Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in molecular
diagnostics and precision medicine, announced that results of a new
validation study of the company’s polygenic risk score (PRS) for
breast cancer were presented at the 2019 San Antonio Breast Cancer
Symposium (SABCS) in San Antonio, Tx. The key finding is that
the PRS significantly improves the precision and accuracy of breast
cancer risk estimates for women of European ancestry who have
pathogenic variants (PV) in high- and moderate-penetrance breast
cancer genes.
“Our goal is to help women understand their risk of breast
cancer so that they can take steps to live longer, healthier
lives. Women who have a family history of breast cancer
should consider hereditary cancer testing with the myRisk
Hereditary Cancer test,” said Jerry Lanchbury, Ph.D., chief
scientific officer of Myriad Genetics. “In this landmark
study, we demonstrated that for women who test positive for a
mutation in one of the five most common breast cancer genes, there
are additional genetic factors called single nucleotide
polymorphisms (SNPs) that can further influence their lifetime risk
of breast cancer.”
A summary of the study follows below. Follow Myriad on
Twitter via @myriadgenetics and keep up to date with SABCS meeting
news and updates by using the #SACBS19 hashtag.
Myriad Poster Presentation
Title: Polygenic Breast Cancer Risk
Modification in Carriers of High and Intermediate Risk Gene
Mutations.Presenter: Elisha Hughes,
Ph.D.Date: Saturday, Dec. 14, 2019,
7:00–9:00 a.m. Location: Poster P6-08-07
This validation study evaluated the 86-SNP PRS as a breast
cancer risk factor for women who carry PV in the BRCA1, BRCA2,
CHEK2, ATM and PALB2 genes and for PV-free women. The
analysis included data from 152,012 women of European ancestry who
received a myRisk® Hereditary Cancer test as part of their clinical
hereditary cancer risk assessment. The results demonstrated
that the 86-SNP PRS significantly modified the breast cancer risk
for women with pathogenic mutations in the five tested breast
cancer genes (p-value <10-4). For some women, the PRS
significantly increased the gene-based risk of breast cancer, while
in others the gene-based risk was reduced (see Graph 1).
Importantly, the greatest PRS risk-modification was observed in
carriers of CHEK2, ATM and PALB2 mutations with some women reaching
the risk levels associated with BRCA1 and BRCA2 mutations.
To view Graph 1: PRS Significantly Modifies
Lifetime Breast Cancer Risk in Mutation Carriers, please
visit the following
link: https://www.globenewswire.com/NewsRoom/AttachmentNg/d56c93ca-e00f-452d-b051-6325a578454c
“These findings mean that we have the potential to significantly
improve the precision of hereditary cancer risk assessment for
women who test positive for mutations in the high and intermediate
risk breast cancer genes,” said Elisha Hughes, Ph.D., lead
investigator and director of Bioinformatics at Myriad
Genetics. “We are optimistic that this additional genetic
information can help clinicians more accurately predict the risk of
breast cancer and provide the best care for their patients in the
future.”
Next StepsThe company plans to publish these
new data in a peer reviewed medical journal and make the PRS
available for U.S. women of European ancestry who test positive for
mutations in breast cancer genes. The PRS currently is
available as part of myRisk® Hereditary Cancer enhanced with
riskScore® for women of European ancestry who test negative for
pathogenic mutations in the breast cancer genes.
Specifically, the riskScore® test combines the PRS with the
Tyrer-Cuzick model to estimate a woman’s 5-year and lifetime risk
for developing breast cancer. The company is committed to
making myRisk® Hereditary Cancer enhanced with riskScore® available
to all ethnicities and is developing the test for women of Hispanic
and African-American ancestry who test negative. The company
is currently conducting the largest ever PRS study in African
Americans and will present the data at a future meeting.
Please visit Myriad at booth #113 to learn more about our
portfolio of genetic tests for breast cancer. Follow Myriad on
Twitter via @myriadgenetics and keep up to date with Symposium news
by using the hashtag #SABCS19.
About riskScore®riskScore
is a new clinically validated personalized medicine tool that
enhances Myriad’s myRisk® Hereditary Cancer test. riskScore
helps to further predict a women’s lifetime risk of developing
breast cancer using clinical risk factors and genetic-markers
throughout the genome. The test incorporates data from more than 80
single nucleotide polymorphisms identified through 20 years of
genome wide association studies in breast cancer and was validated
in our laboratory to predict breast cancer risk in women of
European descent. This data is then combined with a best-in-class
family and personal history algorithm, the Tyrer-Cuzick model, to
provide every patient with individualized breast cancer risk.
About Myriad myRisk® Hereditary CancerThe
Myriad myRisk Hereditary Cancer test uses an extensive number of
sophisticated technologies and proprietary algorithms to evaluate
35 clinically significant genes associated with eight hereditary
cancer sites including: breast, colon, ovarian, endometrial,
pancreatic, prostate and gastric cancers and melanoma.
About Myriad GeneticsMyriad
Genetics Inc. is a leading precision 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 critical success
factors: building 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 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 the Company’s polygenic risk score and data
being featured at the 2019 San Antonio Breast Cancer Symposium
being held Dec. 10-14, 2019 in San Antonio, Tx.; the potential to
significantly improve the precision of hereditary cancer risk
assessment for women who test positive for mutations in the high
and intermediate risk breast cancer genes; this additional genetic
information helping clinicians more accurately predict the risk of
breast cancer and provide the best care for their patients in the
future; publishing these new data in a peer reviewed medical
journal and making the PRS available for U.S. women of European
ancestry who test positive for mutations in breast cancer genes;
making myRisk® Hereditary Cancer enhanced with riskScore® available
to all ethnicities and developing the test for women of Hispanic
and African-American ancestry who test negative; conducting the
largest ever PRS study in African Americans and presenting the data
at a future meeting; 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: |
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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 |
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