Myriad Genetics, Inc. (NASDAQ: MYGN), a global leader in
personalized medicine, today announced that its Myriad Women’s
Health business unit will present results from two important
studies at the 2019 American College of Medical Genetics and
Genomics (ACMG) Annual Clinical Genetics Meeting that highlight the
performance of its prenatal tests. The key findings are that
the Foresight® Carrier Screen identifies 45 percent more couples at
risk for having a child with cystic fibrosis than current
guideline-based testing, and that the Prequel™ Prenatal Screen
provides reliable results to 99.9 percent of patients spanning the
entire spectrum of fetal-fraction levels.
“Our studies demonstrate the outstanding clinical performance of
our tests in a general population of patients undergoing carrier
and prenatal screening,” said James Goldberg, M.D., board certified
maternal fetal medicine specialist, medical geneticist and chief
medical officer, Myriad Women’s Health. “We believe these
data will help inform medical guideline updates, support decision
making and lead to better outcomes for couples.”
The key data are summarized below. Please visit Myriad
Women’s Health at booth #1218 to learn more about our leading
portfolio of women’s health products. Follow Myriad on
Twitter via @myriadgenetics and @MyrWomensHealth and keep up to
date with meeting news and updates by using the hashtag
#ACMGMtg19.
Foresight Carrier Screen
Title: Sequencing as a First-Line
Methodology for Cystic Fibrosis Carrier
ScreeningPresenter: Dale Muzzey, Ph.D.,
Myriad Women’s Health.Date: Friday, April 5,
2019, 10:30 a.m. to 12:00 p.m. Location:
Poster 880
This study evaluated the performance of sequencing-based cystic
fibrosis (CF) screening using the Foresight Carrier Screen compared
to genotyping. Three carrier screening strategies were
evaluated: 1. Genotyping 23 guideline-recommended genetic
variants (CF23); 2. Sequencing all coding bases in the CFTR
gene (NGS) using Foresight; and 3. Sequencing plus large
copy-number variant identification (NGS+CNV) also using Foresight.
The results show that among the 13,080 couples screened, 58 were
determined to be couples at risk for a pregnancy affected by CF: 40
were detected by CF23-only screening, 17 additional couples by NGS,
and one couple by NGS+CNV. Importantly, these findings
demonstrate that using Foresight would increase the detection of
at-risk couples by 45 percent relative to current guideline-based
testing. Of the couples at risk for CF who were identified,
89 percent said they planned or pursued actions to reduce the risk
of having a pregnancy affected by CF, which underscores the
clinical utility of the Foresight Carrier Screen to provide
actionable information to prospective parents.
“Current medical guidelines for cystic fibrosis recommend
carrier screening via targeted genotyping of 23 frequent variants
but that approach may miss many couples at risk,” said
Goldberg. “Our findings suggest the CF guidelines should be
updated to allow for modern NGS and variant interpretation that
will enable more effective screening and better detection of
at-risk couples.”
Prequel Prenatal Screen
Title: Avoiding Unnecessary Trade-Offs:
Clinical Experience for a Noninvasive Prenatal Screen with Both Low
Test Failure Rate and High
AccuracyPresenter: Susan Hancock, CGC,
Myriad Women’s Health.Date: Thursday, April
4, 2019, 10:00 a.m. to 11:00 a.m. Location:
Poster 911
This study retrospectively analyzed data from 58,105 women
screened with the Prequel Prenatal Screen, which uses a whole
genome sequencing approach to noninvasive prenatal screening
(NIPS). Importantly, while Prequel measures fetal fraction,
samples are not routinely failed due to fetal fraction being below
a predetermined threshold. The results demonstrate that
Prequel provided a test result for 99.9 percent of patients,
meaning that only one in 1,000 received no result. In the
cohort, a total of 572 cases tested positive for an aneuploidy or
suspected aneuploidy and the clinical sensitivity and specificity
levels were comparable to those observed for NIPS offerings with
much higher failure rates. Critically, the study shows that
performance would not be improved with the use of a fetal-fraction
threshold. Rather, applying such a threshold to Prequel would
serve only to cause thousands of women to receive a test failure
and would unnecessarily delay the identification of a number of
affected pregnancies.
“What this data demonstrates is the high accuracy of the Prequel
test below a fetal fraction of four percent, meaning more patients
receive reliable results the first time,” said Goldberg. “We
believe the ability of the Prequel test to perform at any
fetal-fraction level is unprecedented and makes it the most
effective noninvasive prenatal screening test for aneuploidy
available to clinicians today.”
About Foresight® Carrier ScreenThe Myriad
Foresight Carrier Screen is designed to maximize detection of
at-risk couples for serious, prevalent, and clinically-actionable
conditions. Foresight has a rigorous disease selection that focuses
on 175+ conditions that provides meaningful information to
patients. Additionally, Foresight offers superior technology with
unmatched detection rates for the vast majority of genes on the
panel (>99% across ethnicities) which means patients can trust
both positive and negative results.
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, 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, 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 Company’s presentation of new data for
its expanded carrier and noninvasive prenatal screens being
featured at the 2019 Annual Clinical Genetics Meeting April 2-6,
2019 in Seattle; the studies demonstrating the outstanding clinical
performance of our tests in a general population of patients
undergoing carrier and prenatal screening; the Company’s belief
that this data will help inform medical guideline updates, support
decision making and lead to better outcomes for couples; the
possibility that current medical guidelines for cystic fibrosis
recommending carrier screening via targeted genotyping of 23
frequent variants may miss many couples at risk; the suggestion
that CF guidelines should be updated to allow for modern NGS and
variant interpretation that to enable more effective screening and
better detection of at-risk couples; this data demonstrating the
high accuracy of the Prequel test below a fetal fraction of four
percent, meaning more patients receive reliable results the first
time; the Company’s belief that the ability of the Prequel test to
perform at any fetal-fraction level is unprecedented and makes it
the most effective noninvasive prenatal screening test for
aneuploidy available to clinicians today; 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: |
Ron Rogers |
|
Investor Contact: |
Scott Gleason |
|
(801) 584-3065 |
|
|
(801) 584-1143 |
|
rrogers@myriad.com |
|
|
sgleason@myriad.com |
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