Myriad Validates Polygenic Score to Predict Breast Cancer Risk in Women of Hispanic Ancestry Who Test Negative for Hereditary...
December 06 2018 - 8:30AM
Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in molecular
diagnostics and personalized medicine, today announced results from
an important study to validate the polygenic component of a
forthcoming riskScore™ test for Hispanic women who test negative
for a hereditary cancer mutation with the myRisk® Hereditary Cancer
test. The results are being presented at the 2018 San Antonio
Breast Cancer Symposium (SABCS) in San Antonio, Texas.
“A year ago, we launched riskScore as a significant enhancement
to myRisk® to provide women of European ancestry with additional
genetic information about their lifetime risk of developing breast
cancer,” said Jerry Lanchbury, Ph.D., chief scientific officer,
Myriad Genetics. “This year we are excited to presents
results from almost 14,000 women which is the largest polygenic
study ever conducted for Hispanic ancestry. It is another
step in our commitment to make riskScore accessible to all women,
including those most underrepresented in our health care
system.”The key data being presented at SABCS are summarized
below. Please visit Myriad at Booth #1001 to learn more about
genetic testing for breast cancer. Follow Myriad on Twitter
via @myriadgenetics and keep up to date with Symposium news and
updates by using the hashtag #SABCS18.
Polygenic Score Poster Presentation
Title: Development and Validation of a
Polygenic Score to Predict Breast Cancer Risk in Unaffected
Hispanic Women Negative for Mutations on a Multigene Hereditary
Cancer Panel.Presenter: Elisha Hughes,
Ph.D.Date: Friday, Dec. 7, 2018, 5:00 – 6:00
p.m. Poster: P5-10-02
This study evaluated 87 single nucleotide polymorphisms (SNPs)
as breast cancer risk factors through the validation of a polygenic
score in 8,487 women of Hispanic ancestry. The results show
that the 87-SNP polygenic score was highly predictive of breast
cancer risk in unaffected Hispanic women with a significant family
cancer history who tested negative for germline mutations in known
breast cancer risk genes (p=7.1x10-19). Estimates of relative
risk due to SNPs ranged from 0.2 to 3.6 (Graph 1). The clinical
implementation of riskScore for women of Hispanic ancestry may
significantly improve the management of high-risk Hispanic women
who test negative for mutations in with the myRisk Hereditary
Cancer test.
“In this study, we identified a novel SNP-based polygenic score
that provides significant breast cancer predictive value in
individuals of Hispanic ancestry,” said Lanchbury. “Our next
task is to validate the combination of the polygenic score with the
Tyrer-Cuzick model in Hispanic women.”
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 more 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 a value-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
29 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 announced study results validating the
polygenic component of a forthcoming riskScore™ test for Hispanic
women who test negative for a hereditary cancer mutation with the
myRisk® Hereditary Cancer test; the results being presented at the
2018 San Antonio Breast Cancer Symposium (SABCS) in San Antonio,
Texas; the introduction of a riskScore test for Hispanic women who
test negative for a hereditary cancer mutation with the myRisk®
Hereditary Cancer test; the Company’s commitment to make riskScore
accessible to all women, including those most underrepresented in
our health care system; 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, Crescendo, Sividon
and Counsyl; 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 |
Investor Contact: |
Scott Gleason |
|
(908) 285-0248 |
|
(801) 584-1143 |
|
rrogers@myriad.com |
|
sgleason@myriad.com |
A photo accompanying this announcement is available at
http://www.globenewswire.com/NewsRoom/AttachmentNg/baf72eac-90bc-48ee-9e59-4b98dbeafb4c
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