”
In the study with 736 patients, the myPath Melanoma test
effectively diagnosed suspicious lesions with greater than 90
percent diagnostic accuracy, 91.5 percent sensitivity and 92.5
percent specificity. This second validation is consistent
with the first validation study with 437 patients that demonstrated
a diagnostic accuracy of greater than 90 percent.
“myPath Melanoma is an extremely robust diagnostic test with
unmatched clinical validity data, having completed the largest
clinical validation study for a melanoma diagnostic test,” said
Clarke. “We have now demonstrated in two pivotal validation
studies that myPath Melanoma accurately differentiates patients
with melanoma from those with benign moles.”
The Company also announced that it will present new data on its
myPlan® Lung Cancer prognostic test at USCAP. Details about
the featured Myriad presentations at USCAP are below. Follow
Myriad on Twitter via @MyriadGenetics and stay up-to-date by using
the hashtag #USCAP16.
myPath Melanoma Poster Presentation
- Title: An independent validation of a gene
expression signature to differentiate malignant melanoma from
benign melanocytic nevi.Date: Tuesday, March 15,
2016: 1:00 to 4:30 p.m. PT.Location: Poster
84.Presenter: Hillary Kimbrell, M.D., Myriad
Genetic Laboratories.
In this clinical validation study, 736 melanocytic lesions,
diagnosed as either benign or malignant by a panel of three expert
dermatopathologists, were evaluated using the myPath Melanoma gene
expression test. The results showed that the myPath Melanoma
test differentiated malignant melanoma from benign nevi with a
sensitivity of 91.5 percent and specificity of 92.5 percent.
These findings were consistent across melanoma subtypes.
There were several instances where the myPath test score differed
from the pre-test diagnosis, causing the dermatopathologists to
revise their initial diagnosis. These findings demonstrate
the ability of the myPath Melanoma test to help diagnose cases of
melanoma in samples representative of those seen in routine
clinical practice.
myPlan Lung Cancer Poster Presentation
- Title: Cell cycle progression score is a
promising predictor of recurrence in primary lung carcinoid
tumors.Date: Monday, March 14: 1:00 to 4:30 p.m.
PT.Location: Poster
1874. Presenter: Neda Kalhor, M.D., MD
Anderson Cancer Center.
This exploratory study evaluated the cell cycle progression
(CCP) score in pulmonary carcinoid tumors resected at the MD
Anderson Cancer Center. The study cohort included 93 patients,
including 79 with typical carcinoids (TC) and 14 with atypical
carcinoids (AC). The results showed a significant association
between the CCP score and recurrence free survival (RFS) in this
cohort. These early findings suggest the CCP score may help
in effective stratification of primary lung carcinoids to identify
high-risk tumors that may require adjuvant therapy.
About myPath®
MelanomamyPath 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.
https://www.myriad.com/products-services/melanoma/mypath-melanoma/.
About Myriad myPlan® Lung CancerMyriad myPlan
Lung Cancer is a molecular prognostic test that measures the
expression levels of cell cycle progression genes to provide an
accurate assessment of cancer aggressiveness in patients with
early-stage non-small cell lung adenocarcinoma. For more
information visit:
https://www.myriad.com/products-services/lung-cancer/myplan-lung-cancer/.
About Myriad GeneticsFor more than 25 years,
Myriad Genetics Inc. has been 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 StatementThis press release contains
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995, including statements
related to the ability of the myPath Melanoma test to help
pathologists improve the diagnosis of melanoma; 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.
Media Contact:
Ron Rogers
(908) 285-0248
rrogers@myriad.com
Investor Contact:
Scott Gleason
(801) 584-1143
sgleason@myriad.com
Myriad Genetics (NASDAQ:MYGN)
Historical Stock Chart
From Aug 2024 to Sep 2024
Myriad Genetics (NASDAQ:MYGN)
Historical Stock Chart
From Sep 2023 to Sep 2024