Crescendo Bioscience's Vectra(R) DA Predicts Radiographic Progression in Patients With Early Rheumatoid Arthritis
May 14 2014 - 7:05AM
Crescendo Bioscience, a wholly-owned subsidiary of Myriad Genetics,
Inc. (Nasdaq:MYGN), today announced the online publication of a new
study in the journal Annals of the Rheumatic Diseases for
Crescendo's Vectra DA blood test. The study is a retrospective
analysis of data from the Swedish Farmacotherapy (SWEFOT) clinical
trial and shows that Vectra DA is a strong predictor of
radiographically visible damage to joints, known as disease
progression, in patients newly diagnosed with rheumatoid arthritis
(RA). Vectra DA is the only multi-biomarker blood test validated to
assess disease activity in patients with rheumatoid arthritis.
This study evaluated the Vectra DA test score as a predictor of
one-year radiographic progression in 235 patients in SWEFOT. All
patients had early rheumatoid arthritis and had not been previously
treated with a disease-modifying anti-rheumatic drug (DMARD). The
results showed that the Vectra DA score at baseline was an
independent predictor of radiographic progression over one year of
DMARD treatment. Among the 201 patients with a high Vectra DA score
at baseline, 21 percent had radiographic progression at one year.
By contrast, of the 34 patients with a low/moderate Vectra DA
score, only 3.4 percent had radiographic progression at one year,
confirming that patients who do not have a high score are at low
risk of progression. Vectra DA also effectively differentiated
patients with and without disease progression better than the
C-reactive protein (CRP) test, and other traditional measures of
disease activity, including DAS28-CRP. These findings underscore
the clinical value of Vectra DA for predicting disease progression
in newly diagnosed patients with RA and its potential to help
doctors manage patients based on their risk of disease progression.
Importantly, these findings build on earlier results from the
Leiden Early Arthritis Cohort study published in Rheumatology
(Oxford), which showed that patients with a high Vectra DA score
were at a six-fold higher risk of disease progression than those
with a low Vectra DA score.
"Our study demonstrates that Vectra DA provides highly relevant
clinical information in patients with newly diagnosed rheumatoid
arthritis," said Ronald F. van Vollenhoven, M.D., Ph.D, Department
of Medicine, Karolinska University Hospital in Stockholm, Sweden.
"With this test taken before anti-rheumatic therapies are started,
the clinician will have more knowledge about the patient's
prognosis to help inform decisions regarding treatment, an
important step toward personalized medicine in the treatment of
this important musculoskeletal disease."
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, California. Crescendo Bioscience develops
quantitative, objective, 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 Genetics
Myriad Genetics is a leading molecular diagnostic company
dedicated to making a difference in patients' lives through the
discovery and commercialization of transformative tests to assess a
person's risk of developing disease, guide treatment decisions and
assess risk of disease progression and recurrence. Myriad's
molecular diagnostic tests are based on an understanding of the
role genes play in human disease and were developed with a
commitment to improving an individual's decision making process for
monitoring and treating disease. Myriad is focused on strategic
directives to introduce new products, including companion
diagnostics, as well as expanding internationally. For more
information on how Myriad is making a difference, please visit the
Company's website: www.myriad.com.
Myriad, the Myriad logo, Prolaris, Myriad myPath, Myriad myPlan,
Myriad myRisk, and Vectra are trademarks or registered trademarks
of Myriad Genetics, Inc. 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 relating to the Vectra DA clinical study
data; the significant clinical value of Vectra DA
which may help doctors manage patients based on their risk of
disease progression; the effectiveness of Vectra DA testing to
accurately predict disease progression in patients newly diagnosed
with rheumatoid arthritis (RA); and the Company's strategic
directives under the captions "About Vectra DA," "About Crescendo
Bioscience" and "About Myriad Genetics." These "forward-looking
statements" are management's present 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 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 companion diagnostic
services may decline or will not continue to increase at historical
rates; risks related to changes in the governmental or private
insurers reimbursement levels for our tests; the risk that we may
be unable to develop or achieve commercial success for additional
molecular diagnostic tests and companion diagnostic services in a
timely manner, or at all; the risk that we may not successfully
develop new markets for our molecular diagnostic tests and
companion diagnostic 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 companion diagnostic 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; risks related to increased competition and the
development of new competing tests 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; risks related to changes in intellectual
property laws covering our molecular diagnostic tests and companion
diagnostic 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 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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