Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular
diagnostics and personalized medicine, today announced results from
a ground-breaking validation study to better define the risk of
breast cancer in women of European ancestry who test negative for a
hereditary cancer mutation with the myRisk® Hereditary Cancer
test. The results are being featured in a Spotlight
presentation today at the 2017 San Antonio Breast Cancer Symposium
(SABCS) in San Antonio, Texas.
“Myriad Genetics is the first to bring to market a comprehensive
approach to lifetime breast cancer risk assessment that includes 28
genes, family history evaluation, and well-validated SNPs through
riskScore,” said Johnathan Lancaster, M.D., Ph.D., chief medical
officer, Myriad Genetics. “This comprehensive approach
delivers the most precise tool in the industry to help physicians
assess a patient’s breast cancer risk and empower choices that may
prevent a patient’s breast cancer from ever happening.”
A summary of this study appears below and more information about
the company’s presentation can be found at:
https://www.sabcs.org/2017-SABCS. Follow Myriad on Twitter
via @MyriadGenetics and stay informed about symposium news and
updates by using the hashtag #SABCS17.
myRisk® Hereditary Cancer with riskScore™ Spotlight
Presentation Title: Development and
Validation of a Combined 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: Wednesday, Dec. 6, 2017,
5:00–7:00 p.m. Location: Poster Discussion,
PD1-08
This study was designed to validate the new
riskScore™ test’s ability to predict the 5-year
and lifetime risk of breast cancer compared to the Tyrer-Cuzick
model alone. riskScore is a novel test that combines data
from the Tyrer-Cuzick model with 86 genetic markers, called single
nucleotide polymorphisms (SNPs), to comprise a combined risk score
that accounts for clinical, familial and genetic variables.
The validation study included 1,617 women: 990 women with breast
cancer and 627 controls. The results show that riskScore is a
highly statistically significant predictor of the 5-year and
lifetime risk of breast cancer (p=5.2x10-39 and p=4.1x10-35,
respectively). Moreover, riskScore was statistically
significantly superior to Tyrer-Cuzick alone for both 5-year and
lifetime risk of breast cancer (1.0x10-12 and 8.3x10-13,
respectively), underscoring the important contribution of the SNPs
to the test.
“The combination of the SNP panel with Tyrer-Cuzick provides
even greater precision than previously demonstrated from family
history models,” said Jerry Lanchbury, Ph.D., chief scientific
officer, Myriad Genetics. “As a result, we believe our myRisk
Hereditary Cancer test, now enhanced with riskScore, provides the
most comprehensive breast cancer risk assessment available
today.”
In a separate analysis, the riskScore test was applied to a
real-world cohort of 6,479 women who tested negative for mutations
in 11 genes associated with hereditary breast cancer to determine
their remaining lifetime risk of developing breast cancer.
The results show that riskScore remaining lifetime risk estimates
ranged from 0.88 percent to 66.4 percent (Graph 1).
Additionally, 38.2 percent of patients tested with riskScore had a
lifetime risk >20 percent and 7.4 percent had a lifetime risk
>3 times the general population (35 percent).
“These data confirm the important contribution of SNPs to breast
cancer risk assessment in unaffected women who test negative for
mutations in hereditary breast cancer genes with a precise measure
of breast cancer risk,” said Lanchbury. “The addition of the
SNP data appears to be especially helpful in identifying those
patients at higher risk for developing breast cancer.”
Graph
1: http://www.globenewswire.com/NewsRoom/AttachmentNg/77414286-874b-4f88-bdae-30a43222b6db
“Patients who are above 20 percent lifetime risk are candidates
for additional screening based on U.S. Preventive Services Task
Force recommendations and those above 35 percent may be candidates
for more aggressive medical interventions,” said Lancaster.
“Importantly, these data show that riskScore identifies a larger
number of high-risk patients than either BRCA1 or BRCA2 testing and
represents the next major epoch in hereditary cancer risk
assessment and patient care.”
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 in women of
European descent. 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.
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 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 presentation of the Company’s riskScore
validation study at the 2017 San Antonio Breast Cancer Symposium;
the ability of riskScore to predict 5-year and lifetime risk of
breast cancer in women who test negative for hereditary breast
cancer mutations; the Company’s belief that its myRisk hereditary
cancer test, now enhanced with riskScore, provides the most
comprehensive breast cancer risk assessment available today; the
utility of the additional SNP data in identifying those patients at
higher risk for developing breast cancer; the number of patients
who are candidates for additional screening based on U.S.
Preventive Services Task Force recommendations and the number of
patients who may be candidates for more aggressive medical
interventions; riskScore identifying a larger number of high-risk
patients than either BRCA1 or BRCA2 testing; the Company’s belief
that riskScore represents the next major epoch in hereditary cancer
risk assessment and patient care; 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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