Myriad’s Prequel™ Prenatal Screen has Superior Sensitivity in Women with High BMI Undergoing Non-Invasive Prenatal Screen...
04 December 2019 - 11:05PM
Myriad Genetics, Inc. (NASDAQ: MYGN, “Myriad” or the “Company”), a
global leader in molecular diagnostics and precision medicine,
announced that a new study of the Prequel™ Prenatal Screen was
published online in the journal Prenatal Diagnosis. The key
finding is that Prequel is superior to traditional non-DNA
screening for identifying chromosomal abnormalities in pregnant
women, including those with high body mass index (BMI). The
Prequel Prenatal Screen uses a proprietary whole genome sequencing
(WGS) approach to identify chromosomal abnormalities including
trisomy 21, trisomy 18 and trisomy 13.
“Approximately 50 percent of pregnant women in the
United States have a BMI that can negatively affect the accuracy of
NIPS, leading to patient anxiety and more invasive and expensive
screening methods. For example, some laboratories using
technologies with lower sensitivity require a four percent fetal
fraction cutoff that can result in a no call rate of up to 24
percent in women with a high BMI,” said James Goldberg, M.D., board
certified maternal fetal medicine specialist, medical geneticist
and chief medical officer of Myriad Women’s Health. “In our
study, we demonstrated that the Prequel Prenatal Screen delivers
accurate results to women irrespective of their body size, race or
ethnicity and significantly outperforms NIPS offerings using a four
percent fetal fraction cutoff and traditional non-DNA screening
methods.”
Specifically, this large study in 58,105 women modeled the clinical
performance of the Prequel Prenatal Screen in women with different
BMI levels and compared to both traditional non-DNA aneuploidy
screening and NIPS technologies with a fetal fraction (FF)
cutoff. The results demonstrated that Prequel outperformed
traditional screening for identifying chromosomal abnormalities,
including T13, T18 and T21 and was a superior screening option for
women with high BMI (Graph 1).
To view Graph 1: Prequel Prenatal Screen Is Most Sensitive
for Women at All BMI Levels, please visit the following
link: https://www.globenewswire.com/NewsRoom/AttachmentNg/2e49dec9-3c9f-46bd-8d38-360c3a64ea4c
“In prior studies, we demonstrated that Prequel is accurate at
all FF levels and does not require a FF cutoff like other NIPS
offerings. In this study, we showed that Prequel also is
accurate in women at all BMI levels and that tests that are
required to use a FF cutoff may underperform at higher BMIs
compared to both Prequel and non-DNA screens,” said Dr.
Goldberg. “Importantly, Prequel maintained high analytical
sensitivity across all BMIs, meaning more women will receive an
answer the first time they are screened, which may reduce patient
anxiety and prevent the need for costly invasive procedures like
amniocentesis or chorionic villus sampling and a delay in
diagnosis.”
The current BMI study builds on a recently published clinical
outcomes study, which demonstrated that Prequel without a
fetal-fraction threshold achieves high accuracy and 999 out of
every 1,000 women received a result. Importantly, this
earlier study also showed that clinical sensitivity and specificity
levels observed with Prequel were high and comparable to those
reported for the other commercial NIPS offerings that have far
higher test no call rates.
About PrequelTM Prenatal ScreenThe Myriad
Prequel Prenatal Screen is a non-invasive 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 than 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 CDx, 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 more women receiving a correct answer the
first time they are screened; 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) 584-3065
rrogers@myriad.com Investor Contact: Scott Gleason (801) 584-1143
sgleason@myriad.com
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