Myriad to Present Three New Studies at the AUA Annual Meeting
May 06 2016 - 7:05AM
Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular
diagnostics and personalized medicine, today announced that results
from three studies will be featured at the American Urological
Association annual meeting, which will take place May 6-10 in San
Diego, Calif. Poster discussions include new data for the
Prolaris
® test in patients with low-risk prostate
cancer, as well as investigational molecular diagnostic tests for
renal and bladder cancer.
“Prolaris is the leading prognostic genetic test for patients
with prostate cancer and is the only such test that predicts the
10-year risk of real oncologic outcomes including death, metastases
and recurrence. The evidence in favor of genetic testing is
expanding, and we’re excited to present a new analysis at AUA that
further confirms the strong prognostic power of Prolaris in men
with low-risk localized prostate cancer,” said Michael Brawer,
senior vice president of Medical Affairs, Myriad Genetic
Laboratories. “We also are presenting new data for our
investigational renal and bladder cancer tests, which further
underscore Myriad’s commitment to developing pioneering molecular
diagnostic tests for other urologic diseases.”
Results of the studies to be presented are described below and
abstracts are now available at: www.aua2016.org/abstracts/.
Follow Myriad on Twitter via @MyriadGenetics to stay informed about
news and updates from the Company.
Highlighted Presentations
- Title: The CCP score provides significant
prognostic information in Gleason score <6
patients.Date: Friday, May 6, 2016: 8:00–10:00
a.m. PT.Location: Poster
MP2.Presenter: Jay Bishoff, M.D., Intermountain
Urological Institute.
This meta-analysis of five studies evaluated the ability of the
Prolaris test (CCP score) to predict oncologic outcomes (i.e.,
recurrence or death) in 440 patients with low-risk localized
prostate cancer, which was defined as a Gleason score of 6 or
less. The results showed that the Prolaris test is a
significant predictor of oncologic outcomes in patients with
low-risk disease (HR 1.5; p<0.009). Prolaris also was a
better independent predictor of outcomes than traditional clinical
features as measured by CAPRA (Cancer of the Prostate Risk
Assessment; HR 1.27; p<0.03). When the Prolaris and CAPRA
scores were assessed together, the combined clinical risk (CCR)
score provided even greater predictive power (HR 1.83;
p<0.0014). In this study, Prolaris was a strong predictor
of the 10-year risk of oncologic outcomes in patients with
localized prostate cancer and a Gleason score of 6 or less.
- Title: A study to evaluate the prognostic and
predictive utility of CCP and HRD assays and genetic sequencing in
patients undergoing neoadjuvant chemotherapy in bladder
cancer.Date: Sunday, May 8, 2016: 1:00–3:00 p.m.
PT.Location: Poster
MP49.Presenter: Hristos Kaimakliotis, M.D.,
Indiana University.
This exploratory study evaluated three molecular assays to
determine if they were able to predict response to neoadjuvant
chemotherapy with cisplatin in patients with urothelial bladder
cancer (UBC). The assays included 1) a cell cycle progression
score, 2) the homologous recombination deficiency (HRD) score, and
3) genetic sequencing of a set of 80 genes associated with UBC. The
results showed that RB1 mutations were associated with response to
cisplatin neoadjuvant chemotherapy, and the predictive ability was
improved by the addition of either the CCP or HRD scores.
Additionally, HRD could be used to predict risk of disease
recurrence in patients after neoadjuvant chemotherapy followed by
cystectomy. If validated, these tests may help identify
chemo-responsive patients.
- Title: Prognostic utility of a multi-gene
signature (the cell cycle proliferation score) in patients with
renal cell carcinoma (RCC) after radical
nephrectomy.Date: Monday, May 9, 2016: 3:30–5:30
p.m. PT.Location: Poster
MP78.Presenter: Adam Feldman, M.D., Massachusetts
General Hospital.
The objective of this study was to assess the ability of the
Myriad myPlan® Renal Cancer cell cycle progression
test to predict long-term oncologic outcomes in patients with
surgically-resected renal cell carcinoma (RCC). Outcomes were
defined as disease recurrence (local or metastatic) or
disease-specific survival (DSS). Patient data were censored
at five-years of follow-up. In the training cohort (N= 305), the
myPlan Renal Cancer test was a significant prognostic predictor for
recurrence (HR: 1.74; p = 0.02) and DSS (HR: 2.59; p< 0.001)
after adjusting for clinical variables. The validation cohort
(N=262) demonstrated a consistent and significant prediction of
recurrence and DSS, with the strongest association being for DSS
(HR: 2.2; p < 0.001) after adjusting for clinical variables.
Based on these data, the myPlan Renal Cancer test appears to be a
significant and independent predictor of key long-term oncologic
outcomes in patients who have undergone nephrectomy for RCC,
providing prognostic information beyond what is available from
clinical parameters. Additional studies are underway to
evaluate the utility of the score when derived from diagnostic
biopsy.
About Prolaris® Prolaris is a
novel 46-gene RNA-expression test that directly measures tumor cell
growth characteristics for stratifying the risk of disease-specific
mortality in patients with prostate cancer. Prolaris provides a
quantitative measure of the RNA expression levels of genes involved
in the progression of tumor growth. Low gene expression is
associated with a low risk of disease-specific mortality in men who
may be candidates for active surveillance and high gene expression
is associated with a higher risk of disease-specific mortality in
patients who may benefit from additional therapy. For more
information visit: www.prolaris.com.
About myChoice® HRDMyriad's
myChoice HRD is the first homologous recombination deficiency test
that can detect when a tumor has lost the ability to repair
double-stranded DNA breaks, resulting in increased susceptibility
to DNA-damaging drugs such as platinum drugs or PARP inhibitors.
High myChoice HRD scores reflective of DNA repair deficiencies are
prevalent in all breast cancer subtypes, ovarian and most other
major cancers. In previously published data, Myriad showed
that the myChoice HRD test predicted drug response to platinum
therapy in certain patients with triple-negative breast and ovarian
cancers. It is estimated that 1.8 million people in the
United States and Europe who are diagnosed with cancers annually
may be candidates for treatment with DNA-damaging agents. For
more information visit: www.myriad.com.
About Myriad myPlan® Renal
CancerMyriad myPlan Renal Cancer is a molecular prognostic
test that measures the expression levels of cell cycle progression
genes to provide an accurate assessment of cancer aggressiveness in
patients with renal cell carcinoma. For more information
visit: https://www.myriad.com/.
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 strong prognostic power of Prolaris testing to
predict 10-year oncologic outcomes in patients with low-risk
localized prostate cancer; the presentation of new data for the
Company’s investigational renal and bladder cancer tests and the
Company’s commitment to developing pioneering molecular diagnostic
tests for other urologic diseases; the study results and suggested
testing utility in each of the three announced studies; 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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