German Federal Joint Committee (G-BA) Issues Nationwide
Reimbursement Decision for EndoPredict® Breast Cancer Prognostic
Test
Myriad Genetics, Inc. (NASDAQ: MYGN), a global leader in molecular
diagnostics and precision medicine, announced today that the German
Federal Joint Committee (G-BA) has successfully completed the
method evaluation assessment for the EndoPredict® breast cancer
prognostic test. The positive decision means that EndoPredict can
be made available to all patients with statutory health insurance
in Germany as a benefit of the statutory health insurance
scheme.
EndoPredict is a second-generation biomarker test
used to determine the risk of recurrence in patients with
early-stage breast cancer (ER+/HER2-). The genomic test helps
patients and physicians jointly decide for, or against,
chemotherapy when uncertainties exist in the assessment of the
expected benefit of chemotherapy.
"This decision (by G-BA) makes it possible for a
biomarker test to be carried out quickly in Germany, providing more
certainty with the difficult decisions relating to the pros and
cons of chemotherapy," says Univ Prof. Dr. Marion Kiechle, Director
of the Gynaecological Clinic of the University Hospital Rechts der
Isar of the TU Munich.
Every year, approximately 70,000 women in Germany
are diagnosed with early-stage, breast cancer. For up to 20,000 of
these patients, clinical-pathological criteria alone are not
sufficient to confidently make chemotherapy treatment decisions.
The Federal Joint Committee supports the use of biomarkers, now
including EndoPredict, to identify those patients who will likely
benefit from chemotherapy treatment.
EndoPredict has been part of the recommendations
of the leading national (AGO, S3) and international (St.Gallen,
ESMO, ASCO and NCCN) guidelines for many years and is already
available to affected women in public health systems in France,
England, Italy, Spain, Switzerland and Austria.
"We are pleased to make EndoPredict broadly
available to gynecologists and pathologists in Germany within the
framework of the GKV,” said Raymond Francot, executive vice
president of Myriad International. “This decision expands access to
critical, life-changing insights for patients and their providers,
and adds valuable information to aid in personalized treatment
selection.”
About EndoPredict®EndoPredict
is a second-generation, 12-gene molecular prognostic test for
patients diagnosed with breast cancer. The test provides vital
information that helps clinicians devise personalized treatment
plans for their patients. EndoPredict has been validated in more
than 4,000 patients with node-negative and node-positive cancer and
has been used clinically in more than 30,000 patients. In contrast
to first-generation multigene prognostic tests, EndoPredict detects
the likelihood of late metastases (i.e., metastasis formation after
more than five years) and, therefore, can guide treatment decisions
regarding the need for chemotherapy, as well as extended
anti-hormonal therapy. Accordingly, therapy decisions backed by
EndoPredict confer a high level of diagnostic safety. For more
information, please visit:
https://myriad-oncology.com/endopredict/
About Myriad
Genetics® Myriad Genetics Inc., is a
leading precision 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 three
strategic imperatives: transitioning and expanding its hereditary
cancer testing markets, diversifying its product portfolio through
the introduction of new products and increasing the revenue
contribution from international markets. 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 CDx, Vectra, Prequel, Foresight,
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 Statement This
press release contains "forward-looking statements" within the
meaning of the Private Securities Litigation Reform Act of 1995,
including statements related to EndoPredict being available to all
patients with statutory health insurance in Germany without
restrictions; EndoPredict being broadly available to gynecologists
and pathologists in Germany; G-BA’s decision expanding access to
critical, life-changing insights for patients and their providers;
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: uncertainties
associated with COVID-19, including its possible effects on our
operations and the demand for our products and services; our
ability to efficiently and flexibly manage our business amid
uncertainties related to COVID-19; 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
decisions in Mayo Collab. Servs. v. Prometheus Labs., Inc., 566
U.S. 66 (2012), Ass’n for Molecular Pathology v. Myriad Genetics,
Inc., 569 U.S. 576 (2013), and Alice Corp. v. CLS Bank Int’l, 573
U.S. 208 (2014); 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, 2020, 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: |
Jared
Maxwell |
|
Investor
Contact: |
Scott
Gleason |
|
(801)
505-5027 |
|
|
(801)
584-1143 |
|
jmaxwell@myriad.com |
|
|
sgleason@myriad.com |
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