Myriad Genetics, Inc. (NASDAQ: MYGN), a global leader in
personalized medicine, today announced that the United Kingdom’s
(UK) National Institute for Health and Care Excellence (NICE) has
included EndoPredict® in its recommendations for guiding adjuvant
chemotherapy decisions for people with ER-positive, HER2-negative
early breast cancer and who are lymph node-negative.
“I am delighted that NICE has approved the use of EndoPredict to
help us decide which breast cancer patients are most likely to
benefit from chemotherapy and, equally importantly, which patients
can avoid it,” said Mr. Simon Marsh, M.D., FRCS, consultant breast
surgeon at Colchester Hospitals University NHS Foundation Trust.
“I would envisage that using EndoPredict will increase the
quality of care we can give to our patients with breast cancer and
it marks another step along the road to truly personalised cancer
treatment.”
After an extensive technical review, NICE concluded that the
clinical evidence justifies EndoPredict for patients with
intermediate risk of distant recurrence as determined by a
validated tool such as PREDICT or the Nottingham Prognostic
Index. The information provided by the EndoPredict test will
help patients choose, with their clinician, whether or not to
pursue adjuvant chemotherapy.
“We are excited that NICE has acknowledged the clinical benefits
of the EndoPredict test for people with early breast cancer,” said
Ralf Kronenwett, M.D., Ph.D., director of International Medical
Affairs, Myriad Genetics. “The NICE recommendation is the
result of years of hard work and research by many people to advance
cancer care for patients in the UK.”
Earlier this month, Myriad presented important new data at the
San Antonio Breast Cancer Symposium (SABCS) which demonstrated that
EndoPredict is the only test to answer three critical questions for
patients: risk of breast cancer recurrence, benefits of
chemotherapy and risk of late metastasis to identify patients who
can safely avoid extended endocrine therapy. Additionally,
academic researchers from the Technical University of Munich
presented new prospective outcomes data at SABCS. The key
finding is that patients with a high EndoPredict test score had a
better outcome with adjuvant chemotherapy compared to endocrine
therapy alone.
About Breast Cancer in the United
KingdomAccording to Cancer Research UK, 1 in 8 women are
still predicted to get breast cancer at some point in their
lives. There are approximately 55,000 new cases of breast
cancer diagnosed in the UK each year. Of those, it is
estimated that approximately 14,000 patients per year are diagnosed
with intermediate risk for distant recurrence.
About EndoPredict®EndoPredict is a
third-generation, multigene prognostic test that combines genetic
information from the tumor with important clinical features to help
clinicians personalize treatment plans 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 25,000
patients. In contrast to first-generation multigene
prognostic tests, EndoPredict is validated to accurately predict
both early (0-5) and late (5-15 years) distant recurrence and for
prediction of benefit from both adjuvant chemotherapy as well as
which patients can safely forgo extended endocrine therapy beyond
five years. EndoPredict is manufactured by Myriad Genetics,
Inc.
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: build upon a solid hereditary cancer foundation,
grow new product volume, expand reimbursement coverage for new
products, increase RNA kit revenue internationally and improve
profitability with Elevate 2020.
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 Prelude 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.
Oncotype Dx is a registered trademark of Genomic Health,
Inc.
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 National Institute for Health and Care
Excellence including EndoPredict in its recommendations for guiding
adjuvant chemotherapy decisions for people with ER-positive,
HER2-negative early breast cancer and who are lymph node-negative;
the ability of EndoPredict to answer three critical questions for
patients: risk of breast cancer recurrence, benefits of
chemotherapy and risk of late metastasis to identify patients who
can safely avoid extended endocrine therapy; the finding that
patients with a high EndoPredict test score had a better outcome
with adjuvant chemotherapy compared to endocrine therapy
alone; 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: Ron Rogers
(801)
584-3065
rrogers@myriad.com
Investor Contact: Scott Gleason(801)
584-1143sgleason@myriad.com
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