Myriad Adds to Scientific Evidence for the myPlan(R) Lung Cancer Prognostic Test
September 21 2015 - 8:46PM
Myriad Genetics, Inc. (NASDAQ:MYGN) today presented two posters on
its myPlan® Lung Cancer prognostic test at the International
Association for the Study of Lung Cancer (IASLC) 16TH World
Conference on Lung Cancer being held in Denver, Colo.
The first study showed that the myPlan Lung Cancer test
identified more patients with Stage IB lung cancer who are at risk
for disease progression than were identified with National
Comprehensive Cancer Network (NCCN) high-risk factors alone. The
second study highlighted the successful analytical validation of
the myPlan test, which demonstrated very high analytical
precision.
"We use relatively crude categories of stage that were developed
over 60 years ago to decide when to give chemotherapy. There is no
routine assessment of the biology of the tumor, which we now know
is a primary determinant of the risk of recurrence and cancer
death," said Daniel Oh, M.D., Keck School of Medicine, University
of Southern California. "Several validation studies from
premiere cancer centers in this country have been presented and
published that demonstrate the efficacy of myPlan Lung
Cancer. I believe that the test is an important step forward
in improving outcomes of lung cancer patients and allows a more
rational approach to tailoring the treatment of our patients."
Below are details of the myPlan Lung Cancer studies that were
highlighted at #WCLC2015.
Poster Presentation: P3.04-074. Title:
Prognostic Multigene Molecular Assay Might Improve Identification
of Pathologic Stage IB Lung Adenocarcinoma Patients at Risk for
Recurrence. Date: Wednesday, Sept. 9, 2015: 9:45
to 10:45 a.m. and 3:45 to 4:45 p.m.
This study compared Stage IB patient risk as assessed by the
myPlan Lung Cancer prognostic test score, which is a combination of
cell cycle progression score and pathologic stage, versus NCCN
high-risk features. Of the 279 Stage IB patients evaluated,
183 (65.6 percent) were designated high risk by the myPlan Lung
Cancer test. Of these high-risk patients, less than 50 percent
had three or more high-risk features as defined by NCCN
guidelines. This study demonstrated that the myPlan Lung
Cancer test can identify high-risk patients that would have been
otherwise designated as low risk according to NCCN pathological
features. Importantly, in the Stage IB population, the myPlan
test provided quantitative risk information above that determined
by current NCCN high-risk features. Patients with resected
Stage I lung adenocarcinoma and a high myPlan Lung Cancer score may
be candidates for adjuvant therapy to reduce cancer-related
mortality.
Poster Presentation: P3.04-084. Title:
Analytical Validation of a Proliferation-Based Signature Used as a
Prognostic Marker in Early-Stage Lung Adenocarcinoma.
Date: Wednesday, Sept. 9, 2015: 9:45 to 10:45 a.m. and 3:45
to 4:45 p.m.
This study successfully validated the analytical performance of
the myPlan Lung Cancer test using formalin-fixed paraffin embedded
(FFPE) tissue samples from patients with lung cancer by assessing
precision, dynamic range and RNA input requirements. The results
showed that the test had a standard deviation of 0.06 score units,
which is only one percent of the clinical range of scores, and
demonstrates that the myPlan Lung Cancer test is highly
reproducible. The positive results from this study form an
important component of the analytical validation section in our
reimbursement dossier.
About Myriad myPlan® Lung Cancer
Myriad 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 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 the ability of the myPlan
Lung Cancer test to identify significantly more patients with Stage
IB lung cancer who are at risk for disease progression; the
analytical validation and precision of the myPlan Lung Cancer test;
the belief that the test is an important step forward in improving
outcomes of lung cancer patients and allowing a more rational
approach tailoring the treatment of patients; 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 in 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
Myriad Genetics (NASDAQ:MYGN)
Historical Stock Chart
From Mar 2024 to Apr 2024
Myriad Genetics (NASDAQ:MYGN)
Historical Stock Chart
From Apr 2023 to Apr 2024