Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular
diagnostics and personalized medicine, today announced new data
demonstrating the utility of the Prolaris® test to accurately
predict the 10-year risk of metastases in men treated for prostate
cancer. The data are being presented tomorrow at the American
Urological Association (AUA) 2017 Annual Meeting in Boston, Mass.
This study was conducted in collaboration with Stephen Bardot,
M.D., and colleagues at Ochsner Clinic in New Orleans, Louisiana.
A total of 767 men with localized prostate cancer were
evaluated using the Prolaris test plus CAPRA (i.e., clinical
features) to predict the risk of metastatic disease up to 10 years
following diagnosis. Approximately 40 percent of the patients
in the study were African Americans (AA). Among all 767
patients 39 men, or 5.1 percent, developed metastases and among the
646 men who received definitive therapy (e.g., surgery, radiation,
radiation and hormones) 28 men, or 4.3 percent, developed
metastatic disease.
The results showed that the Prolaris test was a significant
predictor of metastatic disease with a nearly 3-fold increased risk
for each one-unit increase on the Prolaris test score (Hazard Ratio
per unit score = 2.76; P = 2.8x10-11). Importantly, there was
no difference in predictive performance between races (p=0.20) or
treatment groups (p=0.09). When combined with CAPRA the
Prolaris test was highly predictive of metastatic disease (HR for
combined clinical risk (CCR) = 3.86; p= 2.8x10-23). Contrary
to expectations, this large study found no evidence that AA men
have more aggressive prostate cancer than non-AA men after
accounting for all molecular and clinical information.
“Our study confirmed that the Prolaris test significantly
predicts which men are likely to develop metastatic disease,
regardless of race, risk group or treatment approach,” said Dr.
Bardot. “This study also included a large group of AA men
which have historically been underrepresented in clinical outcomes
studies. This study demonstrated that Prolaris provided more
accurate precision in providing prognosis in African American and
non-African Americans equally.”
The findings from the current study are consistent with the
findings of an earlier study that demonstrated the ability of the
Prolaris test in predicting cancer progression, as measured by both
biochemical recurrence and metastatic disease, after radical
prostatectomy. That prior study found that patients with a
high Prolaris test score had a six-fold higher risk of developing
metastases compared to low risk patients.
Based on the strength of the data from these two outcomes
studies, Myriad has added risk of metastases to the Prolaris test
report for clinicians, making Prolaris the first and only genetic
test to provide this endpoint as validated by two outcomes
studies.
“Myriad Genetics is committed to innovation and being the leader
in genetic testing for men diagnosed with prostate cancer,” said
Michael Brawer, M.D., senior vice president of Medical Affairs,
Myriad Genetic Laboratories. “We have multiple outcome
studies that show the ability of Prolaris to predict the 10-year
risk of prostate cancer specific mortality, and we now have two
studies that predict the risk that treatment will fail and men will
end up with metastatic disease. We are excited to provide all
of this relevant information in a single test report for
clinicians.”
Follow Myriad on Twitter via @MyriadGenetics and stay informed
about symposium news and updates by using the hashtag #AUA17.
Details of the presentation at AUA follow.
Featured PresentationTitle:
Evaluating the Prognostic Utility of the CCP Score for Predicting
Prostate Cancer Aggressiveness in African American
MenPresenter: Steven Bardot, M.D., Ochsner Medical
CenterDate: Saturday, May 13, 2017: 7:00-9:00 a.m.
ET.Location: Moderated Poster MP28-19; Room
253AB.
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 patients with prostate cancer. 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 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
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, Myriad myRisk, myRisk Hereditary Cancer,
myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx,
myChoice HRD, EndoPredict, Vectra, GeneSight 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 relating to Prolaris data being presented at
the at the American Urological Association’s 2017 Annual Meeting
being held May 12-16, 2017 in Boston, Mass.; the utility of the
Prolaris® test to accurately predict the 10-year risk of metastases
in men treated for prostate cancer; the ability of the Prolaris
test to significantly predict which men are likely to develop
metastatic disease, regardless of race, risk group or treatment
approach; 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
described or implied in the forward-looking statements. These risks
include, but are not limited to: the risk that sales and profit
margins of our existing molecular diagnostic tests and
pharmaceutical and clinical services may decline or will not
continue to increase at historical rates; risks related to our
ability to transition from our existing product portfolio to our
new tests; risks related to changes in the 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 tests and any future tests are terminated or cannot be
maintained on satisfactory terms; risks related to delays or other
problems with operating our laboratory testing facilities; risks
related to public concern over our 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, including
but not limited to our acquisition of Assurex, Sividon and the
Clinic; risks related to our projections about the potential market
opportunity for our products; 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; 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 Annual report on Form 10-K for the fiscal year ended
June 30, 2016, 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.
Media Contact: Ron Rogers
(801) 584-3065
rrogers@myriad.com
Investor Contact: Scott Gleason
(801) 584-1143
sgleason@myriad.com
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