Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular
diagnostics and personalized medicine, today announced results of a
large head-to-head study comparing the efficacy of six tests used
to predict the recurrence of breast cancer. A key finding was
that EndoPredict® (EPclin), a second-generation test, was superior
to Oncotype Dx™ (RS), a first-generation test, in predicting the
long-term recurrence of breast cancer. The results are being
featured today in a podium presentation at the 2016 San Antonio
Breast Cancer Symposium (SABCS) in San Antonio, Texas.
“In this important study, EndoPredict more accurately predicted
the risk of breast cancer recurrence than the first-generation
Oncotype Dx test, particularly in years five to 10 following
surgery when half of breast cancer recurrences will happen,” said
Johnathan Lancaster, M.D., Ph.D., chief medical officer, Myriad
Genetic Laboratories. “Clinicians can consider using EndoPredict to
identify patients who can forgo chemotherapy with confidence,
knowing they have a low risk of recurrence over 10
years.”
Podium PresentationTitle:
Comprehensive comparison of prognostic signatures for breast cancer
in TransATAC.Presenter: Ivana Sestak,
Ph.D.Date: Friday, Dec.9, 2016: 4:15 p.m.
CT.Location: S6-05; General Session 6 - Hall
3.
This study was led by scientists at the Institute of Cancer
Research in London. The analysis included 818 women with
ER+/HER2- breast cancer (591 node-negative; 227 node-positive) from
the TransATAC study and compared the power of six predictive
signatures, including: clinical treatment score,
immunohistochemical markers, Oncotype Dx recurrence score (RS),
breast cancer index (BCI), Prosigna™ and EndoPredict
(EPClin). Distant recurrence of breast cancer was the primary
endpoint and the median follow-up period was 10 years.
Overall, each of the three second-generation tests evaluated
(breast cancer index, Prosigna and EndoPredict) outperformed
Oncotype Dx in this cohort in predicting the recurrence of breast
cancer in both node-negative and node-positive patients across both
zero to 10 and five to 10 years post-surgery. In a
head-to-head comparison between EndoPredict and Oncotype Dx in this
study:
- EndoPredict offered more predictive power than Oncotype
Dx across zero to 10 years.
- The data show that the likelihood ratio (LRx2, a common measure
of predictive power) for EndoPredict was almost double that of
Oncotype Dx in node-negative patients (EndoPredict: LRX2= 40.6;
Oncotype: LRX2=22.8) and was five times higher in node-positive
patients (EndoPredict: LRX2= 35.6; Oncotype: LRX2=6.4).
- EndoPredict had superior predictive power over Oncotype
Dx between five to 10 years.
- The likelihood ratio for EndoPredict was seven times higher
than for Oncotype Dx in node-negative patients (EndoPredict: LRX2=
24.0; Oncotype: LRX2=3.4) and 13 times higher in node-positive
patients (EndoPredict: LRX2= 14.9; Oncotype: LRX2=1.1).
Importantly, the likelihood ratio for Oncotype DX failed to achieve
statistical significance in predicting cancer recurrence in years
five to 10 for either node-positive or node-negative patients,
indicating an inability to predict distant recurrence over the five
to 10 year timeframe.
- EndoPredict was superior in classifying node-positive
patients as low-risk compared to Oncotype
Dx.
- Node-positive patients classified as low risk by EndoPredict
had a substantially lower 10-year recurrence rate (5.6 percent)
than patients classified as low risk by Oncotype Dx (26.2 percent)
as well as a lower five to 10 year recurrence rate (3.3 percent for
EndoPredict vs 17.9 percent for Oncotype Dx).
"Myriad is committed to research that improves care for patients
with breast cancer. Patients at high risk of cancer
recurrence are candidates for adjuvant chemotherapy after surgery,
while those at low risk can be spared chemotherapy and the side
effects," said Lancaster. "We believe EndoPredict will help
clinicians and patients understand the risk of breast cancer
recurrence and identify more patients who can safely forgo
chemotherapy. Additionally, EndoPredict does not contain an
intermediate risk category and each patient receives a clear test
result, allowing oncologists to confidently develop their treatment
plan.”
The TransATAC study, in part, was previously published in the
Journal of the National Cancer Institute
(http://jnci.oxfordjournals.org/content/108/11/djw149.abstract).
The current presentation at SABCS expands on that article and
provides a comprehensive comparison of prognostic signatures for
breast cancer. Follow Myriad on Twitter via @MyriadGenetics
and stay informed about symposium news and updates by using the
hashtag #SABCS16.
About EndoPredictEndoPredict is a
second-generation, multigene test designed to predict disease
recurrence in patients diagnosed with breast cancer. The test
provides physicians with information to devise personalized
treatment plans for their patients. EndoPredict has been
validated in approximately 4,000 patients with node-negative and
node-positive cancer and has been used clinically in over 13,000
patients. In contrast to the first-generation multigene
prognostic test (i.e., Oncotype Dx), EndoPredict detects the
likelihood of late metastases (i.e., metastasis formation after
more than five years) and, therefore, can guide treatment decisions
regarding the need for chemotherapy, as well as extended
anti-hormonal therapy. Accordingly, therapy decisions backed by
EndoPredict confer a high level of diagnostic safety. For more
information, please visit: www.endopredictusa.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: https://www.myriad.com/.
Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris
AP, myPath, myRisk, myRisk Hereditary Cancer, myChoice, myPlan,
BRACAnalysis CDx, Tumor BRACAnalysis CDx, myChoice HRD, Vectra,
Prolaris, EndoPredict and GeneSight 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
Note to EditorsProsigna is a trademark of
NanoString Technologies, Seattle, Wash. Oncotype Dx is a
trademark of Genomic Health, Redwood City,
Calif.
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 EndoPredict test significantly outperforming the
first-generation test in predicting the risk of node-negative and
node-positive breast cancer recurrence; the EndoPredict test being
superior to Oncotype Dx and more accurate in predicting the
long-term recurrence of breast cancer; the three second-generation
tests evaluated outperforming Oncotype Dx in predicting the
recurrence of breast cancer in both node-negative and node-positive
patients across both zero to 10 and five to 10 years
post-surgery; EndoPredict testing offering more predictive power
than Oncotype Dx across zero to 10 years; EndoPredict testing
having superior predictive power over Oncotype Dx between five to
10 years; EndoPredict testing being superior in classifying
node-positive patients as low-risk compared to Oncotype Dx; our
belief that EndoPredict testing will help clinicians and patients
understand the risk of breast cancer recurrence and identify more
patients who can safely forgo chemotherapy; data being presented at
the 2016 San Antonio Breast Cancer Symposium being held Dec. 6 –
Dec. 10, 2016 in San Antonio, Texas; and the Company's strategic
directives under the captions “About EndoPredict” and "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 described or
implied in the forward-looking statements. These risks include, but
are not limited to: the risk that sales and profit margins of our
existing molecular diagnostic tests and pharmaceutical and clinical
services may decline or will not continue to increase at historical
rates; risks related to our ability to transition from our existing
product portfolio to our new tests; risks related to changes in the
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 tests and any future tests are terminated or
cannot be maintained on satisfactory terms; risks related to delays
or other problems with operating our laboratory testing facilities;
risks related to public concern over our 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, including but not limited to our acquisition of Assurex,
Sividon and the Clinic; risks related to our projections about the
potential market opportunity for our products; 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; 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 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.
Media Contact:
Ron Rogers
(908) 285-0248
rrogers@myriad.com
Investor Contact:
Scott Gleason
(801) 584-1143
sgleason@myriad.com
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