MedicalResearch.com Interview with:
Executive Vice President, Corporate Communications
Spokesman, Myriad Genetics, Inc.
Salt Lake City, Utah 84108
Medical Research: What is the background for the MBDA test? What types of biomarkers are included in the score?
Response: Vectra DA is an advanced blood test for adults with rheumatoid arthritis (RA). It helps you and your doctor better understand your rheumatoid arthritis disease activity. Vectra DA blood test for RA gives physicians a more complete look at your disease activity by measuring 12 markers of RA disease activity. Some other tests, such as C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR or “sed rate”), only measure one marker.
Vectra DA test scores can help track your disease activity over time with an objective measure that complements your doctor’s exam and your own assessment. Patients with high Vectra DA scores have 7-fold higher risk for rheumatoid arthritis-related joint damage than patients with low or moderate Vectra DA scores.
You can learn more about the specific biomarkers at: http://vectrada.com/health-care-professionals/biomarkers/
Medical Research: How can MBDA testing help clinicians choose initial therapy for Rheumatoid Arthritis patients?
Response: This week, we had three important new presentations at the American College of Rheumatology meeting in San Francisco including some of the first clinical studies to show the potential of Vectra DA to guide the treatment regimen. The ability to choose therapy that can provide the best clinical outcome for patients while delivering health economic benefits presents a promising opportunity.
The first study evaluated the ability of Vectra DA to predict responses to two treatment regimens: triple therapy or biologic, in patients who fail to respond completely to methotrexate therapy. In this study, those patients with lower Vectra DA scores were more likely to respond to less expensive triple therapy while those patients with higher Vectra DA scores were more likely to respond to anti-TNF therapy.
The second study evaluated the ability of Vectra DA to predict flares in patients discontinuing anti-TNF therapy. In this study, patients with a high Vectra DA score had a risk of flare within 12 months twice as high as patients with a low Vectra DA score.
The third study evaluated the ability of Vectra DA to predict relapse in patients tapering their disease modifying anti-rheumatic drugs. In this study, Vectra DA scores were significantly higher in patients relapsing relative to those in stable remission.
These last two studies could provide guidance to physicians in determining which patients could taper their drug therapies, thereby reducing treatment burden and costs while maintaining patient care.
Medical Research: Is MBDA testing currently available to clinicians? Is the test covered by major insurers?
Response: Yes. Vectra DA is available and is being used by approximately 40% of rheumatologists in the United States. The test is covered by Medicare which pays for two tests per patient, per year.
From a private payer perspective, we continue to execute on our three-pronged strategy for private payer reimbursement. We are in the process of updating the current reimbursement dossier and health economics model to more favorably represent our substantial existing clinical validation, utility, and economic validity data. This update will incorporate past publications and upcoming new publications at ACR to show the potential of Vectra DA to guide treatment decisions for right patients while reducing cost to the health care system. We have with this revised dossier, reinitiated dialogue with private payers to discuss the clinical utility of Vectra DA in managing their RA patients.
Medical Research: What recommendations do you have for future research as a result of this studies?
Response: Crescendo has 15 ongoing collaborations with pharmaceutical companies. Also, we are completing the plans for our prospective clinical utility study and plan to initiate enrollment in early calendar year 2016
Abstracts Presented at the ACR 2015 in November 2105
Title: The multi-biomarker disease activity score in methotrexate incomplete responders predicts clinical responses to non-biological vs. biological therapy in early RA. Authors: K. Hambardzumyan, R. Bolce, S. Saevarsdottir, K. Forslind, J.A. Karlsson and R.F. van Vollenhoven.
Title: Prediction of disease relapses by multi-biomarker disease test activity in rheumatoid arthritis patients tapering DMARD treatment. Authors: J. Rech, A.J. Hueber, M. Englbrecht, S. Finzel, J. Haschka, B. Manger, A. Kleyer, M. Reiser, H-P Tony, S. Kleinert, M. Feuchtenberger, M. Fleck, K. Manger, W. Ochs, M. SchmittHaendle, J. Wendler, F. Schuch, M. Ronneberger, H-M Lorenz, H. Nüßlein, R. Alten, J. Fogagnolo Cobra, J.C. Henes, K. Krüger and G.A. Schett. Date: Tuesday, Nov. 10, 2015: 9:00 – 11:00 a.m. PT. Location: Poster, Abstract: 2584.
Title: Multi-biomarker disease activity score as a predictor of flare in patients with rheumatoid arthritis who stop TNF-alpha-inhibitor therapy. Authors: F. Lamers-Karnebeek, M. Ghiti Moghadam, H.E. Vonkeman, J. Tekstra, A. Schilder, H. Visser, P.M. ten Klooster, E.H. Sasso, D. Chernoff, W. Lems, D. van Schaardenburg, R. Landewé, L. Van Albada, T.R.D.J. Radstake, P. van Riel, M.A.F.J. van de Laar and T. Jansen. Date: Tuesday, Nov. 10, 2015: 9:00 – 11:00 a.m. PT. Location: Poster, Abstract: 2594.
Ron Rogers (2015). MBDA Biomarker Score Predicts Rheumatoid Arthritis Disease Activity