Myriad Receives FDA Approval of myChoice CDx® as Companion Diagnostic for Lynparza™ (olaparib) In Patients with Advanced O...
May 11 2020 - 7:05AM
Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in molecular
diagnostics and precision medicine, today announced that
the U.S. Food and Drug Administration (FDA) approved the
myChoice CDx® test for use as a companion diagnostic by
healthcare professionals to identify advanced ovarian cancer
patients with positive homologous recombination deficiency (HRD)
status, who are eligible or may become eligible, for first-line
maintenance treatment with Lynparza (olaparib) in combination with
bevacizumab. Lynparza (olaparib) is a novel PARP inhibitor jointly
developed and commercialized by AstraZeneca (LSE/STO/NYSE: AZN) and
Merck, known as MSD outside of the U.S. and Canada.
“We congratulate AstraZeneca and Merck on obtaining
another FDA approval of Lynparza for women with advanced ovarian
cancer,” said Nicole Lambert, president of Myriad Oncology and
Women’s Health. “The approval of the myChoice CDx test will help
clinicians quickly identify the potential one in two women whose
ovarian cancer is HRD positive and who will likely respond to
targeted therapy.”
myChoice CDx is the most comprehensive HRD test and identifies
people with tumors that have lost the ability to repair
double-stranded DNA breaks, resulting in increased susceptibility
to DNA-damaging drugs such as PARP inhibitors. In the PAOLA-1
trial, which compared the efficacy of Lynparza in combination with
bevacizumab versus bevacizumab alone, enrolled patients were tested
by the myChoice CDx test.
“The approval of the myChoice CDx test builds on our shared goal
with Myriad to accelerate precision diagnosis and treatment for
women with advanced ovarian cancer,” said Ruth March, senior vice
president, Precision Medicine, AstraZeneca. “We are excited that
women with advanced ovarian cancer who test positive for HRD with
the myChoice CDx test at time of diagnosis can now
access Lynparza in the first-line maintenance treatment
setting in combination with bevacizumab.”
Myriad has been collaborating with AstraZeneca since 2007 on the
development of companion diagnostics for Lynparza. Lynparza is a
trademark of AstraZeneca.
About Ovarian CancerOvarian cancer is the
eighth most common cause of death from cancer in women worldwide.
In 2018, there were nearly 300,000 new cases diagnosed and around
185,000 deaths. Most women are diagnosed with advanced (Stage III
or IV) ovarian cancer and have a five-year survival rate of
approximately 30 percent. For patients with advanced ovarian
cancer, the primary aim of first-line treatment is to delay
progression of the disease for as long as possible and maintain the
patient’s quality of life with the intent of achieving complete
remission.
About myChoice CDxMyriad's myChoice CDx is the
most comprehensive homologous recombination deficiency test,
enabling physicians to identify patients with 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 CDx test comprises tumor
sequencing of the BRCA1 and BRCA2 genes and a composite of three
proprietary technologies (loss of heterozygosity, telomeric allelic
imbalance and large-scale state transitions).
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 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, Prolaris and
riskScore 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 to helping clinicians quickly identify the
potential one in two women whose ovarian cancer is HRD positive and
potentially eligible for targeted therapy; accelerating precision
diagnosis and treatment for women with advanced ovarian cancer;
patients being able to access Lynparza in the first-line
maintenance treatment setting in combination with bevcizumab; 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, 2019, 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(801)
505-5027jmaxwell@myriad.com
Investor Contact: Scott Gleason(801)
584-1143sgleason@myriad.com
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