Crescendo Bioscience, a wholly-owned subsidiary of Myriad Genetics,
Inc. (NASDAQ:MYGN), today announced that new data from a
meta-analysis of clinical studies and a registry demonstrating the
ability of the Vectra® DA test to predict joint damage were
presented at the European League Against Rheumatism (EULAR) meeting
in Madrid, Spain.
The key finding is that high Vectra DA score is associated with
significantly increased risk of joint damage progression in a
variety of patients with rheumatoid arthritis (RA), including those
treated with disease-modifying antirheumatic drugs (DMARDs),
tumor necrosis factor-alpha inhibitors (TNFi) and abatacept.
“We are very excited to present a meta-analysis data from over
800 patients tested with the Vectra DA test, which shows our
ongoing commitment to collaborate with academic researchers to
advance the knowledge of Vectra DA and its utility in the
management of rheumatoid arthritis,” said Elena Hitraya, M.D.,
Ph.D., chief medical officer, Crescendo Bioscience.
“Importantly, this analysis confirms the consistency and robustness
of the previous findings. This new information advances the
understanding of the role of molecule biomarkers in RA and can help
to facilitate the discussion on the role of biomarkers in RA
treatment guidance.”
The data are highlighted below and the abstract is available
online at: www.congress.eular.org/abstract_archive.cfm.
Follow Vectra DA on Twitter via @VectraDA and Myriad via
@MyriadGenetics to stay informed about meeting news and updates by
using the hashtag #EULAR2017.
Vectra DA Poster
PresentationTitle: High
multi-biomarker disease activity score is associated with high risk
of radiographic progression in six
studies.Presenter: Eric Sasso, M.D.,
Crescendo Bioscience.Date: Thursday, June
15, 2017, 11:45–1:30 p.m. CEST.Location:
Poster THU0091.
The analysis evaluated data from six cohorts to establish the
relationship between the Vectra DA score and risk for radiographic
progression (RP). The studies included had more than 800
patients with rheumatoid arthritis (RA) who received conventional
DMARDs alone or with adalimumab, infliximab or abatacept.
Overall rates of RP were 10 to 26 percent. In each
study, RP was most frequent among patients with a high vs.
low/moderate Vectra DA score (>44 vs. ≤44). Patients with
high Vectra DA scores, were 3.6 to 9.5 times as likely as patients
with low Vectra scores to develop RP (P=0.002 to <0.0001).
The data from this study are summarized in Table 1.
TABLE 1: Association between radiographic
progression and high Vectra DA score (>44)
Study |
N |
Overall (%) RP
|
Relative Risk |
P-Value |
Leiden1 |
163 |
17% |
4.3 |
<0.0001 |
OPERA2Year 1 |
164 |
26% |
9.5 |
0.0009 |
SWEFOT3Year 1 |
235 |
18% |
7.1 |
0.008 |
Meta-Analysis (Leiden + OPERA + SWEFOT Year 1
|
5.1 |
<0.0001 |
SWEFOT4Year 2 |
133 |
13% |
6.2 |
0.0001 |
AMPLE 5Year 1 (Abatacept) |
181 |
10% |
4.5 |
0.003 |
AMPLE5 Year 1 (Adalimumab)
|
186 |
11% |
3.6 |
0.002 |
|
|
|
|
|
A meta-analysis of the Leiden, SWEFOT Year 1 and OPERA Year 1
studies, showed that patients with a high Vectra DA score were 5.1
times as likely to develop RP (P<0.0001). In comparison,
patients were 1.4 times as likely to develop RP as measured by
DAS28-CRP (P=0.23) and 1.6 times as likely as measured by CRP alone
(P=0.01), underscoring the superior predictive power of Vectra DA
compared with conventional assays (Graph 1).
_________________________________1 LEIDEN: van der Helm-van
Mil et al. Rheumatology (Oxford).
2013;53:839–846. 2 OPERA: Brahe et al. Arthritis
Rheumatol. ACR 2016 Abstract 2520.3 SWEFOT Year 1:
Hambardzumyan K, et al. Ann Rheum Dis.
2015;74:1102–9. 4 SWEFOT Year 2: Hambardzumyan K et al.
RMD Open. 2016 Mar 1;2(1):e000197.5 Curtis et al. Arthritis
Rheumatol. 2016 Nov 3. doi: 10.1002/art.39981 and Fleischmann et
al. Arthritis Rheumatol. 2016 Dec 19.
DOI: 10.1002/art.40021.
Graph 1: Meta-analysis Showing Relative Risk of
Radiographic Progression for Patients with High vs. Low Scores for
Vectra DA, DAS28-CRP or CRP.
The graph is available for download
here: http://www.globenewswire.com/NewsRoom/AttachmentNg/dbb9131d-1400-4d88-b0a6-0499c3e42ddc
“In this meta-analysis, the Vectra DA test has demonstrated the
superior ability to predict joint damage compared with traditional
measures such as DAS28-CRP or CRP, making Vectra DA an important
tool in the management of patients with RA,” said Hitraya.
“Importantly, Vectra DA also demonstrated clinical value by
identifying patients with little or no risk of RP. We believe
combining the Vectra DA score with conventional clinical measures
will enable physicians to individualize treatment plans for their
patients, improve outcomes and reduce the burden of future
healthcare costs associated with this disabling disease.”
The efficacy of Vectra DA has been proven in more than 35
studies with more than 3,000 patients. The clinical utility for
Vectra DA has been widely recognized as three out of four
rheumatologists have used Vectra DA and have ordered it for more
than 300,000 patients in the United States. Recently, Vectra
DA was included in guidelines published by United Rheumatology and
will be evaluated for inclusion in the American College of
Rheumatology (ACR) guidelines. Additionally, Creaky Joints, a
leading advocacy group for patients with RA added Vectra DA to its
professional guidelines, which underscores the importance of Vectra
DA to the patient community.
About Vectra® DA Vectra DA is the only
multi-biomarker blood test for rheumatoid arthritis 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
predict radiographic progression and 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 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, 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
relating to the Vectra DA data to be presented at the 2017 Annual
European Congress of Rheumatology (EULAR) Annual Meeting, June
14-17, 2017 in Madrid; the ability of Vectra® DA to predict
permanent joint damage; the Company’s ongoing commitment to
collaborate with academic researchers to advance the treatment of
rheumatoid arthritis; any potential review of medical guidelines
for rheumatoid arthritis in light of the advances being made in
molecular biomarkers for RA; the potential clinical utility of the
Vectra DA study results and findings for guiding treatment
decisions in patients with RA; the combination of the Vectra DA
score with conventional clinical measures enabling physicians to
individualize treatment plans for their patients, improve outcomes
and reduce the burden of future healthcare costs associated with
RA; and the Company's strategic directives under the captions
"About Crescendo Bioscience" 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 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
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as any updates to those risk factors filed from time to time in our
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Media Contact:
Ron Rogers
(908) 285-0248
rrogers@myriad.com
Investor Contact:
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sgleason@myriad.com
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