Myriad Advances Prostate and Renal Cancer Molecular Diagnostic Tests at the 2016 ASCO Genitourinary Cancers Symposium
January 07 2016 - 7:05AM
Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular
diagnostics and personalized medicine, today announced that new
data will be highlighted on prostate and renal cancers at the 2016
ASCO Genitourinary Cancers Symposium, January 7-9, in San
Francisco, Calif. These presentations reaffirm the Company’s
commitment to developing pioneering molecular diagnostics in the
fight against urological cancers.
"We are committed to continuing our pioneering work in urology,"
said Dr. Michael Brawer, M.D., senior vice president of Medical
Affairs, Myriad Genetic Laboratories. "Urologic cancers claim
thousands of lives every year and are a leading cause of
disability. Myriad developed Prolaris, the first prostate
cancer prognostic test, and is bringing that same level of rigorous
scientific innovation to renal cancer prognosis as well. We
remain dedicated to developing new biomarker-based diagnostics to
combat urologic diseases and improve patient care."
The following key studies will be presented by collaborators
during the ASCO GU symposium.
Highlighted Presentations
- Title: Application of Active Surveillance
Threshold to Series of Samples Submitted for Commercial
Testing.Date: Thursday, January 7, 2016: 11:30
a.m.–1:00 p.m. PT.Location: Poster Session
A.Presenter: Daniel Lin, M.D., University of
Washington.In this study 11,665 men diagnosed with prostate cancer
were evaluated to determine which patients would be candidates for
active surveillance (AS) based on their combined clinical risk
(CCR) score. CCR is a composite of the Prolaris® test with
clinical features measured by CAPRA (Cancer of the Prostate Risk
Assessment). The results showed that 7,325 men (63 percent)
qualified for AS based on their CCR score. Of these, a
substantial number of patients, 3,306 (45 percent), would not have
qualified for AS based on their clinical features alone.
Therefore, for patients considering deferred treatment, the
Prolaris test provides significant prognostic information at the
time of diagnosis beyond traditional pathological measures of
risk.
- Title: Prognostic Utility of a Multi-Gene
Signature (the Cell Cycle Proliferation Score) in Patients with
Renal Cell Carcinoma after Radical
Nephrectomy.Date: Saturday, January 9, 2016: 11:30
a.m.–1:00 p.m. PT.Location: Poster Session
C.Presenter: Todd Morgan, M.D., University of
Michigan.This study assessed the ability of the myPlan® Renal
Cancer test to predict disease recurrence or disease-specific
mortality in 305 patients who had a radical nephrectomy. The
results demonstrate that myPlan Renal Cancer is a significant
predictor of key long-term oncologic outcomes in patients who have
undergone a radical nephrectomy for renal cancer, providing
information beyond what is available from clinical parameters
alone. When the myPlan score is combined with pathological
stage to provide a composite prognostic score (PS), patients with a
high PS had a three-fold increased risk of recurrence compared to
patients with a low score. These finding suggest that the myPlan
Renal Cancer score may be useful in the clinical management of
patients with renal cancer.
For more information about these presentations, please visit the
ASCO GU website at http://gucasym.org/. Follow Myriad on
Twitter via @MyriadGenetics and stay informed about news and
updates by using the hashtag #GU16.
About Prolaris®
Prolaris is a novel 46-gene RNA-expression test that directly
measures tumor cell growth characteristics for stratifying the risk
of disease-specific mortality in prostate cancer patients. Prolaris
provides a quantitative measure of the RNA expression levels of
genes involved in the progression of tumor growth. Low gene
expression is associated with a low risk of disease-specific
mortality in men who may be candidates for active surveillance and
high gene expression is associated with a higher risk of
disease-specific mortality in patients who may benefit from
additional therapy. For more information visit:
www.prolaris.com.
About Myriad myPlan® Renal Cancer
Myriad myPlan Renal 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 renal cell carcinoma. For more information visit:
https://www.myriad.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 the Company’s commitment to
developing pioneering molecular diagnostics in the fight against
urological disease; data on renal and prostate cancer being
presented at this year’s 2016 ASCO Genitourinary Cancers Symposium;
the ability of Prolaris to provide significant prognostic
information at the time of disease diagnosis; the utility of the
myPlan Renal Cancer test in the clinical management of patients
with renal cancer; 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
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