Myriad Genetics Collaborates with CareFirst BlueCross BlueShield On Coverage with Evidence Development Study for The Vectra® DA Test
Baltimore, MD and Salt Lake City, UT (November 10, 2017) - CareFirst BlueCross BlueShield (CareFirst) and Myriad Genetics, Inc. (NASDAQ:MYGN), a global leader in molecular diagnostics and personalized medicine, today announced that they have signed an agreement to collaborate on a clinical utility study for the Vectra® DA test in patients with rheumatoid arthritis (RA). Vectra DA is a pioneering test designed to predict whether patients with RA are at risk for radiographic progression (RP) so that rheumatologists can optimize treatment decisions.
The agreement is part of CareFirst’s new Healthworx program that enables CareFirst to work with pioneering companies to bring new technologies and care advances to bear to benefit its members and the organizations insured by CareFirst.
“CareFirst is committed to making timely and informed decisions about molecular diagnostic tests that show potential to improve outcomes and lower costs,” said CareFirst Vice President and Senior Medical Director Daniel Winn, M.D. “Historically, disease activity measures were subjective or not reproducible and as a consequence inconsistently used to guide treatment decisions for RA patients. Given the emerging evidence for Vectra DA, we are excited to work with Myriad and evaluate the benefits of the Vectra DA test for our physicians and members.”
“One of the challenges presented by prostate-specific antigen (PSA) cancer screenings is the relatively high number of false positives detected from PSA results which often fall into a ‘gray’ zone and require further testing through biopsies,” said Dr. Rahul Rajkumar, CareFirst’s Chief Medical Officer. “These prostate biopsies often find the false positives to be benign or low-grade cancers for which treatment or intervention is not clinically indicated. Unfortunately, this course of care can lead to medically unnecessary prostate biopsies and avoidable complications for our members. We are excited about the evidence to date and potential for ExoDx’s EPI test to better inform physicians and members’ decisions on which course of action to pursue when facing a PSA result in the gray zone.”
The 18-month study is designed to show that the use of Vectra DA will lead to better outcomes and reduced costs compared to conventional approaches. The study will be conducted by about 40 rheumatologists in the CareFirst network.
“We are excited to collaborate with CareFirst and further demonstrate the advantage of integrating Vectra DA as a routine part of rheumatoid arthritis patient care,” said Chip Parkinson, executive vice president, Reimbursement Strategies, Myriad Genetics. “We believe this collaborative approach can be replicated with other molecular diagnostics to speed up the reimbursement process for innovative new technologies.”
Vectra DA has been shown in multiple clinical studies to be the best predictor of radiographic progression in RA patients. Importantly, high Vectra DA scores were associated with increased risk for RP in six studies, including patients treated with synthetic or biologic DMARDs. To date, Vectra DA has been used by approximately 70 percent of practicing rheumatologists with more than 350,000 patients to optimize treatment decisions for their patients.
About Vectra® DA
Vectra DA is the most predictive disease activity measure for rheumatoid arthritis and is a multi-biomarker blood test that integrates the concentrations of 12 serum proteins 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 their site.
About CareFirst BlueCross BlueShield
In its 79th year of service, CareFirst, an independent licensee of the Blue Cross and Blue Shield Association, is a not-for-profit health care company which, through its affiliates and subsidiaries, offers a comprehensive portfolio of health insurance products and administrative services to 3.2 million individuals and groups in Maryland, the District of Columbia and Northern Virginia. In 2016, CareFirst invested nearly $44 million to improve overall health, and increase the accessibility, affordability, safety and quality of health care throughout its market areas.
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 five strategic imperatives: stabilizing hereditary cancer revenue, growing new product volume, expanding reimbursement coverage for new products, increasing RNA kit revenue internationally and improving profitability with Elevate 2020. For more information on how Myriad is making a difference, please visit the company's website.
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 Company’s collaboration with CareFirst in the Coverage with Evidence Development (CED) Study for the VectraDA test; the timing, completion and outcome of the Study; the design of the 18-month Study to show that the use of Vectra DA will lead to better outcomes and reduced costs compared to conventional approaches; the number of rheumatologists in the CareFirst network which will conduct the Study; the Company’s excitement to collaborate with CareFirst; further demonstrating the advantage of integrating Vectra DA as a routine part of rheumatoid arthritis patient care; the Company’s belief that this collaborative approach can be replicated with other molecular diagnostics to speed up the reimbursement process for innovative new technologies; and the Company’s strategic directives under the captions “About VectraDA” 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 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 most recent Annual Report on Form 10-K, 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.