Myriad Applauds AACU Position Statement on Molecular Testing for Risk Stratification in Prostate Cancer
March 06 2018 - 7:05AM
Myriad Genetics, Inc. (NASDAQ:MYGN), a worldwide leader in
personalized medicine, announced today that the American
Association of Clinical Urologists (AACU) have issued a position
statement supporting molecular testing for prostate cancer
patients, which was also endorsed by the Large Urology Group
Practice Association (LUGPA). The statement supports tissue based
molecular testing for prostate cancer risk stratification in low
and favorable-intermediate risk men and germline testing for
hereditary cancer syndrome in prostate cancer patients with a
family history of cancer or high-risk disease.
“The AACU is very pleased to release our position
statement on genomic testing in prostate cancer. Together, with
LUGPA, our organizations represent more than 70 percent of
urologists in the United States. The statement is in close
alignment with the recently updated NCCN prostate cancer
guidelines. Importantly, it sends a message to policy makers,
researchers, payers and patients and their families that we are
committed to applying the best available science to the detection,
risk stratification and appropriate treatment of prostate cancer,”
said Mark T. Edney, M.D., MBA, chair, State Advocacy Network
at the AACU. “Further, our organizations seek to assist in
finding the families who reside in our communities who may be
harboring crucial and unknown hereditary genes that may affect
their cancer risk, that of their relatives, and of future
generations.”
Below are the recommendations stated in the AACU
position paper:
- Tissue-based molecular testing for risk stratification should
be considered for low and favorable-intermediate risk men with life
expectancy ≥ 10 years.
- Germline testing should be considered in men with very-low
risk, low risk, favorable and unfavorable intermediate risk
prostate cancer and strong family history. Germline testing also
should be considered, irrespective of family history, in men with
metastatic disease or those with high risk or very-high risk
regional disease.
The position paper issued by AACU and endorsed by LUGPA is
consistent with recently issued National Comprehensive Cancer
Network (NCCN) guidelines supporting biomarker based testing in
prostate cancer. Myriad has the market leading prostate cancer
prognostic test Prolaris® and the market leading hereditary cancer
risk assessment test myRisk® Hereditary Cancer.
“With recent endorsements from NCCN, AACU, and LUGPA, Prolaris
and myRisk Hereditary Cancer testing should now be considered
standard-of-care tests to help guide key decision making for
prostate cancer patients,” said Nicole Lambert, general manager,
Urology at Myriad Genetics. “We are highly optimistic that
these broadly supported recommendations will lead to expanded
reimbursement coverage and improved patient access to these
important tests.”
About American Association of Clinical
Urologists: About the American Association of Clinical
Urologists: Founded in 1968 by urologists concerned by the
government's increasing role in the practice of medicine, the
American Association of Clinical Urologists (AACU) is the only
national organization to serve urology with the sole purpose of
promoting and preserving the professional autonomy and financial
viability of each of its members. The AACU is dedicated to
developing and advancing health policy education as it affects
urologic practice in order to preserve and promote the professional
autonomy of its members and support the highest quality of care for
patients. The AACU is a member of the American Medical Association
Federation of Medicine and proud sponsor of UROPAC.
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 critical success factors: building 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 relating to the American Association of Clinical
Urologists (AACU) position statement and recommendations supporting
molecular testing for prostate cancer patients; the Company’s
optimism that these broadly supported recommendations will lead to
expanded reimbursement coverage and improved patient access to
these important tests; 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 our 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 Annual report on Form 10-K for the fiscal year ended
June 30, 2017, 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
(801) 584-3065
rrogers@myriad.com
Investor Contact:Scott Gleason(801)
584-1143sgleason@myriad.com
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