Myriad Advances Proprietary myVision® Variant Classification Tools to a Broader Range of Cancer Risk Genes
March 09 2016 - 7:46PM
Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular
diagnostics and personalized medicine, today announced it will
present new data on its proprietary variant classification program
that is used to classify variants in cancer risk genes. The
study will be highlighted at the American College of Medical
Genetics (ACMG) and Genomics annual clinical genetics meeting in
Tampa, Fla.
“As the world leader in multi-gene panel testing for hereditary
cancer, we have a long track record and commitment to advancing the
science of variant classification,” said Johnathan Lancaster, chief
medical officer, Myriad Genetic Laboratories. “Our goal is to
provide physicians with the highest quality results possible for
every test we perform.”
Myriad’s myVision variant classification program is comprised of
proprietary techniques that allow for the most accurate
classification for hereditary cancer variants including: Pheno®,
M-Co®, InSite™ and LitView™. The Pheno technique is a history
weighting algorithm that could only be developed by Myriad after
sequencing the DNA of more than 400,000 patients.
In this study, the Pheno algorithm was used to analyze variants
of unknown significance associated with high cancer risk genes
including BRCA1, BRCA2, MLH1, MSH2 and MSH6. Additionally,
the algorithm was updated to analyze variants of unknown
significance in moderate cancer risk genes including ATM, CHEK2 and
PALB2. The results of this study showed that Pheno was
>99.5 percent accurate for upgrading and downgrading variants of
uncertain significance to more definitive clinical
classifications.
“As the myRisk Hereditary Cancer 25-gene panel test becomes more
integrated into clinical practice, there will be a need to classify
a greater number of variants,” said Lancaster. “Variants of
uncertain significance are particularly problematic for physicians
because they leave questions as to whether variations in a
patient’s DNA are of concern. This study demonstrates the
ability of Pheno to accurately classify variants from a broader
range of genes, which should help reduce anxiety for more patients
and their families.”
Details about the featured Myriad presentations at ACMG are
below. Follow Myriad on Twitter via @MyriadGenetics and stay
up-to-date with the meeting by using the hashtag #ACMGMtg16.
Myriad Presentations
- Title: Reclassification of uncertain variants
identified in high and moderate cancer risk genes using history
weighting analysis.Date: Friday, March 11, 2016:
10:30 a.m. to 12:00 p.m. ET.Location: Poster
110.Presenter: Karla Bowles, Myriad Genetic
Laboratories.
- Title: Detailed review of four patients
affected with cancer that were previously unaffected at the time of
single syndrome testing and subsequently had pathogenic variants
identified by a 25-gene panel.Date: Thursday,
March 10, 2016: 10:30 a.m. to 12:00 p.m.
ET.Location: Poster
109.Presenter: Allison Anguiano, Myriad Genetic
Laboratories.
About Pheno and myVision Variant Classification
Program
Pheno is a family history-weighting tool that compares the
severity of personal and family histories of patients who carry a
specific variant to that of individuals who carry known deleterious
mutations and to individuals in whom no mutation was
detected. Pheno is a proprietary component of the myVision™
Variant Classifcation Program, which is the most advanced
informatics program in the industry, overseeing the classification
and reclassification of genetic variants, and is part of Myriad’s
commitment to patients and their families that lasts a
lifetime. For more information about Myriad’s variant
classification program visit:
https://www.myriadpro.com/for-your-practice/myvision-2/.
About Myriad myRisk® Hereditary Cancer
Testing
The Myriad myRisk Hereditary Cancer test uses next-generation
sequencing technology to evaluate 25 clinically significant genes
associated with eight hereditary cancer sites including: breast,
colon, ovarian, endometrial, pancreatic, prostate and gastric
cancers and melanoma. For more information visit:
https://www.myriad.com/products-services/hereditary-cancers/myrisk-hereditary-cancer/.
About Myriad Genetics
For more than 25 years, Myriad Genetics Inc., has been 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
three strategic imperatives: transitioning and expanding its
hereditary cancer testing markets, diversifying its product
portfolio through the introduction of new products and increasing
the revenue contribution from international markets. 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, Myriad myRisk, myRisk Hereditary Cancer, myChoice,
myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx, myChoice HRD,
Vectra, Prolaris, Pheno and myVision 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 Statement
This press release contains "forward-looking statements" within
the meaning of the Private Securities Litigation Reform Act of
1995, including statements related to the Company being a leader in
multi-gene panel testing for hereditary cancer; providing
physicians with the highest quality results possible for every test
the Company performs; the ability of Pheno to accurately
upgrade and downgrade variants of uncertain significance;
statements about myRisk Hereditary Cancer 25-gene panel test
becoming more integrated in clinical practice; the ability of Pheno
to accurately classify variants from a broader range of genes,
which should help reduce anxiety for more patients and their
families; 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; 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, 2015, 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
(908) 285-0248
rrogers@myriad.com
Investor Contact:
Scott Gleason
(801) 584-1143
sgleason@myriad.com
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