Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular
diagnostics and personalized medicine, announced today that results
from a large 1,162 patient study of the Myriad myRisk® Hereditary
Cancer test will be featured during the poster presentation at the
2018 Genitourinary Cancer Symposium in San Francisco, Calif.
The key finding is that more than 12 percent of men with prostate
cancer had an inherited (i.e. hereditary) mutation in a
cancer-causing gene.
“As one of the largest studies of hereditary cancer risk
assessment ever conducted in prostate cancer, our myRisk Hereditary
Cancer test demonstrated that roughly the same percentage of men
with prostate cancer carry hereditary cancer-causing mutations as
do women with breast cancer,” said Johnathan Lancaster, M.D.,
Ph.D., chief medical officer, Myriad Genetics. “These
compelling findings provide a strong reason for expanding the use
of genetic testing in men diagnosed with prostate cancer consistent
with existing professional medical guidelines.”
The key data are summarized below and the abstract is available
at: abstracts.asco.org. Follow Myriad on Twitter via
@MyriadGenetics and stay informed about symposium news and updates
by using the hashtag #GU18.
Title: Inherited Germline Mutations in
Men with Prostate Cancer.Presenter: Robert
Reid, M.D., Virginia Cancer
Specialists.Date: Sunday, February 9, 2018,
12:15 – 1:45 p.m. and 6:00 p.m. – 7:00 p.m.
Location: Poster
Board E4; Poster Abstract 357.
The study will be presented by Robert Reid, M.D. from the
Virginia Cancer Specialists who served as the lead investigator of
this study. The study objective was to evaluate genetic
testing using the 28-gene myRisk Hereditary Cancer test in 1,162
men with a personal history of prostate cancer. Of these, 64
percent had a history of prostate cancer, while 36 percent had a
history of prostate cancer and at least one additional
cancer. The results showed that 12.1 percent of men with
prostate cancer were positive for one or more hereditary cancer
mutations in the genes tested. Additionally, the positive
rate was significantly higher among men with prostate cancer plus
one other cancer (14.7 percent). The inherited mutations were
found in genes with a well-known prostate cancer risk (i.e., BRCA2)
as well as genes historically associated with other cancer types
including breast and colon. These findings suggest that
hereditary cancer testing in men with prostate cancer may aid in
medical management decision making to reduce overall cancer
risk.
“We believe hereditary cancer testing can help inform treatment
decisions for these men, including whether to pursue active
surveillance, increased screening for secondary cancers and
potentially for treatment selection with PARP inhibitors or other
medicines in the future,” said Dr. Lancaster. “Additionally,
once men know they carry an inherited mutation, they can encourage
their family members to get tested to learn if they’re at increased
risk for cancer and potentially help them prevent future
cancers.”
The National Comprehensive Cancer Network, American Urological
Association (AUA) and an academic consensus panel all support
hereditary cancer risk assessment for patients with prostate cancer
deemed to be high risk due to metastatic disease or high grade
cancer with a family history of BRCA associated cancers including
breast, ovarian, pancreatic or prostate cancer.
Importantly, the AUA position states that: “Patients with
localized prostate cancer who are at highest risk for developing
metastatic castration-resistant prostate cancer, may have a higher
incidence of germline DNA repair mutations than expected from
published reports. The presence of germline DNA repair gene
mutations has important implications for the prostate cancer
patient in terms of general cancer screening and possible future
prostate cancer treatment decisions. Additionally the presence of
germline DNA repair mutations is of utmost relevance to the
patient’s first-degree family members due to increased cancer risk
and screening implications.”
About Prostate Cancer One in nine American men
will have prostate cancer during his lifetime. Prostate cancer is
the second leading cause of cancer death among American men and is
the most commonly diagnosed. The American Cancer Society
estimates in its Cancer Facts & Figures 2018 report
that 164,690 men will be told they have prostate cancer in 2018.
Currently, there are nearly 2.9 million American men living
with the disease and every 18 minutes another American man dies
from prostate cancer. That’s a little more than 80 deaths per day
and 29,430 this year.
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. The
myRisk Hereditary Cancer test offers physicians several distinct
advantages over other commercial tests, including unsurpassed lab
accuracy, industry leading variant classification and exceptional
customer service.
Men with prostate cancer can take the Hereditary Cancer Quiz to
find out if they might be at risk for an inherited mutation and
qualify for 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: build upon a solid hereditary
cancer foundation, 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
related to results from a large 1,162 patient study of the Myriad
myRisk® Hereditary Cancer test being featured during the poster
presentation at the 2018 Genitourinary Cancer Symposium in San
Francisco; the study findings providing a strong reason for
expanding the use of genetic testing in men diagnosed with prostate
cancer consistent with existing professional medical guidelines;
the study being presented by Robert Reid, M.D. from the Virginia
Cancer Specialists; hereditary cancer testing in men with prostate
cancer aiding in medical management decision making to reduce
overall cancer risk; hereditary cancer testing helping inform
treatment decisions for these men, including whether to pursue
active surveillance, increased screening for secondary cancers and
potentially for treatment selection with PARP inhibitors or other
medicines in the future; knowledge that they carry an inherited
mutation potentially helping them and their families prevent future
cancers; and the Company's strategic directives under the captions
“About BRACAnalysis CDx,” and "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, 2016, 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(908) 285-0248rrogers@myriad.com |
|
Investor
Contact: |
Scott
Gleason(801) 584-1143sgleason@myriad.com |
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