Myriad and AstraZeneca Expand Research Collaboration on Lynparza
April 01 2015 - 7:05AM
Myriad Genetics, Inc. (Nasdaq:MYGN) today announced the expansion
of its companion diagnostic collaboration with AstraZeneca. Under
the terms of the expanded agreement, Myriad's BRACAnalysis CDx test
will be used to prospectively identify which patients with
metastatic pancreatic cancer may respond to treatment with
Lynparza™ (olaparib).1 Lynparza is a PARP (poly-ADP ribose
polymerase) inhibitor being developed by AstraZeneca. More than
48,000 people are diagnosed with pancreatic cancer and more than
40,000 will die from the disease each year in the United States.2
"Pancreatic cancer is one of the few cancers for which survival
has not improved substantially in the last 40 years, and the
average life expectancy after diagnosis with metastatic disease is
three to six months," said Mark Capone, president, Myriad Genetic
Laboratories. "Our collaboration with AstraZeneca is a big step
forward in the fight against pancreatic cancer and in ensuring that
personalized medicine becomes reality. BRACAnalysis CDx has
the potential to quickly and accurately identify those patients who
may be candidates for treatment with Lynparza and hopefully to
accelerate better health outcomes."
In December 2014, the U.S. Food and Drug Administration (FDA)
approved BRACAnalysis CDx to identify ovarian cancer patients with
germline mutations in BRCA1/2 who may be appropriate for treatment
with Lynparza. The approval of BRACAnalysis CDx was the first
time the FDA has approved a complex laboratory developed test (LDT)
under the premarket approval application process and was the
first-ever approval of an LDT companion diagnostic test.
1 A Phase III, Randomised, Double Blind, Placebo
Controlled, Multicentre Study of Maintenance Olaparib Monotherapy
in Patients With gBRCA Mutated Metastatic Pancreatic Cancer Whose
Disease Has Not Progressed on First Line Platinum Based
Chemotherapy.
(https://clinicaltrials.gov/ct2/show/NCT02184195?term=olaparib+pancreatic+cancer&rank=2)
2 American Cancer Society website. Data accessible online at:
www.cancer.org/cancer/pancreaticcancer/detailedguide/pancreatic-cancer-key-statistics
About BRACAnalysis CDx™
BRACAnalysis CDx™ is an FDA-approved 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.
About Myriad Genetics
Myriad Genetics is a leading molecular diagnostic company
dedicated to making a difference in patients' lives through the
discovery and commercialization of transformative tests to assess a
person's risk of developing disease, guide treatment decisions, and
assess risk of disease progression and recurrence. Myriad is
focused on strategic initiatives to grow existing markets,
diversify through the introduction of new products, including
companion diagnostics, and expand internationally. 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, myRisk Hereditary Cancer, myChoice, myPlan Lung
Cancer, BRACAnalysis CDx, HRD, Vectra and Prolaris are trademarks
or registered trademarks of Myriad Genetics, Inc. in the United
States and foreign countries. MYGN-F, MYGN-G
Note to Editors:
Lynparza is a trademark of AstraZeneca.
Safe Harbor Statement
This press release contains "forward-looking statements" within
the meaning of the Private Securities Litigation Reform Act of
1995, including statements relating to BRACAnalysis CDx testing
being used in clinical trials of patients with pancreatic cancer to
prospectively identify which patients may respond to treatment with
Lynparza; the BRACAnalysisCDx test improving patient care by
identifying candidates for treatment with Lynparza; and the
Company's strategic directives under the caption "About Myriad
Genetics." 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 or will not continue to increase at historical rates; risks
related to our ability to transition from our existing to new
testing services, including unexpected costs and delays; risks
related to changes in the 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;
risks related to public concern over our 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 Annual Report on Form 10-K for the fiscal year ended
June 30, 2014, 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.
CONTACT: Media Contact:
Ron Rogers
(801) 584-3065
rrogers@myriad.com
Investor Contact:
Scott Gleason
(801) 584-1143
sgleason@myriad.com
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