Crescendo Bioscience, a wholly-owned subsidiary of Myriad Genetics,
Inc. (NASDAQ:MYGN), today announced that four poster presentations
on Vectra® DA will be featured at the American College of
Rheumatology (ACR) meeting being held Nov. 11-16, 2016 in
Washington, D.C.
“Crescendo is pioneering a personalized medicine approach for
autoimmune disorders and is committed to helping all patients with
rheumatoid arthritis achieve their treatment
goals,” said Elena Hitraya, M.D., Ph.D., chief
medical officer, Crescendo Bioscience. “We are excited about
the new data being presented at ACR, including data presented by
our collaborators that advance the science of Vectra DA. These
findings provide additional information for rheumatologists as they
optimize the care of their RA patients.”
Please plan to visit Crescendo at Booth #323 for more
information about Vectra DA. Abstracts are available online
at:
http://acrabstracts.org/meetings/2016-acrarhp-annual-meeting/.
Follow Vectra DA on Twitter via @VectraDA and Myriad via
@MyriadGenetics to stay informed about news and updates from the
Company.
Poster Presentations
- Title: Examination of Diurnal and Daily
Variation of the Multi-Biomarker Disease Activity (MBDA) Score in
RA to Establish a Minimally Important
Difference.Presenter: David
ChernoffDate: Poster Session A, Sunday, Nov. 13,
2016: 9:00-11:00 a.m. ET.Abstract: 535.
This study evaluated the biological variability in Vectra DA
scores over a 24-hour period and day-to-day in 28 patients with
rheumatoid arthritis (RA) with the goals of determining a minimally
important difference (MID) and establishing a cut point for a
meaningful change in Vectra DA scores over time. The results
showed that, based on the short-term variability in the Vectra DA
score among stable RA patients tested serially over time, the MID
in the score was 9 units. Changes exceeding this threshold
are unlikely due to diurnal and daily biological variations alone.
Based on these data, blood samples for Vectra DA testing taken
during normal office hours (8:00 a.m. to 5:00 p.m.) would not be
expected to be impacted by a diurnal variation in the Vectra DA
score in clinically stable patients.
- Title: Biomarker-Related Risk for Myocardial
Infarction and Serious Infections in Patients with Rheumatoid
Arthritis: A Population-Based Study.Presenter:
Jeff CurtisDate: Poster Session B, Monday, Nov.
14, 2016: 9:00-11:00 a.m. ET.Abstract: 1492.
This study evaluated the utility of Vectra DA in assessing the
risk of cardiovascular outcomes and serious infections in a large
U.S. Medicare claims database of patients with RA (approximately
17,000 patients with linkable Vectra DA scores). Researchers
examined the relationship between the Vectra DA score and the risk
of developing infections requiring hospitalization, myocardial
infarction (MI) and a composite coronary heart disease
(CHD) outcome, including percutaneous coronary intervention and
coronary artery bypass graft. The results showed that high Vectra
DA scores were associated with an increased risk for all of these
outcomes. These findings indicate that the use of the Vectra
DA score to risk-stratify patients for these serious adverse events
may help clinicians identify those at highest risk.
- Title: Predicting Flare and Sustained Clinical
Remission After Adalimumab Withdrawal Using the Multi-Biomarker
Disease Activity (MBDA) Score. Presenters:
Shintaro Hirata, Yoshiya TanakaDate: Poster
Session C, Tuesday, Nov. 15, 2016: 9:00-11:00 a.m.
ET.Abstract: 2639.
This study evaluated the Vectra DA (MBDA) score as a predictor
of flare or sustained clinical remission after discontinuation of
adalimumab (ADA) in patients with established RA from the HONOR
study. The analysis included 42 patients receiving ADA and
methotrexate (MTX) who maintained DAS28-ESR remission (<2.6) for
≥24 weeks and agreed to discontinue their ADA. Clinical
disease activity, functional status and joint damage were recorded
at ADA discontinuation (baseline) and after 24 and 52 weeks.
Vectra DA scores were measured at ADA discontinuation, and the
ability of Vectra DA to predict flare or remission was assessed at
six months and one year. All patients had DAS28-ESR <2.6 at
baseline and the median Vectra DA score at baseline was 24.5 with
22 patients in remission, six with low, nine with moderate and five
with high Vectra DA scores. At 52 weeks, the rate of flare
and sustained remission by Vectra DA category
(remission/low/moderate/high) was 13.6, 50.0, 33.3 and 60.0 percent
(p=0.033) and 63.6, 33.3, 33.3, and 0 percent (p=0.0066),
respectively. These findings suggest that the Vectra DA score
could predict flare and biologic-free remission in patients in
stable remission undergoing ADA withdrawal while maintaining MTX
treatment. The results point to the potential clinical
utility of Vectra DA for guiding treatment decisions in patients
with RA.
- Title: Multi-Biomarker Disease Activity (MBDA)
Score and Prediction of Radiographic Progression in a Randomized
Study of Patients with Early RA Treated with Methotrexate Alone or
with Adalimumab.Presenter: Cecilie H.
BraheDate: Poster Session C, Tuesday, Nov. 15,
2016: 9:00-11:00 a.m. ET.Abstract: 2520.
The objectives of this study were to evaluate 180 early RA
patients from the OPERA trial for associations between the baseline
Vectra DA score and 12-month radiographic outcomes, and to assess
the value of adding the Vectra DA score to the anti-cyclic
citrullinated peptide (anti-CCP) status for predicting radiographic
progression (RP). The results showed that a high baseline
Vectra DA score was a strong, independent predictor of RP and it
added value to anti-CCP status. Patients with a high baseline
Vectra DA score (>44) were more likely to progress
radiographically (31 percent), while only three percent of patients
with a score (≤44) progressed (p<0.01). High versus
moderate baseline DAS-CRP was not associated with RP (p=1.0). 34
percent of anti-CCP positive and 12 percent of anti-CCP negative
patients had RP (p<0.002); however, none of the anti-CCP
positive patients with a Vectra DA score ≤44 progressed
radiographically, whereas stratifying by DAS-CRP had no added value
to the anti-CCP alone. These data further support the ability
of Vectra DA to predict radiographic progression.
About Rheumatoid ArthritisRheumatoid arthritis
is a chronic, systemic inflammatory condition that is often
characterized by symptoms that include pain, stiffness and
inflammation of the joints, and in some cases, joint destruction
and disability. An estimated 1.5 million Americans have
the condition, which affects nearly three times as many women as
men. While the cause of RA is unknown, many cases are believed to
result from genetic and environmental factors.
About Vectra® DA Vectra DA is the only
multi-biomarker blood test for rheumatoid arthritis 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 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, EndoPredict, myPath, myRisk, Myriad myRisk, myRisk Hereditary
Cancer, myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx,
myChoice HRD, Vectra, Prolaris 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
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
2016 American College of Rheumatology (ACR) Annual Meeting, Nov.
11-16, 2016 in Washington, D.C.; the potential clinical utility of
the Vectra DA study results and findings for guiding treatment
decisions in patients 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
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
(801) 584-3065
rrogers@myriad.com
Investor Contact:
Scott Gleason
(801) 584-1143
sgleason@myriad.com
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