Crescendo Bioscience's Vectra® Da Predicts Radiographic Progression In Patients With Early Rheumatoid Arthritis
5/14/2014 10:33:20 AM
SALT LAKE CITY, May 14, 2014 (GLOBE NEWSWIRE) -- 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.
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