SALT LAKE CITY, Utah, June 10, 2014 – Crescendo Bioscience, a wholly-owned subsidiary of Myriad Genetics, Inc. (NASDAQ: MYGN), today announced that Vectra® DA data will be featured in eight posters at the 2014 European League Against Rheumatism (EULAR) Annual Meeting, June 11-14, 2014, in Paris, France. Vectra DA is a quantitative, objective multi-biomarker test to measure disease activity in patients with rheumatoid arthritis (RA). The Vectra DA test offers insight into the biological processes that drive disease activity to help rheumatologists manage RA and improve patient care.
At EULAR, data will be presented by researchers from the Swedish Farmacotherapy (SWEFOT) clinical trial that demonstrate the clinical utility of Vectra DA in assessing the risk of future joint damage at multiple points in time. Additionally, SWEFOT data indicate that changes in Vectra DA scores were associated with favorable response to both non-biologic and biologic therapies. Further, the data demonstrate that Vectra DA may have the potential to serve as an inclusion criterion for assessing patients who are candidates for clinical trials in rheumatoid arthritis.
"The breadth of data presented at EULAR is representative of the clinical utility of Vectra DA in the overall management of RA," said Oscar Segurado, chief medical officer at Crescendo Bioscience. "Vectra DA provides physicians with important, actionable insight to better assess risk of radiographic progression as well as manage therapy decisions in their patients with a precise and standardized tool. The EULAR data also point out the opportunity to identify more patients that may be eligible to participate in clinical trials."
The data to be presented at this EULAR meeting will build on a recently published study in the journal Annals of Rheumatic Diseases that demonstrated that Vectra DA scores at the start of the SWEFOT clinical study predicted radiographic progression of joint damage over the following year. The new data from the SWEFOT study being presented at EULAR demonstrate that Vectra DA scores at 3 months and 12 months also were predictive of subsequent radiographic progression over the following 2 years. Additionally, patients in the SWEFOT study who did not respond to 3 months of initial methotrexate therapy were randomized to receive either non-biological DMARD triple therapy or anti-TNF (infliximab) therapy. Patients with a high Vectra DA score at baseline that remained high following therapy were at a high risk for radiographic progression. By contrast, risk for progression was significantly lower among patients with a high Vectra DA score at baseline, but lower Vectra DA score following treatment. At all measured time points, low Vectra DA scores were associated with low risk for subsequent radiographic progression.
"These are clinically relevant findings for rheumatologists taking care of patients with RA," said Ronald F. van Vollenhoven, M.D., Ph.D, Department of Medicine, Karolinska Institute in Stockholm, Sweden. "These data show that Vectra DA may help identify those patients at higher and lower risks for radiographic progression while receiving antirheumatic therapy."
Poster Tour Presentations
Title: Using the multi-biomarker disease activity score as a complementary inclusion criterion for clinical trials in rheumatoid arthritis may enhance recruitment.
Presenter: Ronald van Vollenhoven
Date: Presentation: June 13, 2014 12:00 PM, Room 251
Poster: June 14, 2014; 10:15 AM, Poster Area D, Level 4
Key Finding: In this analysis of the SWEFOT study, Vectra DA was found to be potentially useful as an inclusion criterion in clinical trials. Recruitment for clinical trials in patients with active RA may be enhanced by including patients with a Vectra DA score > 44 in addition to the conventional approach of only using patients with a CRP > 10 mg/L. This enhancement was achieved with a comparable response to treatment and subsequent radiographic progression. In this study the number of eligible DMARD naïve patients increased by 24 percent and the number of eligible MTX Non-responder patients increased by 47 percent.
Title: Multi-biomarker disease activity (Vectra DA algorithm) score is associated with power doppler ultrasound in patients with rheumatoid arthritis in low disease activity state: The Remira Cohort.
Presenter: Margaret H. Ma
Date: Presentation: June 12, 2014; 12:00 PM; Level 2 Paris Room
Poster: June 14, 2014; 10:15 AM, Poster Area D, Level 4
Key Finding: Vectra DA can detect joint inflammation despite the lack of clinical
disease activity in RA patients. Among patients who had low clinical disease activity or were in remission, Vectra DA algorithm score correlated with the amount of joint inflammation (synovitis) detected by ultrasound imaging of joints.
Title: A multi-biomarker disease activity blood test in patients with juvenile idiopathic arthritis (JIA).
Presenter: Kunihiro Yamaoka
Date: Presentation: June 12, 2014; 12:00 PM; Room 251
Poster: June 13, 2014; 11:45 AM, Poster Area D, Level 4
Key Finding: Researchers found a significant association between the
multi-biomarker disease activity score and clinical disease activity in patients
with juvenile arthritis. Further assessment of the clinical value of a
multi-biomarker disease activity test for JIA is warranted.
Poster Presentations
Title: In early RA, the multi-biomarker disease activity score at different time-points is predictive of subsequent radiographic progression.
Presenter: Karen Hambardzumyan
Date: June 14, 2014; 10:15 AM; Poster Area D, Level 4
Key Finding: This SWEFOT study found that Vectra DA scores at baseline and changes over time were predictive of radiographic progression for up to two years. These results, along with data recently published online in the Annals of Rheumatic Disease, further validate the finding that low/high scores of Vectra DA are associated with less/more joint damage over time.
Title: In early RA patients with non-response to methotrexate the change in multi-biomarker disease activity score is differentially associated with subsequent response to non-biological versus biological therapy.
Presenter: Karen Hambardzumyan
Date: June 13, 2014; 11:45 AM; Poster Area D, Level 4
Key Finding: This SWEFOT study suggests that changes in the Vectra DA score may help guide subsequent therapy. In DMARD-naïve patients who had inadequate responses to 3 months of methotrexate, the changes in Vectra DA score at month 3 were associated with the likelihood of having a subsequent response to either anti-TNF or triple (DMARD) therapy.
Title: Validation of a multi-biomarker disease activity score in rheumatoid arthritis in relation to imaging inflammation and damage.
Presenter: Simon Krabbe
Date: June 13, 2014; 11:45 AM, Poster Area D, Level 4
Key Finding: Vectra DA correlated with imaging measures of joint inflammation and joint damage, providing further evidence that the test is associated with biological processes of disease in RA joints.
Title: Residual inflammatory activity assessed by a multi-biomarker disease activity blood test is linked to structural damage in RA patients in low disease activity/remission and normal C-reactivity protein level.
Presenter: Georg Schett
Date: June 12, 2014; 11:45 AM, Poster Area D, Level 4
Key Finding: In RA patients who were in clinical remission or low clinical disease activity, Vectra DA was found to correlate with erosive damage in joints, as detected by imaging with high-resolution CT scanning, suggesting that the inflammatory mediators measured by Vectra DA are linked to structural bone damage in RA.
Title: Effects of tofacitinib treatment on leptin and other components of the multi-biomarker disease activity score in patients with rheumatoid arthritis.
Presenter: Kunihiro Yamaoka
Date: June 13, 2014; 11:45 AM, Poster Area D, Level 4
Key Finding: Using Vectra DA to evaluate treatment response in a clinical trial of the biologic agent tofacitinib, researchers found that the biomarker leptin increased with active treatment.
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, http://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: http://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: http://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 to be presented at the 2014 European League Against Rheumatism (EULAR) Annual Meeting, June 11, 2014, in Paris, France; 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); 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.