FDA Approves Myriad’s myChoice® CDx Test to Help Identify Women Eligible for Treatment with Zejula® in Late-line Ovarian ...
October 23 2019 - 5:40PM
Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in molecular
diagnostics and precision medicine, announced that the U.S.
Food and Drug Administration (FDA) approved myChoice® CDx for
use as a companion diagnostic by healthcare professionals to
identify women with advanced ovarian cancer who are candidates for
Zejula® (niraparib) in the late-line treatment setting.
GlaxoSmithKline also announced that it received
approval from the FDA for an expanded indication for Zejula for the
treatment of advanced ovarian, fallopian tube, or primary
peritoneal cancer patients, who have been treated with three or
more prior chemotherapy regimens and whose cancer is associated
with homologous recombination deficiency. Today’s
announcement marks the first FDA-approval for myChoice CDx, which
is the only FDA-approved tumor test for this indication.
“We congratulate GlaxoSmithKline on its FDA
approval of Zejula for women with ovarian cancer,” said Jerry
Lanchbury, Ph.D., chief scientific officer of Myriad.
“Today’s approval marks a historic milestone for the myChoice CDx
test after more than 10 years of development and demonstrates
Myriad’s commitment to pioneering science and collaboration with
pharmaceutical partners in order to accelerate precision therapies
for people with cancer.”
myChoice CDx is the first and only tumor test that
determines homologous recombination deficiency status by detecting
BRCA1 and BRCA2 (sequencing and large rearrangement) variants with
comprehensive assessment of genomic instability using three
critical biomarkers: loss of heterozygosity, telomeric allelic
imbalance and large-scale state transitions.
“Women with advanced ovarian cancer who have had
multiple rounds of chemotherapy have limited treatment options and
today’s approval offers new hope,” said Nicole Lambert, president
of Myriad Oncology. “We look forward to working with the
medical community to make the myChoice CDx test widely accessible
and in helping clinicians determine whether their patients are
eligible for treatment with Zejula.”
Approximately 22,000 women are diagnosed each year
with ovarian cancer in the United States. Ovarian cancer is the
fifth most frequent cause of cancer death among women. Despite high
response rates to platinum-based chemotherapy in the frontline,
approximately 85 percent of patients will experience disease
recurrence. Once the disease recurs, it is considered incurable
with time to each future recurrence getting shorter.
Late-line treatment options for women with ovarian cancer are few,
with the proportion of patients achieving an overall response
typically less than 10 percent when treated with chemotherapy.
About myChoice® CDxmyChoice
CDx is an FDA-approved companion diagnostic test for use by
healthcare professionals to identify women with advanced ovarian
cancer who are candidates for ZEJULA in the late-line treatment
setting. myChoice CDx is the first and only comprehensive
tumor test that determines homologous recombination deficiency
status by detecting BRCA1 and BRCA2 (sequencing and large
rearrangement) variants and assessing genomic instability using
three critical biomarkers: loss of heterozygosity, telomeric
allelic imbalance and large-scale state transitions.
About Myriad GeneticsMyriad 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
five critical success factors: building 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.
ZEJULA is a registered trademark of TESARO, Inc. For full
prescribing information visit www.zejula.com/hcp
Safe Harbor StatementThis press release
contains “forward-looking statements” within the meaning of the
Private Securities Litigation Reform Act of 1995, including
statements relating to the U.S. Food and Drug Administration’s
approval of myChoice® CDx as a companion
diagnostic to niraparib for use in ovarian cancer patients;
accelerate precision therapies for people with cancer; making the
myChoice CDx test widely accessible; 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, 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: |
Ron
Rogers |
Investor
Contact: |
Scott
Gleason |
|
(801)
584-3065 |
|
(801)
584-1143 |
|
rogers@myriad.com |
|
sgleason@myriad.com |
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