Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular
diagnostics and personalized medicine, today announced results from
Study 005, a large 2,000 patient prospective study of the Myriad
myRisk® Hereditary Cancer test, which will be featured in three
poster presentations at the 53rd annual meeting of the American
Society of Clinical Oncology (ASCO).
The data will be presented by research collaborators from
University of Southern California (USC) Norris Comprehensive Cancer
Center and Stanford University Cancer Institute. The key
findings are that more than 50 percent of the mutations identified
were in patients who would not meet current testing guidelines and
34 percent of mutations were identified in unexpected genes,
confirming the clinical utility of multi-gene panel testing to
improve hereditary cancer-risk assessment.
“We are very excited to present new data on our myRisk
Hereditary Cancer test which shows our ongoing commitment to
collaborate with leading academic centers and advance the field of
hereditary cancer testing,” said Johnathan Lancaster, M.D.,
Ph.D., chief medical officer, Myriad Genetic
Laboratories. “Importantly this study demonstrates that more
than half of mutations would be missed with current testing
guidelines and 34 percent of mutations identified were unexpected
and not predicted by personal and/or family history. This
study will provide vital data to facilitate review of medical
guidelines in light of advances made in next generation
sequencing.”
The data are highlighted below and abstracts are available at:
abstracts.asco.org. Follow Myriad on Twitter via
@MyriadGenetics and stay informed about symposium news and updates
by using the hashtag #ASCO17.
myRisk Hereditary Cancer Poster Presentations
Title: Performance of Mutation Risk
Prediction Models in a Racially Diverse Multi-Gene Panel Testing
Cohort.Presenter: Gregory Idos, M.D., USC
Norris Comprehensive Cancer Center.Date:
Monday, June 5, 2017, 1:15 – 4:45 p.m.
Location: Poster 181; Abstract 1523
National Comprehensive Cancer Network (NCCN) guidelines
recommend germline genetic testing for patients with a mutation
carrier probability (CP) score of five percent or higher. An
analysis of data from Study 005 evaluated the percentage of
pathogenic mutations in a population of racially diverse patients
with a CP score less than five percent. In total 2,000
patients were tested using the myRisk Hereditary Cancer test and
242 were found to have pathogenic mutations. The results
showed that more than 50 percent of patients with BRCA1/2 or
mismatch repair (MMR) mutations had a CP score less than five
percent. Four percent of patients with BRCA1/2 mutations did
not meet NCCN guidelines for hereditary breast and ovarian cancer
syndrome, and 13 percent of patients with MMR mutations did not
meet NCCN criteria for Lynch syndrome testing. Importantly,
these findings support lowering the guideline-recommended CP
threshold for genetic testing to help ensure that more patients can
access genetic testing.
Title: Yield of multiplex panel testing
exceeds expert opinion and validated prediction
models.Presenter: Gregory Idos, M.D., USC
Norris Comprehensive Cancer Center.Date:
Monday, June 5, 2017, 1:15 – 4:45 p.m.
Location: Poster 183; Abstract 1525.
Data from Study 005 were evaluated to determine the diagnostic
yield and clinical utility of panel testing using the myRisk
Hereditary Cancer 28-gene test in 2,000 patients undergoing
hereditary cancer-risk assessment. Approximately 81 percent
of patients were women and 40 percent were Hispanic.
Differential diagnoses were generated after standard clinical
genetics assessment and before genetic testing. Differences
between the differential diagnoses and genetic testing results were
evaluated to determine the added diagnostic yield of multi-gene
panel testing. The results show that 12.1 percent of patients
tested positive for a pathogenic mutation. The most common
mutations were in BRCA1 (17 percent) and BRCA2 (15 percent), APC (8
percent), CHEK2 (7 percent) and ATM (7 percent). Importantly,
however, 34 percent of the mutations were not clinically suspected
before genetic testing, which demonstrates the significant added
value of the myRisk Hereditary Cancer test in hereditary
cancer-risk assessment.
Title: Yield of multiplex panel testing
exceeds expert opinion and validated prediction
models.Presenter: Allison Kurian, M.D.,
Stanford University Cancer Institute.Date:
Monday, June 5, 2017, 1:15 – 4:45 p.m.
Location: Poster 234; Abstract 1576.
Study 005 also evaluated the safety of gene panel testing among
patients who were undergoing cancer-risk assessment with the myRisk
Hereditary Cancer test. The analysis of 2,000 patients found
that 12.1 percent of patients had pathogenic mutations.
Overall, self-reported preventative surgery rates were low
(mastectomy 9.2 percent, hysterectomy 1.6 percent, and oophorectomy
1.8 percent). There was no difference in preventative surgery
rates between patients with a variant of uncertain significance
(VUS) and mutation negative patients (p=0.21). Importantly,
most patients never/rarely had thoughts of cancer affecting their
daily activities, did not regret genetic testing and wanted to know
all the results. Patients with a pathogenic mutation reported
higher distress and uncertainty scores than VUS or negative
patients, whose distress (p=0.06) and uncertainty (p=0.04) scores
were similar. Relatives of mutation positive patients
completed genetic testing more often than VUS or negative
patients. This study demonstrated that multi-gene panel
testing did not result in inappropriate medical management or
increased distress/uncertainty among VUS and negative patients.
“The use of multi-gene panels for the clinical assessment of
hereditary cancer risk is rapidly increasing in the era of
personalized medicine and it’s important that we understand the
benefits and risks of genetic testing on patients,”
said Lancaster. “Study 005 showed that multi-gene panel
testing effectively improved hereditary cancer risk assessment and
the results did not lead to unwarranted treatment or adverse
effects.”
About Myriad myRisk® Hereditary Cancer The
Myriad myRisk Hereditary Cancer test uses an extensive number of
sophisticated technologies and proprietary algorithms to evaluate
28 clinically significant genes associated with eight hereditary
cancer sites including: breast, colon, ovarian, endometrial,
pancreatic, prostate and gastric cancers and melanoma. The
myRisk Hereditary Cancer test offers physicians several distinct
advantages over other commercial tests, including:
- Unsurpassed lab accuracy:
- 85,000 base pairs with ~100 percent accuracy.
- 856 steps using 23 major technology platforms.
- 100 proprietary software applications.
- Industry leading variant classification:
- More than 20 years of investment in research.
- >2.5 million patients tested; 50,000 variants
identified.
- Five proprietary methods with 99.5 percent validity.
- Exceptional customer service:
- More than 40,000 ordering physicians annually.
- 450 field educators.
- Extensive reimbursement support.
- Lifetime commitment to patients.
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
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, myRisk, Myriad myRisk, myRisk Hereditary Cancer,
myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx,
myChoice HRD, Vectra and Prolaris 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 presentation of data from three clinical studies at
the 2017 American Society of Clinical Oncology annual meeting to be
held June 2-6, 2017 in Chicago, Ill; key podium presentations
highlighting the performance of the myRisk Hereditary multigene
panel test in assessing hereditary cancer risk; the myRisk
Hereditary Cancer studies presented at ASCO advancing the field of
hereditary cancer testing; the new data providing additional
evidence for the safety and efficacy of the myRisk Hereditary
Cancer test to help improve and save the lives of patients; 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, 2016, 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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