Crescendo Bioscience, a wholly-owned subsidiary of Myriad Genetics,
Inc. (NASDAQ:MYGN), today announced that new data on the use of
Vectra® DA test to predict treatment response in patients with
rheumatoid arthritis (RA) are being presented at European League
Against Rheumatism (EULAR) meeting being held June 8-11, 2016, in
London. Vectra DA test is the first and only multi-biomarker
blood test validated to measure disease activity in patients with
RA and has been evaluated in multiple studies, resulting in 23
scientific peer-reviewed publications.
“Our collaborators are presenting three very exciting studies
with Vectra DA test at EULAR. These studies highlight the
utility of Vectra DA test to predict flare and sustained remission
in patients discontinuing treatment, as well as treatment response
to biologic and non-biologic therapies,” said Elena Hitraya, M.D.,
Ph.D., chief medical officer, Crescendo Bioscience. “These results
add to the growing body of data on the use of Vectra DA test to
measure disease activity, individualize treatment plans and achieve
better health outcomes for people with RA.”
A summary of the highlighted Crescendo Bioscience presentations
at EULAR (#EULAR2016) follows:
Poster Presentations
Title: Predictive value of the multi-biomarker
disease activity (MBDA) score for flare and sustained remission in
the HONOR study.Authors: S Hirata, S. Tang, C.C.
Hwang, et al.Date: Friday, June 10, 2016:
11:45 a.m. – 1:30 p.m. Location: Poster
FRI0096.
This study evaluated the predictability of the Vectra DA score
for flare and sustained clinical remission after discontinuation of
adalimumab (ADA) in 42 patients with RA from the HONOR study.
At baseline, 67 percent of patients had a low Vectra DA score and
12 percent had a high Vectra DA score. The results showed
that three out of five patients (60 percent) who had an elevated
Vectra DA score at discontinuation of ADA developed flare within
one year. In parallel, 16 of 28 patients (57 percent) with a
low score at discontinuation had sustained clinical
remission. These findings suggest that the Vectra DA score
can predict flare and sustained remission following ADA
discontinuation in patients with established RA and indicate the
potential utility of Vectra DA for guiding treatment decisions in
patients undergoing a discontinuation or tapering of biologics.
Title: Changes in multi-biomarker disease
activity (MBDA) score correlate with changes in established disease
activity measurements in patients with early RA from the OPERA
study.Authors: C.H. Brahe, M. Ostergaard, J.
Johnsen, et al.Date: Friday, June 10, 2016:
11:45 a.m. – 1:30 p.m. Location: Poster
FRI0067.
This study investigated the correlation between early changes in
the Vectra DA score at 6- and 12-months and established clinical
disease activity measures. A total of 180 treatment-naïve
patients with early RA were randomized to receive MTX or MTX +
adalimumab (ADA). For both treatment groups, statistically
significant correlations were observed between changes in Vectra DA
scores from baseline to 3- or 6-months and clinical measures
including: disease activity score (DAS28), clinical disease
activity index (CDAI), simplified disease activity index (SDAI) and
C-reactive protein (CRP). Importantly, the Vectra DA score
decreased significantly in both treatment arms with the largest
decreases observed between baseline and three months and treatment
responses were highest for patients in the MTX-ADA arm
(P=0.006). The Vectra DA score also was a significant
independent predictor of clinical remission at six months (P=0.05),
and the remission rate at 12 months was higher in patients with a
larger change in Vectra DA score versus those with a smaller change
(80 percent vs. 61 percent; P=0.015). These findings support
the use of Vectra DA to predict treatment response and remission in
patients with early RA.
Title: The multi-biomarker disease activity
score in methotrexate incomplete responders predicts clinical
responses to non-biological versus biological therapy in early
RA.Authors: K. Hambardzumyan, R. Bolce, S.
Saevarsdottir, et al.Date: Saturday, June
11, 2016: 10:15 – 11:00 a.m. Location: Poster
SAT0066.
The objective of this study was to evaluate whether the Vectra
DA score could be used to predict the optimal choice of second-line
treatment for 157 patients with RA who were methotrexate (MTX)
incomplete responders (MTX-IR). The findings demonstrated that, in
patients with early RA and incomplete response to MTX, the Vectra
DA test effectively predicted those who were more likely to respond
to treatment with triple therapy versus anti-TNF
(infliximab). Specifically, patients with a lower Vectra DA
score and/or a larger decrease in the first three months of
treatment with MTX monotherapy were more likely to respond to
triple therapy. In contrast, patients who had a high Vectra
DA score and/or a smaller decrease were more likely to respond to
anti-TNF therapy. Importantly, the Vectra DA score at three months
was a better independent predictor of treatment response at Year 1
than CRP, ESR and DAS28. These results demonstrate that Vectra DA
can be used to guide biologic or non-biologic treatment decisions
for patients with early RA who do not respond to MTX monotherapy in
the first three months.
For more information about these presentations, including a
complete list of abstracts and presentations, please visit the
EULAR website at http://www.congress.eular.org/.
About Vectra® DA Vectra DA is the only
multi-biomarker blood test for rheumatoid arthritis (RA) disease
activity that integrates the concentrations of 12 serum proteins
associated with RA disease activity into a single objective score,
on a scale of 1 to 100, to help physicians make more informed
treatment decisions. Vectra DA testing is performed at the
Crescendo Bioscience state-of-the-art CLIA (Clinical Laboratory
Improvement Amendments) facility. Test results are reported to the
physician 5 to 7 days from shipping of the specimen to Crescendo
Bioscience. Physicians can receive test results via standard mail,
by fax or via the private web portal, VectraView. For more
information on Vectra DA, please visit: www.Vectra-DA.com.
About Crescendo BioscienceCrescendo Bioscience,
a wholly-owned subsidiary of Myriad Genetics, Inc., is a molecular
diagnostics company dedicated to developing and commercializing
quantitative blood tests for rheumatoid arthritis (RA) and other
autoimmune diseases, located in South San Francisco, Calif.
Crescendo Bioscience develops quantitative, objective, reproducible
blood tests to provide rheumatologists with deeper clinical insight
to help enable more effective management of patients with
autoimmune and inflammatory diseases. For more information,
please visit the Company’s website at www.CrescendoBio.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, 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 Vectra DA data to be presented at the
European League Against Rheumatism (EULAR) meeting being held June
8-11, 2016, in London; the Company’s commitment to understanding
the molecular underpinnings of rheumatoid arthritis and autoimmune
disorders; the ability of Vectra DA to predict or assess treatment
response in patients with rheumatoid arthritis; 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
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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
(801) 584-3065
rrogers@myriad.com
Investor Contact:
Scott Gleason
(801) 584-1143
sgleason@myriad.com
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