Myriad Genetics, Inc. (NASDAQ:MYGN) today announced that a
comparative analysis of commercially available prognostic breast
cancer tests in patients with early-stage breast cancer has been
published in JAMA Oncology. A key finding is that
Myriad’s EndoPredict
® (EPClin) significantly
outperformed Oncotype DX® Recurrence Score at predicting the risk
of disease recurrence in patients with early-stage breast cancer.
In the article, Sestak et al. compared the prognostic value that
four different commercial tests add to the Clinical Treatment Score
(nodal status, tumor size, grate, age, endocrine treatment) for
predicting distant recurrence (0-10 years) and late-distant
recurrence (5-10 years) of breast cancer. The analysis
included data from 774 postmenopausal women with ER+/HER2- breast
cancer with node-negative disease or up to three positive lymph
nodes, which is the most common form of breast cancer.
The results show that in all patients EndoPredict was the best
overall test in predicting distant recurrence in years 0-10
(C-index 0.753; LRX2=69.3) and years 5-10 (C-index 0.761;
LRX2=41.6). Importantly, EndoPredict identified the largest
group of low-risk patients with 10 years distant recurrence below
10 percent in both node-negative and node-positive disease.
EndoPredict also was a much better predictor for overall distant
recurrence and for late-distant recurrence than Oncotype DX
Recurrence Score. The JAMA Oncology publication can be
accessed at: https://doi.org/10.1001/jamaoncol.2017.5524.
“This study demonstrates that EndoPredict, which combines a
multigene signature with clinical information, significantly
improves the prediction of disease recurrence, specifically in
women with node-positive breast cancer,” said Johnathan Lancaster,
M.D., Ph.D., chief medical officer, Myriad Genetics. “What
this means is that EndoPredict can more accurately identify a
larger percentage of patients who can safely forgo adjuvant
chemotherapy and the associated toxicity.”
These findings are consistent with a previous publication in the
Journal of the National Cancer Institute, which also found that
EndoPredict was superior to Oncotype DX Breast Recurrence Score in
predicting the long-term recurrence of ER+, HER2- primary breast
cancer.
Additionally, at the 2017 San Antonio Breast Cancer Symposium in
December, the Company presented new predictive data that
demonstrated women with a high EndoPredict score responded better
to neoadjuvant chemotherapy than those with a low score, while
those with a low score responded better to neoadjuvant endocrine
therapy.
“We are committed to saving and improving the lives of women
with breast cancer, and making sure patients are benefitting from
the latest advances in personalized medicine,” said Lancaster.
“Our expanding body of evidence strongly supports the use of
EndoPredict to aid in clinical decisions regarding the use of
chemotherapy and extended endocrine therapy.”
EndoPredict is widely accessible and is covered by more than 90
percent of health insurance plans in the United States. It
also is available in several major European markets. For more
information, please visit: www.endopredict.com.
Follow Myriad on Twitter via @MyriadGenetics to stay informed
about news and updates from the Company.
Medical Policy UpdateOne of the largest private
insurers in the United States has expanded its coverage policy on
EndoPredict. The new policy supports the use of EndoPredict
to aid in the controversial decision of whether or not to extend
adjuvant hormonal therapy beyond five years of treatment.
“I applaud payers for recognizing the importance of biomarkers
to help physicians and patients make important decisions about
whether or not to use extended endocrine therapy out to 10 years,”
said Joyce A. O'Shaughnessy, M.D., Celebrating Women Chair in
Breast Cancer Research, Baylor University Medical Center, and Chair
of Breast Cancer Research at Texas Oncology. “This is another
important step toward making personalized medicine a reality for
all patients with breast cancer.”
About Breast CancerOne in eight American women
will have breast cancer during her lifetime. Breast cancer is the
second leading cause of cancer death among American women.
The American Cancer Society estimates in its Cancer Facts
& Figures 2018 report that more than 250,000 women will be
told they have breast cancer in 2018. Currently, there are
nearly 3.5 million American women living with the disease and every
13 minutes another American woman dies from breast cancer. That’s a
little more than 40,000 this year.
About EndoPredictEndoPredict is a
second-generation, multigene prognostic test that aids personalized
treatment planning for patients with early stage breast
cancer. EndoPredict has been validated in approximately 4,000
patients with node-negative and node-positive disease and has been
used clinically in more than 20,000 patients. In contrast to
first-generation multigene prognostic tests, EndoPredict accurately
predicts the likelihood of both early (0-5 years) and late distant
recurrence (5-10 years). Thus, EndoPredict can guide treatment
decisions on both the need for chemotherapy, as well as extended
endocrine therapy. For more information, please visit:
www.endopredict.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 related the ability of EndoPredict to identify a larger
percentage of patients who can safely forgo adjunctive chemotherapy
and the associated toxicity; the significant improvement
EndoPredict provides in the prediction of disease recurrence,
specifically in women with node-positive breast cancer; a national
payer’s expanded coverage policy on EndoPredict; 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
Investor
Contact: Scott Gleason
(801) 584-3065
(801)
584-1143
rrogers@myriad.com
sgleason@myriad.com
Myriad Genetics (NASDAQ:MYGN)
Historical Stock Chart
From Aug 2024 to Sep 2024
Myriad Genetics (NASDAQ:MYGN)
Historical Stock Chart
From Sep 2023 to Sep 2024