Myriad’s Prequel™ Prenatal Screen Demonstrates High Performance Across All Fetal-Fraction Levels in Women Undergoing Noni...
November 11 2019 - 7:05AM
Myriad Genetics, Inc. (NASDAQ: MYGN, “Myriad” or the “Company”), a
global leader in molecular diagnostics and precision medicine,
today announced that a new study of the Prequel™ Prenatal Screen
was published online in the journal Ultrasound in Obstetrics and
Gynecology. The key finding is that Prequel without a
fetal-fraction threshold achieves high accuracy, while maintaining
a low test-failure rate of one in 1000. The Prequel Prenatal
Screen uses a whole genome sequencing approach to identify
chromosomal abnormalities including trisomies 21, 18 and
13.
“This is the largest study of Prequel to date and demonstrates
that it achieves high accuracy with an industry-low test failure
rate of 0.1 percent in a general population of pregnant women,”
said James Goldberg, M.D., board certified maternal fetal medicine
specialist, medical geneticist and chief medical officer of Myriad
Women’s Health. “For women who are overweight or have a
compromised placenta, the findings are especially relevant because
their pregnancies may have low fetal fraction.”
To assess the clinical performance of the Prequel Prenatal
Screen, the study retrospectively analyzed data from more than
58,000 women, including 572 who tested positive for an aneuploidy
or suspected aneuploidy (362 for trisomy 21, 142 for trisomy 18 and
68 for trisomy 13). Pregnancy outcomes were sought for all
screen-positive patients and for thousands of patients who screened
negative. Whereas some other NIPS offerings attempt to avoid
false-negative results at low fetal fraction by failing nearly five
percent of all samples, 999 out of every 1,000 women received a
result with a single run of Prequel. Importantly, the
clinical sensitivity and specificity levels observed with Prequel
were high and comparable to those reported for the other commercial
NIPS offerings that have the far higher test failure rates.
“What these findings mean is that Prequel performed comparably
in women with high and low fetal fractions, which should give
clinicians confidence in the results and help their patients make
informed choices,” said Dr. Goldberg. “Importantly, had a
fetal-fraction threshold been applied in this general population,
one in 15 women would have received no result, which would have
delayed the identification of chromosomal abnormalities and
potentially lead to anxiety and multiple rounds of unnecessary
invasive testing.”
About Prequel™ Prenatal ScreenThe Myriad
Prequel Prenatal Screen is a noninvasive prenatal screen (NIPS)
that uses cell-free DNA (cfDNA) to determine if a pregnancy is at
an increased risk for chromosome abnormalities, such as Down
syndrome. Compared to screening methods which use maternal
age, ultrasound and serum screening, Prequel has been shown to be
superior by achieving a lower false-positive rate and
false-negative rate than these other methods. Among other
NIPS, Prequel has an industry leading test failure rate of 0.1
percent. The Prequel Prenatal Screen can be ordered with the
Foresight Carrier Screen and offered to all women, including those
with high body mass index, and 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 CDx, 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 performance of the Prequel test; 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(801) 584-3065rrogers@myriad.com |
Investor Contact: |
Scott Gleason(801) 584-1143sgleason@myriad.com |
Myriad Genetics (NASDAQ:MYGN)
Historical Stock Chart
From Mar 2024 to Apr 2024
Myriad Genetics (NASDAQ:MYGN)
Historical Stock Chart
From Apr 2023 to Apr 2024