NCCN Guidelines Broadly Endorse Biomarker Testing in Prostate Cancer
February 20 2018 - 7:05AM
Myriad Genetics, Inc. (NASDAQ:MYGN) today announced that the
National Comprehensive Cancer Network (NCCN) has updated its
medical guidelines for prostate cancer treatment to broadly include
biomarker testing in prostate cancer. The changes to the guidelines
include new language
supporting Prolaris
® as standard of care
in treatment decision making for patients with low
and favorable-intermediate risk prostate cancer.
Additionally, the new guidelines support an expansion of
hereditary cancer testing for prostate cancer to include all
patients with a family history regardless of Gleason
score along with all patients with metastatic disease,
and new recommendations supporting testing for homologous
recombination deficiency (HRD) in patients with metastatic prostate
cancer.
“We view this significant update in guidelines as a clear
indication of the increasing importance of molecular biomarkers in
guiding prostate cancer care and Myriad is uniquely positioned with
its broad portfolio of tests to address these clinical needs,” said
Nicole Lambert, general manager, Urology. “These new
guidelines are critical in our efforts to broaden insurance
coverage and increase patient access to Myriad’s entire portfolio
of prostate cancer molecular diagnostic tests.”
Below are the key updates from the guidelines:
- Prolaris: now standard of care for 110,000 patients per year
identified as low or favorable-intermediate risk patients.
- myRisk Hereditary Cancer: now recommended
for approximately 70,000 prostate
cancer patients per year including all patients
with metastatic prostate cancer and those with a family history of
cancer regardless of Gleason score.
- myChoice HRD: now recommended for 20,000 patients per year with
metastatic prostate cancer to identify tumors with homologous
recombination deficiency (HRD) so that these patients can be
considered for targeted therapies.
About Prolaris®Prolaris is a
novel 46-gene RNA-expression test that directly measures tumor cell
growth characteristics for stratifying the risk of disease
progression in patients with prostate cancer. Prolaris provides a
quantitative measure of the RNA expression levels of genes involved
in the progression of tumor growth. Low gene expression is
associated with a low risk of disease progression in men who may be
candidates for active surveillance and high gene expression is
associated with a higher risk of disease progression in patients
who may benefit from additional therapy. For more information
visit: www.prolaris.com.
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 the development of
eight hereditary cancers 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,
a medical management tool 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
therefore eligible for myRisk Hereditary Cancer test.
About myChoice®
HRD Myriad's myChoice HRD is the most
comprehensive homologous recombination deficiency test, enabling
physicians to identify tumors that have lost the ability to repair
double-stranded DNA breaks, resulting in increased susceptibility
to DNA-damaging drugs such as platinum drugs or PARP inhibitors.
The myChoice HRD test is a composite of three proprietary
technologies (loss of heterozygosity, telomeric allelic imbalance
and large-scale state transitions).
Positive myChoice HRD scores, reflective of DNA repair
deficiencies, are prevalent in all breast cancer subtypes, ovarian
cancer and most other major cancers. It is estimated that 1.4
million people in the United States and Europe who are diagnosed
with cancers annually may be candidates for treatment with
DNA-damaging agents. Learn more: https://mychoicehrd.com/
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 relating to the new guidelines supporting an expansion
of hereditary cancer testing for prostate cancer to include all
patients with a family history regardless of Gleason score along
with all metastatic patients; the increasing importance of
molecular biomarkers in guiding prostate cancer care and the
Company being uniquely positioned with its broad portfolio of tests
to address these clinical needs; the Company’s efforts to broaden
insurance coverage and increase patient access to the Company’s
entire portfolio of prostate cancer molecular markers; the
anticipated number of prostate cancer patients now indicated for
Prolaris®, myRisk® Hereditary Cancer, and myChoice® HRD testing
under the new NCCN guidelines; 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
(801) 584-3065
rrogers@myriad.com
Investor Contact:Scott Gleason(801)
584-1143sgleason@myriad.com
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