Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in molecular
diagnostics and personalized medicine, announced today that results
from two studies of the myRisk® Hereditary Cancer test will be
featured today in presentations at the annual meeting of the
American Society of Clinical Oncology (ASCO).
The key findings were that women with post-menopausal breast
cancer had a high rate of inherited mutations in a range of cancer
causing genes, and that overall this mutation rate did not diminish
with age. In a separate study, panel testing did not appear
to result in over-use of preventative surgery. The findings
will be presented by research collaborators from Stanford
University Cancer Institute and the University of Southern
California (USC) Norris Comprehensive Cancer Center.
“We thank our research partners for their outstanding
collaboration, and are excited to share new information that
advances the field of personalized medicine for people with or at
risk for breast cancer,” said Johnathan Lancaster, M.D.,
Ph.D., chief medical officer, Myriad Genetics, Inc. “As
scientific evidence continues to mount, we have entered an era when
all women diagnosed with breast cancer should be considered for
genetic testing.”
Summaries of the studies appear below and abstracts are
available at https://abstracts.asco.org. Please visit Myriad
Genetics at booth #5087 to learn more about our leading portfolio
of personalized medicine products. Follow Myriad on Twitter
via @myriadgenetics and keep up to date with ASCO meeting news and
updates by using the hashtag #ASCO19.
myRisk Hereditary Cancer Poster Presentations
Title: Prevalence and penetrance of
inherited pathogenic variants in breast cancer susceptibility genes
in the Women’s Health Initiative.Presenter:
Allison Kurian, M.D., Stanford University Cancer
Institute.Date: Monday, June 3, 2019, 1:15 –
4:15 p.m. Location: Poster 1513
This Women’s Health Initiative ancillary study (AS508)
used the myRisk Hereditary Cancer test to evaluate the prevalence
and penetrance of pathogenic variants across 28 genes in 2,195
post-menopausal women with breast cancer compared to 2,322
post-menopausal women without breast cancer. The study
demonstrated that approximately seven percent of patients with
breast cancer tested positive for a pathogenic variant.
Importantly, these mutations were in genes of high penetrance
(BRCA1/2, OR = 5; BARD1, OR=10; PALB2, OR=6; other breast cancer
genes, OR=2), and the mutation rate in non-BRCA1/2 genes did not
diminish with age.
“Approximately 80 percent of breast cancers occur in
postmenopausal women, and this study shows that many of these
women carry harmful mutations in high penetrance breast cancer
genes,” said Dr. Lancaster. “These findings reinforce
the importance of expanded access to broader genetic testing for
women with breast cancer.”
Title: Preventive surgery after multiplex
genetic panel testing. Presenter: Gregory
Idos, M.D., USC Norris Comprehensive Cancer
Center.Date: Monday, June 3, 2019, 1:15 –
4:15 p.m. Location: Poster 1525.
This study evaluated surgery utilization in a prospective,
multi-institutional cohort of 1,537 women who received multiplex
genetic panel testing with the myRisk Hereditary Cancer test.
Overall, 12.9 percent of patients reported surgery after testing.
Preventive surgery utilization was statistically significantly
higher among patients who tested positive for a pathogenic mutation
compared to those testing negative or with a VUS (p<0.001).
Preventive surgery was very low among patients testing
negative or VUS who had no personal history of cancer.
“This study found that patients with a clinically-actionable
genetic mutation and/or personal history of cancer were most likely
to receive surgery, while those with a VUS or negative result and
no cancer history were least likely to undergo surgery,” said Dr.
Lancaster. “Importantly, this study demonstrates that surgery
was not over-utilized following genetic panel testing.”
About Myriad myRisk® Hereditary
CancerThe Myriad myRisk Hereditary Cancer test uses an
extensive number of sophisticated technologies and proprietary
algorithms to evaluate 35 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
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, riskScore Prolaris,
ForeSight and Prequel 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
related to the presentation of data from two clinical studies at
the 2019 American Society of Clinical Oncology annual meeting to be
held May 31 to June 4, 2019 in Chicago, Ill; key podium
presentations highlighting the performance of the myRisk hereditary
multigene panel test in assessing hereditary cancer risk; the
myRisk Hereditary Cancer studies presented at ASCO advancing the
field of hereditary cancer testing; the new data providing
additional evidence for the safety and efficacy of the myRisk
Hereditary Cancer test to help improve and save the lives of
patients; many post-menopausal women carrying harmful mutations in
high penetrance breast cancer genes; entering an era when all women
diagnosed with breast cancer should be considered for genetic
testing; these study findings reinforcing the importance of
expanded access to broader genetic testing for women and breast
cancer; 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 set
forth in or implied by forward-looking statements. These risks and
uncertainties include, but are not limited to: the risk that sales
and profit margins of our molecular diagnostic tests and
pharmaceutical and clinical services may decline; risks related to
our ability to transition from our existing product portfolio to
our new tests, including unexpected costs and delays; risks related
to decisions or changes in 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 and any future tests and services are terminated or cannot
be maintained on satisfactory terms; risks related to delays or
other problems with operating our laboratory testing facilities and
our healthcare clinic; 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; risks related to our projections about our business,
results of operations and financial condition; risks related to the
potential market opportunity for our products and services; 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 or other intellectual property; 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; and other
factors discussed under the heading "Risk Factors" contained in
Item 1A of our most recent Annual Report on Form 10-K for the
fiscal year ended June 30, 2018, 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. All information in
this press release is as of the date of the release, and Myriad
undertakes no duty to update this information unless required by
law.
Media Contact: |
Ron Rogers |
Investor Contact: |
Scott Gleason |
|
(908) 285-0248 |
|
(801) 584-1143 |
|
rrogers@myriad.com |
|
sgleason@myriad.com |
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