Myriad Announces Publication of Expanded Carrier Screen Study in Genetics in Medicine
March 06 2019 - 7:05AM
Myriad Genetics, Inc. (NASDAQ: MYGN), a global leader in
personalized medicine, today announced that its Myriad Women’s
Health business unit has published the first data-driven evaluation
of commonly stated recommendations of panel inclusion criteria for
expanded carrier screening (ECS) in the journal Genetics in
Medicine. The key finding is that the interpretation of
current criteria are ambiguous and should be clarified such that
ECS can more broadly identify couples at increased risk of passing
on serious inherited genetic conditions to their children.
In an analysis of more than 55,000 patients tested with the
Foresight®️ 176-condition ECS panel, the study identified how many
carriers and at-risk couples would have been missed if the panel
were constructed using different interpretations of existing
professional organization criteria. For instance, one
criterion states that screened conditions should have a carrier
rate of at least 1-in-100, yet it is not clear whether this
threshold applies to X-linked conditions or whether it must be
exceeded in any ethnicity or in all ethnicities. The study
showed that these distinctions are clinically consequential because
depending on the definition used, a compliant panel identifies
between 11 percent (3 conditions) and 89 percent (38 conditions) of
at-risk couples relative to the Foresight 176-condition
panel. With the most restrictive interpretation – where the
carrier rate threshold must be exceeded in all ethnicities – common
conditions like cystic fibrosis would be omitted from ECS.
Clarifying the current guidelines to include a 1-in-100 carrier
rate for any ethnicity results in a 38-condition panel that
identifies 89 percent of at-risk couples.
“Existing professional opinions can be interpreted in many ways,
which can create confusion and limit the identification of couples
at risk for pregnancies affected with serious conditions,” said
James Goldberg, M.D., board certified maternal fetal medicine
specialist, medical geneticist and chief medical officer, Myriad
Women’s Health. “Our study provides data that will be helpful
to professional organizations as they update their guidelines to
enable screening of many conditions in a clinically responsible
manner, with the goal of maximizing the clinical utility of ECS for
prospective parents.”
About Foresight® The
Foresight Carrier Screen is a genetic test that identifies couples
who are at increased risk of passing on inherited conditions to
their children. Foresight tests for more than 175 serious and
clinically-actionable conditions. It is estimated that serious
genetic conditions affect one in 300 pregnancies.
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 announced results from a data-driven
evaluation of commonly stated recommendations of panel inclusion
criteria for expanded carrier screening (ECS) published in the
journal Genetics in Medicine; the key finding that current criteria
are unclear and should be updated such that ECS can more broadly
identify couples at increased risk of passing on serious inherited
genetic conditions to their children; the study
providing data that will be helpful to professional organizations
as they update their guidelines to enable screening of many
conditions in a clinically responsible manner, with the goal of
maximizing the clinical utility of ECS for prospective
parents; 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 |
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sgleason@myriad.com |
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