Myriad’s Prolaris® Test Significantly Improves the Risk Classification for One Third of Men Diagnosed with Localized Prost...
February 17 2017 - 7:05AM
Myriad Genetics, Inc. (NASDAQ:MYGN), a global leader in
personalized medicine, today announced new data demonstrating the
utility of the Prolaris® test to more accurately classify mortality
risk and guide the management of newly diagnosed men with prostate
cancer. The data are being presented at the 2017
Genitourinary Cancers Symposium (ASCO GU) meeting in
Orlando, Fla.
“Myriad is pioneering personalized medicine for prostate cancer
and is committed to helping men achieve their treatment
goals,” said Michael Brawer, M.D., vice president of
Medical Affairs, Myriad Genetic Laboratories. “We are excited
about the new data on prostate cancer reclassification being
presented at ASCO GU, which adds to the growing body of evidence
supporting the Prolaris test and will help urologists to match
treatment options with patients’ risk profiles.”
Poster PresentationTitle:
Patient NCCN Risk Classification Based on Combined Clinical Cell
Cycle Risk (CCR) Score.Presenter: Steve Stone,
Ph.D.Date: Friday, Feb. 17, 2017: 12:15-1:45 and
6:00-7:00 p.m. ET.Location: C-17.
This study evaluated the prognostic information provided by the
Prolaris test plus CAPRA (i.e., clinical features) to generate an
estimate of prostate cancer mortality within 10 years of diagnosis
versus NCCN risk category as determined by clinical features
alone. The analysis included data from 16,442 men who
received the Prolaris test. Based on clinical features alone,
men were classified according to NCCN guidelines as low (n=8,695),
favorable intermediate (n=3,347), intermediate (n=3,086) or high
risk (n=1,224).
After recalculating the risk of prostate cancer mortality using
the Prolaris test plus CAPRA, approximately one third of patients
were reassigned to a different 10-year mortality risk
category. The specific reclassifications by NCCN category
were as follows:
- Low Risk: 25 percent reclassified to favorable
intermediate or intermediate risk.
- Favorable Intermediate Risk: 24 percent
reclassified to lower and 23 percent to higher risk.
- Intermediate Risk: 24 percent reclassified to
lower and 25 percent to higher risk.
- High Risk: 25 percent reclassified to
favorable intermediate or intermediate risk.
“Clinical features alone are useful, but as this study
illustrates, and was demonstrated by our numerous prior clinical
validation studies, the Prolaris test is a powerful and independent
predictor of clinical outcome that can substantially improve the
risk classification of newly diagnosed men with prostate cancer,”
said Brawer.
Follow Myriad on Twitter via @MyriadGenetics and stay informed
about symposium news and updates by using the hashtag #GU17.
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 data being presented at the at the
2017 Genitourinary Cancers Symposium; the ability of the
Prolaris test to more accurately classify mortality risk and guide
the management of newly diagnosed men with prostate cancer; the
ability to help urologists to match treatment options with
patients’ risk profiles; 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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