Myriad Applauds the American Society of Breast Surgeons New Guidelines Recommending Genetic Testing for All People with Breas...
February 15 2019 - 7:05AM
Myriad Genetics, Inc. (NASDAQ: MYGN), a global leader in
personalized medicine, today announced its support of the American
Society of Breast Surgeons (ASBrS) new guidelines that
recommend all people diagnosed with breast cancer undergo genetic
testing with a multi-gene panel.
“We applaud the ASBrS for recognizing important advances in
scientific knowledge, and for recommending genetic testing for all
people with breast cancer,” said Johnathan Lancaster, M.D., Ph.D.,
chief medical officer, Myriad Genetics. “The valuable
information provided by genetic testing enhances physicians’
ability to select appropriate precision treatments, personalize
care for patients and their families and improve health
outcomes.”
These new ASBrS guidelines are based on research recently
published by the Targeted Medical Education (TME) Breast Care
Network in the Journal of Clinical Oncology. The study
demonstrated patients who met existing National Comprehensive
Cancer Network (NCCN) clinical testing criteria had similar rates
of pathogenic/likely pathogenic hereditary mutations in breast
cancer genes (9 percent) as patients who did not meet NCCN criteria
(8 percent).
“I am excited by our new ASBrS guidelines and look forward to
the day when NCCN updates its guidelines also. The exciting new
data demonstrated that about half of patients with breast cancer
have clinically-actionable mutations that are being missed when
genetic testing is restricted to patients meeting current NCCN
guidelines.” said Walton Taylor, M.D., President of ASBrS. In
his letter to the membership, he cautioned that “As genetic testing
expands, it is important to choose the lab carefully making sure
they provide quality testing with accurate results and appropriate
follow-up.”
Myriad Genetics has been a leader in hereditary cancer testing
for over two decades and Myriad’s myRisk® Hereditary Cancer
test is the market leading test for patients trying to understand
their hereditary cancer risk. According to the American Cancer
Society, 330,000 people are diagnosed with breast cancer annually
in the United States, and an estimated 10 percent of these are
caused by inherited mutations. Fewer than 10 percent of
BRCA1/2 carriers have been identified, and up to 80 percent of
individuals at risk have not received genetic testing because they
do not meet family history criteria of current testing
guidelines. The National Cancer Institute estimates that
35,000 patients with breast cancer have pathogenic BRCA1/2
mutations, but only 30 percent have been identified. Additionally,
an estimated 10 to 15 percent of women who test negative for
BRCA1/2 mutations have pathogenic variants in other cancer
susceptibility genes including: ATM, CDH1, CHEK2, NBN, NF1, PALB2,
TP53, STK11 and PTEN.
"Knowledge is power and the new ASBrS guidelines send a strong
message to the breast cancer community that genetic testing is
appropriate for everyone diagnosed with breast cancer,” said Stacey
Tinianov, breast cancer survivor and community engagement and
advocacy consultant in Santa Clara, California. “I am
optimistic NCCN will consider the evidence and update its breast
cancer guidelines to ensure appropriate genetic testing becomes the
standard of care and is made broadly accessible."
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: 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.
Follow Myriad on Twitter via @MyriadGenetics.
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 recommendation by the American Society of
Breast Surgeons (ASBrS) of new guidelines that all people
diagnosed with breast cancer undergo genetic testing with a
multi-gene panel; the value of the information provided by
genetic testing in enhancing physicians’ ability to select
precision treatments, personalize care for patients and their
families and improve health outcomes; the possibility and timing of
NCCN updating its guidelines consistent with the new ASBrS
guidelines; 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; 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 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: |
Investor Contact: |
Ron Rogers |
Scott Gleason |
(801) 584-3065 |
(801) 584-1143 |
rrogers@myriad.com |
sgleason@myriad.com |
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