Myriad Receives FDA Approval of BRACAnalysis CDx(TM) as Companion Diagnostic for Lynparza(TM) (olaparib) in Ovarian Cancer Pa...
December 19 2014 - 12:10PM
Myriad Genetics, Inc. (Nasdaq:MYGN) today announced that it has
received approval from the U.S. Food and Drug Administration (FDA)
for BRACAnalysis CDx to be used as the only companion diagnostic in
conjunction with AstraZeneca's drug Lynparza™ (olaparib). Lynparza
is the first poly ADP-ribose polymerase (PARP) inhibitor for
patients with germline mutations in BRCA1/2 advanced ovarian cancer
who have had three or more lines of chemotherapy. BRACAnalysis CDx
is Myriad's first FDA-approved companion diagnostic for use with a
novel PARP inhibitor.
"Myriad is excited to offer the first and only FDA-approved
companion diagnostic for Lynparza, which we believe opens a new
door in personalized medicine and represents a big step forward in
tailoring treatment for women with ovarian cancer," said Mark
Capone, president, Myriad Genetic Laboratories. "Less than 25
percent of ovarian cancer patients know their germline BRCA status,
which is critical for any ovarian cancer patient who may be
considered for treatment with Lynparza."
BRACAnalysis CDx is a highly accurate molecular companion
diagnostic test that identifies deleterious or suspected
deleterious mutations in the BRCA1 and BRCA2 genes, using DNA
obtained from a blood sample. BRACAnalysis CDx was proven in
clinical studies to effectively identify patients with BRCA
mutations who would be candidates for Lynparza. The approval of
BRACAnalysis CDx demonstrates Myriad's commitment to developing
companion diagnostics and is the culmination of an intensive,
multiyear scientific collaboration with AstraZeneca to advance
personalized medicine for women with ovarian cancer.
"Myriad has proven its ability to navigate a rigorous FDA
regulatory approval process that included a comprehensive review of
our DNA sequencing, large rearrangement detection and variant
interpretation processes. Patients can be confident their
BRACAnalysis CDx test results from Myriad are highly accurate,"
said Capone. "Our scientific excellence, reputation for high
quality and regulatory experience are key reasons why Myriad is
fast becoming the partner of choice for many biopharmaceutical
companies seeking to co-develop companion diagnostic tests. We
hope to expand our collaborations and further diversify our product
portfolio."
Myriad is committed to being a leader in companion diagnostics
for personalized healthcare. The Company is actively
collaborating with several biopharmaceutical companies to further
evaluate BRACAnalysis CDx as an investigational companion
diagnostic for use with other PARP inhibitors and chemotherapeutic
agents and for use in many other solid tumor
types. BRACAnalysis CDx testing will be performed in Myriad's
laboratory in Salt Lake City, Utah. For more information,
please visit www.myriad.com or call customer service at
1-800-469-7423.
About BRACAnalysis CDx™
Intended Use: 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. Results of the test are
used as an aid in identifying ovarian cancer patients with
deleterious or suspected deleterious germline BRCA variants
eligible for treatment with Lynparza™ (olaparib). 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.
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 directives to grow our markets, introduce new
products, including companion diagnostics, as well as to expand
internationally. For more information on how Myriad is making a
difference, please visit the Company's websites:
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
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 an FDA-approved BRACAnalysis
CDx test providing additional assurance that patients are receiving
the most accurate test results and improving patient care by
identifying candidates for treatment with Lynparza (olaparib); the
Company's commitment to developing companion diagnostics; the
Company becoming the partner of choice for many biopharmaceutical
companies seeking to co-develop companion diagnostics; the
Company's hopes to expand its collaborations and further diversify
its portfolio; the Company's ongoing collaborations with
biopharmaceutical companies to further evaluate BRACAnalysis CDx
for use with other PARP inhibitors and chemotherapeutic agents and
for use in other solid tumor types; the location of BRACAnalysis
testing; 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 product portfolio to our new tests, 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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