Crescendo Bioscience Highlights New Clinical Data on Vectra® DA at ACR
Crescendo Bioscience Highlights New Clinical Data on Vectra® DA at ACR
Data Show Vectra DA Is Better Predictor of Joint Damage in RA Patients
SALT LAKE CITY, Utah, Nov. 19, 2014 – Crescendo Bioscience, a wholly-owned subsidiary of Myriad Genetics, Inc. (NASDAQ: MYGN), today presented new data that showed Vectra® DA is a better predictor of radiographic progression over two years than other tests used to assess risk of joint damage in rheumatoid arthritis (RA), such as C-reactive protein (CRP). The oral presentation was featured at the 2014 American College of Rheumatology (ACR) Annual Meeting in Boston, Massachusetts.
The study included 143 patients with RA who had received a stable treatment and were enrolled in the Brigham and Women’s Rheumatoid Arthritis Sequential Study (BRASS) registry in the United States. Patients were evaluated at their initial visit in the BRASS registry for the Vectra DA score and conventional measures of disease activity, including CRP, DAS28-CRP, CDAI, SDAI and RAPID3, and provided X-rays of hands and wrists at approximately the initial visit and two years later. These data were used to assess the relationship between disease activity and the amount of subsequent new joint damage seen on X-rays (radiographic progression).
The results showed that Vectra DA was the best independent predictor of disease progression over two years when compared with standard measures based on the exam or patient reported outcome. The odds ratio for predicting progression was highest for Vectra DA and lowest for RAPID3. Importantly, among patients with a low CRP at baseline, defined as <1 mg/dL, radiographic progression was observed in 34.8 percent of patients with a high Vectra DA score versus 8.1 percent of patients with a low/moderate Vectra DA score (p=0.003), providing further evidence that Vectra DA provides information for predicting joint damage that is not provided by CRP.
“In this study of U.S. patients, Vectra DA was a strong predictor of joint damage over two years, compared with other tests,” said Eric Sasso, M.D., vice president of medical and scientific affairs at Crescendo Bioscience. “These data build on prior studies demonstrating that Vectra DA can assess risk for joint damage and complement other measures of disease activity.”
Another study featured at ACR provided an analysis of radiographic progression in patients with early RA from the Swedish Farmacotherapy (SWEFOT) clinical trial. The Vectra DA test was used to evaluate 220 patients for progression from baseline to Year 1 and from baseline to Year 2. In addition, progression from Year 1 to Year 2 was evaluated for 133 patients who had inadequate initial responses to methotrexate and were treated from month three with the addition of a TNF inhibitor or with triple therapy using methotrexate, sulfasalazine and hydroxychloroquine.
Among patients with a high Vectra DA score at baseline, 25 percent of those with a high Vectra DA score at month three showed rapid radiographic progression during the first year, and 35 percent of those with a high Vectra DA score at one year showed rapid radiographic progression between Year 1 and Year 2. By contrast, for patients whose high baseline Vectra DA score declined to low after three months or one year of treatment, only 6 and 4 percent showed rapid radiographic progression between Year 1 and Year 2. Moreover, for patients who had a moderate Vectra DA score at baseline and achieved a low Vectra DA score at 3 months, none showed rapid radiographic progression during the first year.
“In this study, a high Vectra DA score was associated with markedly increased risk for joint damage and a low Vectra DA score was associated with low risk for subsequent joint damage,” said Dr. Sasso. “These findings suggest how Vectra DA may be used to objectively assess disease activity following initiation of therapy to help manage the patient’s 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, 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 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, BART, BRACAnalysis, Colaris, Colaris AP, myPath, myRisk, myRisk Hereditary Cancer, myChoice, myPlan, BRACAnalysis CDx, HRD, Vectra and Prolaris are trademarks or registered trademarks of Myriad Genetics, Inc. in the United States and foreign countries. MYGN-F, MYGN.
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 to be presented at the 2014 American College of Rheumatology (ACR) Annual Meeting, November 15-19, 2014, in Boston, Massachusetts; 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 objectively predict disease progression in patients newly diagnosed with rheumatoid arthritis (RA); claims that Vectra DA is a better predictor of joint damage than standard diagnostics; 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 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 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, including unexpected costs and delays; 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 and any future tests and services 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 our projections about our business, results of operations and financial condition; risks related to the potential market opportunity for our products 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 or other intellectual property; 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; 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, 2014, 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.