Positive Clinical Utility Results of Crescendo’s Vectra® DA Test for Rheumatoid Arthritis Published in the Journal Arthrit...
December 27 2016 - 7:05AM
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) published online in the journal Arthritis
& Rheumatology.1
“This study highlights the clinical utility of the Vectra DA
test to help predict treatment response to biologic and
non-biologic therapies in methotrexate incomplete responders,” said
Elena Hitraya, M.D., Ph.D., chief medical officer, Crescendo
Bioscience. “These results showed that Vectra DA performed
better than clinical and single inflammatory biomarkers at
predicting response to non-biological therapy intensification
versus anti-TNF (infliximab) therapy. This publication adds
to the growing body of data on the use of the Vectra DA test to
help individualize treatment plans and improve health outcomes for
patients with RA.”
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 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 at three months
following treatment with MTX monotherapy were more likely to
respond to triple therapy versus MTX+infliximab (88 percent vs. 18
percent, respectively; p=0.006). In contrast, patients who
had a high Vectra DA score at three months were more likely to
respond to anti-TNF therapy (35 percent vs. 58 percent,
respectively; p=0.040). Importantly, the Vectra DA score at
three months was a better independent predictor of treatment
response at Year 1 than clinical or single inflammatory biomarkers
(CRP, ESR) or DAS28). These results demonstrate that Vectra DA
could 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.
The Vectra DA test is the first and only multi-biomarker blood
test validated to measure disease activity in patients with
RA. Vectra DA has been evaluated in more than 20 studies with
more than 3,000 patients. The value that Vectra DA offers
rheumatologists is demonstrated by the fact that 3 out of 4
rheumatologists have ordered Vectra DA for ~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.
1 Hambardzumyan K, Saevarsdottir S, Forslind K, et
al. A multibiomarker disease activity score and the choice of
second-line therapy in early rheumatoid arthritis after
methotrexate failure. Arthritis Rheumatol. December 19,
2016. Accessed online at:
www.ncbi.nlm.nih.gov/pubmed/27992691.
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 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 published in the
journal Arthritis & Rheumatology; the ability of
Vectra DA to predict or assess treatment response in patients with
rheumatoid arthritis; 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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