Myriad Announces Prequel™ Prenatal Screen with Expanded Aneuploidy Analysis for all 23 Chromosome Pairs
February 11 2019 - 7:05AM
Myriad Genetics, Inc. (NASDAQ: MYGN), a global leader in
personalized medicine, today announced that its Myriad Women’s
Health subsidiary has enhanced the Prequel
TM
Prenatal Screen to include all 23 chromosome pairs rather than just
the standard five chromosomes (13, 18, 21, X and Y) previously
tested. Aneuploidies refer to extra or missing chromosomes
that can lead to poor reproductive health outcomes. The
expanded Prequel screen will be available to clinicians and
patients starting Feb. 19, 2019.
“The goal of noninvasive prenatal screening (NIPS) is to provide
women with information about the health of the pregnancy,” said
James Goldberg, M.D., board certified medical geneticist and chief
medical officer, Myriad Women’s Health. “Our expanded Prequel
Prenatal Screen now provides patients with a comprehensive
assessment of all 23 chromosome pairs for aneuploidies, which
improves the detection of aneuploidies by about 30 percent,
expanding the clinical utility of the screen.”
Prequel Prenatal Screen with expanded aneuploidy analysis can
potentially improve birth outcomes by identifying more pregnancies
at risk for birth defects and syndromes, as well as those at risk
for pregnancy complications due to these chromosome changes in the
placenta. This improves the opportunity for better monitoring,
specialized ultrasounds and targeted prenatal diagnosis.
“Every woman who wants to know more about her pregnancy should
be offered the Prequel Prenatal Screen,” said Goldberg. “In
addition to testing all 23 chromosome pairs, Prequel has an
industry-leading low test failure rate of 0.1 percent, which means
patients receive reliable results the first time without the need
for retesting.”
About PrequelTM Prenatal ScreenThe Myriad
Prequel Prenatal Screen is a noninvasive prenatal screen that uses
cell-free DNA (cfDNA) to determine if a pregnancy is at an
increased risk for chromosome abnormalities, such as Down
syndrome. Prequel has been shown to be superior to screening
methods that use maternal age, ultrasound and serum
screening. Additionally, Prequel has a lower false-positive
rate and false-negative rate than these other methods. The
Prequel Prenatal Screen can be ordered with the Foresight Carrier
Screen and offered to all women, including those with high body
mass index, an ovum donor, or a twin pregnancy.
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.
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 launch of the PrequelTM
Prenatal Screen to include all 23 chromosome pairs rather than just
the standard five chromosomes (13, 18, 21, X and Y) previously
tested; the expanded Prequel screen being available to clinicians
and patients starting Feb. 19, 2019; the expanded Prequel Prenatal
Screen now providing patients with a comprehensive assessment of
all 23 chromosome pairs for aneuploidies, improving the detection
of aneuploidies by about 30 percent, and expanding the clinical
utility of the screen; the potential of the Prequel Prenatal Screen
with expanded aneuploidy analysis to improve birth outcomes by
identifying more pregnancies at risk for birth defects and
syndromes, as well as those at risk for pregnancy complications due
to these chromosome changes in the placenta; the Prequel testing
having a low test failure rate of 0.1 percent, meaning patients
receive reliable results the first time without the need for
retesting; 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: |
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Ron Rogers |
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Investor Contact: |
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Scott Gleason |
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(801) 584-3065 |
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(801) 584-1143 |
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rrogers@myriad.com |
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sgleason@myriad.com |
1 Pescia, G. et al. Cell-free DNA testing of an extended range
of chromosomal anomalies: clinical experience with 6,388
consecutive cases. Genet. Med. (2016). doi:10.1038/gim.2016.72
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