Myriad, AstraZeneca and Merck Expand Companion Diagnostic Partnership
April 04 2019 - 7:05AM
Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in personalized
medicine, today announced that it has expanded its companion
diagnostic collaboration with AstraZeneca and Merck (known as MSD
outside the US and Canada).
Under the expanded collaboration, the companies will use
BRACAnalysis CDx® to identify germline BRCA mutations in men who
have metastatic castrate-resistant prostate (mCRPC) cancer and are
enrolled in the Phase III PROfound (NCT02987543) study. If
the study is successful, Myriad intends to file a supplementary
premarket approval application with U.S. Food and Drug
Administration (FDA) for BRACAnalysis CDx to be used as a companion
diagnostic to Lynparza® (olaparib) for its use in this patient
population.
"Our companion diagnostic collaboration with AstraZeneca and
Merck has led to significant advancements in precision treatment
for patients with ovarian, breast cancer,” said Nicole Lambert,
president, Myriad Oncology. “However, there is a significant
unmet medical need in men with metastatic castration-resistant
prostate cancer and BRCA1/2 mutations, which is an area where the
utility of PARP inhibitors is being explored. We look forward
to this exciting opportunity to potentially expand the use of
BRACAnalysis CDx in this setting."
The collaboration between Myriad and AstraZeneca on Lynparza
began in 2007 and has resulted in multiple regulatory approvals for
BRACAnalysis CDx.
- February 2019: The Japanese Ministry of
Health, Labour, and Welfare approved BRACAnalysis CDx as a
companion diagnostic to identify patients with germline BRCA
mutated (BRCAm) advanced ovarian cancer who are eligible for
first-line maintenance therapy with Lynparza.
- December 2018: FDA approved BRACAnalysis CDx
as a companion diagnostic to identify patients with germline BRCAm
advanced ovarian cancer in complete or partial response to
first-line platinum-based chemotherapy and who are eligible for
first-line maintenance treatment with Lynparza.
- March 2018: The Japanese Ministry of
Health, Labour, and Welfare approved BRACAnalysis CDx as a
companion diagnostic to identify patients with germline BRCAm
metastatic breast cancer who have been previously treated with
chemotherapy and are eligible for treatment with Lynparza.
- January 2018: FDA approved BRACAnalysis
CDx as a companion diagnostic to identify patients with germline
BRCAm metastatic breast cancer who have been previously treated
with chemotherapy and are eligible treatment with
Lynparza.
- August 2017: FDA approved BRACAnalysis
CDx as a complementary diagnostic to identify patients with
recurrent platinum-sensitive germline BRCAm ovarian cancer who are
eligible for maintenance treatment with Lynparza.
- Dec. 2014: FDA approved BRACAnalysis CDx
as a companion diagnostic to identify patients with advanced
germline BRCAm ovarian cancer who have been treated with 3 or more
lines of chemotherapy and are eligible for treatment with
Lynparza.
Follow Myriad on Twitter via @myriadgenetics to keep up to date
with company news and updates.
About Prostate CancerAccording to the American
Cancer Society, about 174,650 new cases of prostate cancer will be
diagnosed in the United States in 2019, and there will be 42,970
new cases of mCRPC. Prostate cancer is the second leading cause of
cancer death in American men.
About BRACAnalysis CDx®BRACAnalysis CDx is an
in vitro diagnostic device intended for the qualitative detection
and classification of variants in the protein coding regions and
intron/exon boundaries of the BRCA1 and BRCA2 genes using genomic
DNA obtained from whole blood specimens collected in EDTA.
Single nucleotide variants and small insertions and deletions
(indels) are identified by polymerase chain reaction (PCR) and
Sanger sequencing. Large deletions and duplications in BRCA1
and BRCA2 are detected using multiplex PCR. This assay is for
professional use only and is to be performed only at Myriad Genetic
Laboratories, a single laboratory site located at 320 Wakara Way,
Salt Lake City, UT 84108. Learn more at:
http://myriadmychoice.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, Prolaris,
ForeSight and Prequel 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.
Lynparza® is a registered trademark of AstraZeneca.
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 ability of the BRACAnalysis CDx test to
identify patients with metastatic castrate-resistant prostate
cancer who may benefit from treatment with Lynparza; the
importance of the BRACAnalysis CDx test for this patient population
and the ability to identify patients likely to benefit from PARP
inhibition therapy; 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
(908) 285-0248
rrogers@myriad.com
Investor Contact: Scott
Gleason(801) 584-1143sgleason@myriad.com
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