Crescendo Bioscience Announces Four Studies with Vectra® DA Will Be Presented at the American College of Rheumatology 2016 Annual Meeting
Studies Advance the Knowledge of Vectra DA Utility for Clinicians and Patients with RA
SALT LAKE CITY, Utah, Nov. 12, 2016 – Crescendo Bioscience, a wholly-owned subsidiary of Myriad Genetics, Inc. (NASDAQ: MYGN), today announced that four poster presentations on Vectra® DA will be featured at the American College of Rheumatology (ACR) meeting being held Nov. 11-16, 2016 in Washington, D.C.
“Crescendo is pioneering a personalized medicine approach for autoimmune disorders and is committed to helping all patients with rheumatoid arthritis achieve their treatment goals,” said Elena Hitraya, M.D., Ph.D., chief medical officer, Crescendo Bioscience. “We are excited about the new data being presented at ACR, including data presented by our collaborators that advance the science of Vectra DA. These findings provide additional information for rheumatologists as they optimize the care of their RA patients.”
Please plan to visit Crescendo at Booth #323 for more information about Vectra DA. Abstracts are available online at: http://acrabstracts.org/meetings/2016-acrarhp-annual-meeting/. Follow Vectra DA on Twitter via @VectraDA and Myriad via @MyriadGenetics to stay informed about news and updates from the Company.
- Title: Examination of Diurnal and Daily Variation of the Multi-biomarker Disease Activity (MBDA) Score in RA to Establish a Minimally Important Difference.
Presenter: David Chernoff
Date: Poster Session A, Sunday, Nov. 13, 2016: 9:00-11:00 a.m. ET.
This study evaluated the biological variability in Vectra DA scores over a 24-hour period and day-to-day in 28 patients with rheumatoid arthritis (RA) with the goals of determining a minimally important difference (MID) and establishing a cut point for a meaningful change in Vectra DA scores over time. The results showed that, based on the short-term variability in the Vectra DA score among stable RA patients tested serially over time, the MID in the score was 9 units. Changes exceeding this threshold are unlikely due to diurnal and daily biological variations alone. Based on these data, blood samples for Vectra DA testing taken during normal office hours (8:00 a.m. to 5:00 p.m.) would not be expected to be impacted by a diurnal variation in the Vectra DA score in clinically stable patients.
- Title: Biomarker-Related Risk for Myocardial Infarction and Serious Infections in Patients with Rheumatoid Arthritis: A Population-Based Study.
Presenter: Jeff Curtis
Date: Poster Session B, Monday, Nov. 14, 2016: 9:00-11:00 a.m. ET.
This study evaluated the utility of Vectra DA in assessing the risk of cardiovascular outcomes and serious infections in a large U.S. Medicare claims database of patients with RA (approximately 17,000 patients with linkable Vectra DA scores). Researchers examined the relationship between the Vectra DA score and the risk of developing infections requiring hospitalization, myocardial infarction (MI) and a composite coronary heart disease (CHD) outcome, including percutaneous coronary intervention and coronary artery bypass graft. The results showed that high Vectra DA scores were associated with an increased risk for all of these outcomes. These findings indicate that the use of the Vectra DA score to risk-stratify patients for these serious adverse events may help clinicians identify those at highest risk.
- Title: Predicting Flare and Sustained Clinical Remission After Adalimumab Withdrawal Using the Multi-Biomarker Disease Activity (MBDA) Score.
Presenters: Shintaro Hirata, Yoshiya Tanaka
Date: Poster Session C, Tuesday, Nov. 15, 2016: 9:00-11:00 a.m. ET.
This study evaluated the Vectra DA (MBDA) score as a predictor of flare or sustained clinical remission after discontinuation of adalimumab (ADA) in patients with established RA from the HONOR study. The analysis included 42 patients receiving ADA and methotrexate (MTX) who maintained DAS28-ESR remission (<2.6) for ≥24 weeks and agreed to discontinue their ADA. Clinical disease activity, functional status and joint damage were recorded at ADA discontinuation (baseline) and after 24 and 52 weeks. Vectra DA scores were measured at ADA discontinuation, and the ability of Vectra DA to predict flare or remission was assessed at six months and one year. All patients had DAS28-ESR <2.6 at baseline and the median Vectra DA score at baseline was 24.5 with 22 patients in remission, six with low, nine with moderate and five with high Vectra DA scores. At 52 weeks, the rate of flare and sustained remission by Vectra DA category (remission/low/moderate/high) was 13.6, 50.0, 33.3 and 60.0 percent (p=0.033) and 63.6, 33.3, 33.3, and 0 percent (p=0.0066), respectively. These findings suggest that the Vectra DA score could predict flare and biologic-free remission in patients in stable remission undergoing ADA withdrawal while maintaining MTX treatment. The results point to the potential clinical utility of Vectra DA for guiding treatment decisions in patients with RA.
- Title: Multi-Biomarker Disease Activity (MBDA) Score and Prediction of Radiographic Progression in a Randomized Study of Patients with Early RA Treated with Methotrexate Alone or with Adalimumab.
Presenter: Cecilie H. Brahe
Date: Poster Session C, Tuesday, Nov.15, 2016: 9:00-11:00 a.m. ET.
The objectives of this study were to evaluate 180 early RA patients from the OPERA trial for associations between the baseline Vectra DA score and 12-month radiographic outcomes, and to assess the value of adding the Vectra DA score to the anti-cyclic citrullinated peptide (anti-CCP) status for predicting radiographic progression (RP). The results showed that a high baseline Vectra DA score was a strong, independent predictor of RP and it added value to anti-CCP status. Patients with a high baseline Vectra DA score (>44) were more likely to progress radiographically (31 percent), while only three percent of patients with a score (≤44) progressed (p<0.01). High versus moderate baseline DAS-CRP was not associated with RP (p=1.0). 34 percent of anti-CCP positive and 12 percent of anti-CCP negative patients had RP (p<0.002); however, none of the anti-CCP positive patients with a Vectra DA score ≤44 progressed radiographically, whereas stratifying by DAS-CRP had no added value to the anti-CCP alone. These data further support the ability of Vectra DA to predict radiographic progression.
About Rheumatoid Arthritis
Rheumatoid arthritis is a chronic, systemic inflammatory condition that is often characterized by symptoms that include pain, stiffness and inflammation of the joints, and in some cases, joint destruction and disability. An estimated 1.5 million Americans have the condition, which affects nearly three times as many women as men. While the cause of RA is unknown, many cases are believed to result from genetic and environmental factors.
About Vectra® DA
Vectra DA is the only multi-biomarker blood test for rheumatoid arthritis 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 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, EndoPredict, myPath, myRisk, Myriad myRisk, myRisk Hereditary Cancer, myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx, myChoice HRD, Vectra, Prolaris and GeneSight 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 relating to the Vectra DA data to be presented at the 2016 American College of Rheumatology (ACR) Annual Meeting, Nov. 11-16, 2016 in Washington, D.C.; the potential clinical utility of the Vectra DA study results and findings for guiding treatment decisions in patients with RA; 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.