Myriad Launches riskScore™ Beginning the Next Epoch in Hereditary Cancer Testing
September 05 2017 - 4:05PM
Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular
diagnostics and personalized medicine, announced today that it has
launched riskScore
™, a new clinically validated
precision medicine tool to enhance its myRisk
®
Hereditary Cancer test. riskScore quantifies a woman’s risk of
developing breast cancer by combining genetic markers throughout
the genome with her family and clinical history.
“We have known for some time that there are other genetic and
clinical factors that can modify a patient’s risk for breast
cancer; however, this is the first time that this information has
been rigorously validated to guide patient care,” said Mark C.
Capone, president and CEO, Myriad Genetics. “As the pioneer in
hereditary cancer research, Myriad has been stalwart in our
commitment to provide answers to every patient concerned about
their breast cancer risks. Through the years Myriad has expanded
the number of genes tested and demonstrated an unmatched commitment
to classifying uncertain variants. Now this new test will provide
definitive answers to the ninety percent of patients testing
negative for hereditary cancer genes and will be complimentary to
patients tested with myRisk®.”
riskScore is a proprietary algorithm that combines data from
greater than 80 genetic markers called single nucleotide
polymorphisms (SNPs), with a best-in-class family and personal
history algorithm called the the Tyrer-Cuzick model. Myriad
researchers optimized the genetic markers in riskScore by starting
with over 100,000 patient samples and have now completed two highly
statistically significant validation studies in patients of
European descent demonstrating the ability of riskScore to predict
breast cancer risk. These major validation studies will be
presented at the National Society of Genetic Counselors Annual
Conference and San Antonio Breast Cancer Symposium later this
calendar year.
“Having been the leader in every major epoch in hereditary
cancer testing, we feel particularly proud of the innovative
research employed to develop the riskScore test,” said Jerry
Lanchbury, Ph.D., chief scientific officer, Myriad Genetics. “The
test will actually provide definitive answers for a higher
percentage of patients than any previous test and is based upon a
rigorous clinical validation. When decisions matter, patients can
rely on the quality of Myriad research.”
Conference Call and WebcastMyriad will host an
investor conference call today, Tuesday, September 5, 2017, at 4:30
p.m. ET to discuss to discuss the launch of riskScore. The
dial-in number for domestic callers is (800) 624-1547.
International callers may dial (303) 223-4380. All callers
will be asked to reference reservation number 21857299. An
archived replay of the call will be available for seven days by
dialing (800) 633-8284 and entering the reservation number
above. The conference call along with a slide presentation
will also will be available through a live webcast at
www.myriad.com.
About riskScoreriskScore is a new clinically
validated personalized medicine tool that enhances Myriad’s
myRisk® Hereditary Cancer test. riskScore helps to
further predict a women’s lifetime risk of developing breast
cancer using clinical risk factors and genetic-markers
throughout the genome. The test incorporates data from greater than
80 single nucleotide polymorphisms identified through 20 years of
genome wide association studies in breast cancer and was validated
in our laboratory to predict breast cancer risk. This data is then
combined with a best-in-class family and personal history
algorithm, the Tyrer-Cuzick model, to provide every patient with
individualized breast cancer risk. riskScore is offered
free-of-charge as an added service to Myriad’s myRisk Hereditary
Cancer test.
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: stabilizing hereditary cancer
revenue, 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 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 StatementThis press release
contains “forward-looking statements” within the meaning of the
Private Securities Litigation Reform Act of 1995, including
statements relating to the launch of riskScore, a new clinically
validated precision medicine tool to enhance the Company’s
myRisk® Hereditary Cancer test; the ability of the
riskScore tool to provide definitive answers to the ninety percent
of patients testing negative for hereditary cancer genes and being
complimentary to patients tested with the myRisk test; the
presentation of major validation studies for the riskScore tool at
the National Society of Genetic Counselors Annual Conference and
San Antonio Breast Cancer Symposium later this calendar year; the
ability of the riskScore tool to actually provide definitive
answers for a higher percentage of patients than any previous test;
patients relying on the quality of Myriad research; the date and
time of the conference call and webcast announcing the riskScore
tool; 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 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 most recent Annual Report on Form 10-K, 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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