Crescendo Bioscience, a wholly-owned subsidiary of Myriad Genetics,
Inc. (NASDAQ:MYGN), today announced that new data on the use of
Vectra DA to predict treatment response in patients with rheumatoid
arthritis (RA) are being presented at the American College of
Rheumatology/Association of Rheumatology Health Professionals
(ACR/ARHP) meeting being held Nov. 7-11, 2015 in San Francisco,
Calif. Vectra DA 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 17 scientific
publications.
"Much work has been done over the past decade to develop and
validate Vectra DA, and establish the test as an objective measure
for assessing disease activity in patients with rheumatoid
arthritis," said Elena Hitraya, M.D., Ph.D., chief medical officer,
Crescendo Bioscience. "This year, our collaborators are presenting
data on the role of Vectra DA in predicting response to second-line
therapy. In addition, data will be presented examining Vectra DA's
ability to predict which patients may be able to successfully taper
or withdraw from treatment. These data are important and
deserve further exploration because they have the potential to help
physicians tailor treatment plans for their patients and improve
the use of healthcare resources."
A summary of the highlighted Crescendo Bioscience presentations
at ACR (#ACR15) follows:
Presentations
Title: The multi-biomarker disease activity
score in methotrexate incomplete responders predicts clinical
responses to non-biological vs. biological therapy in early RA.
Authors: K. Hambardzumyan, R. Bolce, S.
Saevarsdottir, K. Forslind, J.A. Karlsson and R.F. van
Vollenhoven. Date: Sunday, Nov. 8, 2015:
9:00 – 11:00 a.m. PT. Location: Poster, Abstract
618.
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 MTX incomplete
responders (MTX-IR). The findings demonstrated that, in patients
with early RA and incomplete response to MTX, the Vectra DA test
predicted the relative efficacy of second-line treatment with
triple therapy versus anti-TNF.
"Predicting response to drug therapy is an important goal for
personalizing treatment for individuals with RA," said Ronald F.
van Vollenhoven, M.D., Ph.D., Department of Medicine, Karolinska
Institute in Stockholm, Sweden and the study's lead
investigator. "In this study, patients with a low Vectra DA
score were more likely to respond to conventional triple therapy
than to anti-TNF therapy. These findings may help facilitate
and improve the development of individualized and cost-effective
treatment plans for patients with RA."
Title: Prediction of disease relapses by
multi-biomarker disease test activity in rheumatoid arthritis
patients tapering DMARD treatment. Authors: J.
Rech, A.J. Hueber, M. Englbrecht, S. Finzel, J. Haschka, B. Manger,
A. Kleyer, M. Reiser, H-P Tony, S. Kleinert, M. Feuchtenberger, M.
Fleck, K. Manger, W. Ochs, M. Schmitt-Haendle, J. Wendler, F.
Schuch, M. Ronneberger, H-M Lorenz, H. Nüßlein, R. Alten, J.
Fogagnolo Cobra, J.C. Henes, K. Krüger and G.A. Schett.
Date: Tuesday, Nov. 10, 2015: 9:00 – 11:00 a.m.
PT. Location: Poster, Abstract: 2584.
This study analyzed the role of Vectra DA in predicting disease
relapse in patients with RA in sustained remission, following the
tapering of treatment with disease modifying anti-rheumatic drugs
(DMARDs). Vectra DA improved the prediction of relapse in RA
patients in stable remission undergoing DMARD
tapering. Additionally, when combined with anti-citrullinated
protein antibody (ACPA) status, Vectra DA resulted in a correct
case classification of relapse in approximately 80 percent of
patients.
Title: Multi-biomarker disease activity score
as a predictor of flare in patients with rheumatoid arthritis who
stop TNF-alpha-inhibitor therapy. Authors: F.
Lamers-Karnebeek, M. Ghiti Moghadam, H.E. Vonkeman, J. Tekstra, A.
Schilder, H. Visser, P.M. ten Klooster, E.H. Sasso, D. Chernoff, W.
Lems, D. van Schaardenburg, R. Landewé, L. Van Albada, T.R.D.J.
Radstake, P. van Riel, M.A.F.J. van de Laar and T. Jansen.
Date: Tuesday, Nov. 10, 2015: 9:00 – 11:00 a.m.
PT. Location: Poster, Abstract: 2594.
This study evaluated the Vectra DA score as a predictor of flare
after discontinuation of treatment with tumor necrosis factor
inhibitor (TNFi). Data were assessed from 439 RA patients who
were randomized to stop TNFi treatment in the Dutch multi-center
POET trial. The Vectra DA score was evaluated in all patients
at baseline. Flare was defined as: 1) re-initiating TNFi
treatment, 2) escalation of any medication, and 3)
physician-reported flare. This study found that a high Vectra
DA score at baseline was an independent predictor of flare within
12 months of discontinuing TNFi therapy.
For more information about these presentations, including a
complete list of abstracts and presentations, please visit the ACR
website at http://acrannualmeeting.org/abstracts/.
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 Bioscience
Crescendo 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
website at www.CrescendoBio.com.
About Myriad Genetics
Myriad 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 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 Vectra DA data to be
presented at the 2015 American College of Rheumatology (ACR) Annual
Meeting, November 7-11, 2015, in San Francisco, Calif.; 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 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.
CONTACT: Media Contact: Ron Rogers
(801) 584-3065
rrogers@myriad.com
Investor Contact: Scott Gleason
(801) 584-1143
sgleason@myriad.com
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