Prolaris® Test Accurately Predicts Risk of Metastasis in Men Diagnosed with Localized Prostate Cancer
June 27 2019 - 07:28AM
Myriad Genetics, Inc. (NASDAQ: MYGN), a global leader in
personalized medicine, today announced publication of results from
a large study that demonstrated the Prolaris test can accurately
predict the 10-year risk of metastases in men newly diagnosed with
localized prostate cancer. The study was published in journal
Prostate Cancer and Prostatic Diseases.
“This study demonstrates that the Prolaris test
effectively identified those men with localized prostate cancer who
progressed to metastatic disease,” said Stephen Bardot, M.D., a
study investigator and chairman, Department of Urology Associate
Medical Director, Surgical Services at the Oschner Clinic.
“Importantly, the Prolaris test provided critical information that
can be used to determine which men with localized prostate cancer
are candidates for active surveillance and which men should receive
definitive therapy with surgery or radiation at the time of
diagnosis.”
The large pooled analysis included 1,062 men with
localized prostate cancer who were definitively treated with
surgery (n=800) or radiation (n=262). The primary objective
was to evaluate ability of the Prolaris test (CCP score) and the
Prolaris test combined with clinical information (CCR) to predict
10-year risk of progression to metastatic disease. The
analysis demonstrated the Prolaris test was the strongest
independent predictor of progression to metastatic disease, and men
were approximately three times more likely to develop metastatic
disease with each unit increase in the Prolaris test score (HR:
2.93; p=1.8x10-11). When the Prolaris test score was combined
with clinical information the results were even more highly
prognostic, and men were up to four times more likely to develop
metastases with each unit increase in the test score (Figure 1: HR:
4.00; p=6.3x10-21).
Figure 1. Prolaris Test
Accurately Predicts Risk of Prostate Cancer
Progressionhttps://www.globenewswire.com/NewsRoom/AttachmentNg/75f9dcd1-6bde-474e-a999-88443eff0cfc
“We are excited by these positive study results
that advance our understanding of prostate cancer and build on
multiple prior studies demonstrating the clinical performance of
the Prolaris test,” said Todd Cohen, M.D., board certified
urologist and vice president of Medical Affairs, Myriad
Urology. “Importantly, these data showed that men with
localized prostate cancer and a high Prolaris score were up to four
times more likely to develop metastatic disease. This information
can help guide treatment planning decisions so that men receive the
best care and health outcomes.”
About Prostate CancerAccording the
American Cancer Society, more than 165,000 men will be diagnosed
with prostate cancer this year. The National Comprehensive
Cancer Network (NCCN) medical guidelines for prostate cancer
treatment include biomarker testing as an element of clinical care
and support Prolaris as standard-of-care to help inform treatment
decisions for patients with low and favorable-intermediate risk
prostate cancer.
About Prolaris®Prolaris is a
genetic test developed by Myriad that directly measures tumor cell
growth. The Prolaris test paired with both prostate-specific
antigen (PSA) and Gleason provides the level of aggressiveness of a
patient’s individual prostate cancer. PSA and Gleason only
have the ability to identify how far the cancer has progressed thus
far. However, when these are combined with a Prolaris test
score, patients get an accurate assessment of how aggressively that
cancer will progress over the next ten years. For more information
visit: www.prolaris.com.
About Myriad GeneticsMyriad
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 five strategic imperatives:
build upon a solid hereditary cancer foundation, growing new
product volume, expanding reimbursement coverage for new products,
increasing RNA kit revenue internationally and improving
profitability with Elevate 2020. 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, Myriad myRisk, myRisk
Hereditary Cancer, myChoice, myPlan, BRACAnalysis CDx, Tumor
BRACAnalysis CDx, myChoice HRD, EndoPredict, Vectra, GeneSight,
riskScore, Prolaris, Foresight and Prequel 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 relating to the Prolaris test providing critical
information that can be used to determine which men with localized
prostate cancer are candidates for active surveillance and which
men should receive definitive therapy with surgery or radiation at
the time of diagnosis; the Prolaris test providing information that
can help guide treatment planning decisions so that men receive the
best care and health outcomes; 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; the risk that we may be unable to comply with
financial operating covenants under our credit or lending
agreements; the risk that we will be unable to pay, when due,
amounts due under our credit or lending agreements; 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, 2018, 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
Investor Contact: Scott
Gleason
(801) 584-3065
(801)
584-1143
rrogers@myriad.com
sgleason@myriad.com
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