Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular
diagnostics and personalized medicine, today announced that two
important studies will be featured in podium presentations at the
36th annual conference of the National Society of Genetic
Counselors (NSGC) in Columbus, OH.
“We look forward to presenting our pioneering research at NSGC
this year and bringing forward new innovations that are changing
how a woman’s risk of breast cancer is being managed and improving
the lives of even more people,” said Johnathan Lancaster, M.D.,
Ph.D., chief medical officer, Myriad Genetics. “We are particularly
excited to present the results of a large study of our new
hereditary cancer test, called riskScore, that we believe will help
genetic counselors and doctors improve care for their unaffected
patients who test negative for a hereditary mutation. We’re also
looking forward to presenting data from a study that evaluated
variant reclassification in 1.4 million patients tested for
hereditary cancer risk assessment over a 10 year period.”
More information about the company’s presentations can be found
at: www.nsgc.org/conference. Follow Myriad on Twitter via
@MyriadGenetics and stay informed about conference news and updates
by using the hashtag #NSGC17.
myRisk® Hereditary Cancer with riskScore™ Podium
PresentationTitle: Development and
Validation of a Residual Risk Score to Predict Breast Cancer Risk
in Unaffected Women Negative for Mutations on a Multi-Gene
Hereditary Cancer Panel.Presenter: Elisha
Hughes, Ph.D.Date: Saturday, Sept. 16, 2017,
11:30–11:45 a.m.Location: Platform
Presentation, #1131
This study evaluated 86 single nucleotide polymorphisms (SNPs)
as breast cancer risk factors through the validation of a polygenic
residual risk score in large, consecutive cohorts of more than
17,205 women of European ancestry who tested negative for mutations
in known breast cancer susceptibility genes. The results show that
the 86 SNP residual risk score was highly predictive of breast
cancer risk in unaffected women of European ancestry with a family
cancer history who tested negative for germline mutations in known
breast cancer risk genes (p<10-50). The clinical implementation
of a residual risk score for women at risk for hereditary breast
cancer may offer significant potential for the management of
high-risk, unaffected women who test negative for monogenic
mutations in breast cancer-risk genes.
“As healthcare providers our goal is to help patients understand
their risk of breast cancer so that they personalize their medical
care and live healthier lives. Women who have not yet developed
cancer but have a family history of breast cancer should consider
hereditary cancer testing with multi-gene panels,” said Ora Gordon,
M.D., medical director at the Center for Clinical Genetics &
Genomics, Providence Health & Services Southern California.
“Despite being at high familial risk for breast cancer, in reality,
most patients will not carry a hereditary mutation in a breast
cancer-risk gene, which doesn’t mean they’re risk free. For
patients who test negative, there are other factors including SNPs,
family history of cancer and personal factors that may increase the
risk of breast cancer. The new riskScore test combines this data to
provide patients with additional information about their individual
risk for developing breast cancer in five years and over their
lifetime to confirm whether high risk interventions are still
needed despite negative single gene testing results. It can also
provide reassurance that routine surveillance is appropriate
despite having a family history. This is a much needed and long
awaited advance in the personalization of breast cancer risk.”
myRisk® Hereditary Cancer Podium
PresentationTitle: Variant
Reclassification in a Clinical Cohort: A Decade of
Experience.Presenter: Nichole Brown, MS,
CGC.Date: Friday, Sept. 15, 2017, 3:15–3:30
p.m.Location: Platform Presentation,
#1394
This study assessed variant reclassification in 1.4 million
patients tested for hereditary cancer risk assessment between 2006
and 2016. Of these, 96 percent were female, 52 percent were of
European decent and the median age was 49 years. Approximately 56
percent had a personal history of cancer at the time of testing.
Approximately 36,264 unique variants (mutations) were identified
during testing and 293,496 total variants were reported. The
results show that when a comprehensive classification approach is
employed, variant re-classification is relatively common (~19
percent) in genetic testing for hereditary cancer risk.
“Accurate classification of genetic variants can significantly
impact on clinical care of patients and highlights the need timely
reclassification and notification. Our ultimate goal is to
definitively classify all genetic mutations, which is why Myriad
invests so heavily in variant classification research and through
scientific collaborations and publications,” said Lancaster.
“Importantly, Myriad’s commitment to patients
doesn’t stop once we’ve given them a test result.
We understand that science evolves and that’s why we
have a commitment to notify doctors when we learn new information
that could affect patient care. We offer support to patients and
their families that lasts a lifetime.”
About riskScore
riskScore 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 myRisk® Hereditary
Cancer
The Myriad myRisk Hereditary Cancer test uses an extensive
number of sophisticated technologies and proprietary algorithms to
evaluate 28 clinically significant genes associated with eight
hereditary cancer sites including: breast, colon, ovarian,
endometrial, pancreatic, prostate and gastric cancers and
melanoma.
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 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 Statement
This press release contains “forward-looking statements” within
the meaning of the Private Securities Litigation Reform Act of
1995, including statements relating to two important studies being
featured in podium presentations at the 36th annual conference of
the NSGC in Columbus, OH; new innovations changing how a woman’s
risk of breast cancer is managed and improving the lives of people;
riskScore helping genetic counsellors and doctors improve care for
their unaffected patients who test negative for a hereditary
mutation; the clinical implementation of a residual risk score for
women at risk for hereditary breast cancer offering significant
potential for the management of high-risk, unaffected women who
test negative for monogenic mutations in breast cancer-risk genes;
the Company’s commitment to notify doctors when we learn new
information that could affect patient care; offering support to
patients and their families that lasts a lifetime; 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(908) 285-0248rrogers@myriad.com
Investor Contact:Scott Gleason(801)
584-1143sgleason@myriad.com
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