Crescendo Bioscience Announces that New Data on Vectra® DA Will Be Presented at the European League Against Rheumatism 17th Annual Congress
Three Studies Demonstrate the Utility of Vectra DA to Help Predict Treatment Response and Remission in Patients with RA
SALT LAKE CITY, Utah, June 10, 2016 – 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) are being presented at European League Against Rheumatism (EULAR) meeting being held June 8-11, 2016, in London. Vectra DA test is the first and only multi-biomarker blood test validated to measure disease activity in patients with RA and has been evaluated in multiple studies, resulting in 23 scientific peer-reviewed publications.
“Our collaborators are presenting three very exciting studies with Vectra DA test at EULAR. These studies highlight the utility of Vectra DA test to predict flare and sustained remission in patients discontinuing treatment, as well as treatment response to biologic and non-biologic therapies,” said Elena Hitraya, M.D., Ph.D., chief medical officer, Crescendo Bioscience. “These results add to the growing body of data on the use of Vectra DA test to measure disease activity, individualize treatment plans and achieve better health outcomes for people with RA.”
A summary of the highlighted Crescendo Bioscience presentations at EULAR (#EULAR2016) follows:
Title: Predictive value of the multi-biomarker disease activity (MBDA) score for flare and sustained remission in the HONOR study.
Authors: S. Hirata, S. Tang, C.C. Hwang, et al.
Date: Friday, June 10, 2016: 11:45 a.m. – 1:30 p.m.
Location: Poster FRI0096.
This study evaluated the predictability of the Vectra DA score for flare and sustained clinical remission after discontinuation of adalimumab (ADA) in 42 patients with RA from the HONOR study. At baseline, 67 percent of patients had a low Vectra DA score and 12 percent had a high Vectra DA score. The results showed that three out of five patients (60 percent) who had an elevated Vectra DA score at discontinuation of ADA developed flare within one year. In parallel, 16 of 28 patients (57 percent) with a low score at discontinuation had sustained clinical remission. These findings suggest that the Vectra DA score can predict flare and sustained remission following ADA discontinuation in patients with established RA and indicate the potential utility of Vectra DA for guiding treatment decisions in patients undergoing a discontinuation or tapering of biologics.
Title: Changes in multi-biomarker disease activity (MBDA) score correlate with changes in established disease activity measurements in patients with early RA from the OPERA study.
Authors: C.H. Brahe, M. Ostergaard, J. Johnsen, et al.
Date: Friday, June 10, 2016: 11:45 a.m. – 1:30 p.m.
Location: Poster FRI0067.
This study investigated the correlation between early changes in the Vectra DA score at 6- and 12-months and established clinical disease activity measures. A total of 180 treatment-naïve patients with early RA were randomized to receive MTX or MTX + adalimumab (ADA). For both treatment groups, statistically significant correlations were observed between changes in Vectra DA scores from baseline to 3- or 6-months and clinical measures including: disease activity score (DAS28), clinical disease activity index (CDAI), simplified disease activity index (SDAI) and C-reactive protein (CRP). Importantly, the Vectra DA score decreased significantly in both treatment arms with the largest decreases observed between baseline and three months and treatment responses were highest for patients in the MTX-ADA arm (P=0.006). The Vectra DA score also was a significant independent predictor of clinical remission at six months (P=0.05), and the remission rate at 12 months was higher in patients with a larger change in Vectra DA score versus those with a smaller change (80 percent vs. 61 percent; P=0.015). These findings support the use of Vectra DA to predict treatment response and remission in patients with early RA.
Title: The multi-biomarker disease activity score in methotrexate incomplete responders predicts clinical responses to non-biological versus biological therapy in early RA.
Authors: K. Hambardzumyan, R. Bolce, S. Saevarsdottir, et al.
Date: Saturday, June 11, 2016: 10:15 – 11:00 a.m.
Location: Poster SAT0066.
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 effectively 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 and/or a larger decrease in the first three months of treatment with MTX monotherapy were more likely to respond to triple therapy. In contrast, patients who had a high Vectra DA score and/or a smaller decrease were more likely to respond to anti-TNF therapy. Importantly, the Vectra DA score at three months was a better independent predictor of treatment response at Year 1 than CRP, ESR and DAS28. These results demonstrate that Vectra DA can 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.
For more information about these presentations, including a complete list of abstracts and presentations, please visit the EULAR website at http://www.congress.eular.org/.
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, 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’s website at www.crescendobio.com.
About Myriad Genetics
Myriad 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 Statement
This 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 to be presented at the European League Against Rheumatism (EULAR) meeting being held June 8-11, 2016, in London; the Company’s commitment to understanding the molecular underpinnings of rheumatoid arthritis and autoimmune disorders; the ability of Vectra DA to predict or assess treatment response in patients with rheumatoid arthritis; and the Company’s strategic directives under the caption “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 set forth in or implied by 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; risks related to our ability to transition from our existing product portfolio to our new tests, including unexpected costs and delays; risks related to decisions or changes in 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 and our healthcare clinic; risks related to public concern over 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 most recent Annual Report on Form 10-K for the fiscal year ended June 30, 2015, 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. 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.