New Data Show Importance of Vectra® Testing and Biomarkers in Predicting Risk for Cardiovascular Events in Patients with Rheumatoid Arthritis

SALT LAKE CITY, Nov. 11, 2020 (GLOBE NEWSWIRE) -- At the annual meeting of the American College of Rheumatology (ACR), Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in molecular diagnostics and precision medicine, shared new data further demonstrating that Vectra^® testing and three additional biomarkers, combined with traditional risk factors, can predict the risk of cardiovascular (CV) events in patients with rheumatoid arthritis (RA). Also, presented at the meeting was a study showing that Vectra is a significant predictor for joint damage, and is a better predictor than several tested subjective measures. Vectra is an advanced blood test that objectively measures inflammation caused by RA.

“Due to inflammatory processes, patients with RA have approximately 50% greater risk for cardiovascular disease (CVD), the leading cause of mortality among patients with RA, which accounts for 30-40% of deaths.” said Elena Hitraya, M.D., Ph.D., rheumatologist and chief medical officer at Myriad Autoimmune. “The data shows that a newly developed Multi-Biomarker Based CVD Risk Score can accurately predict the risk of major cardiovascular events over the next three years across various subgroups of RA patients. Knowing a patient’s future risk of potential joint damage and cardiovascular events, clinicians can make more informed treatment decisions with the goal of achieving better health outcomes.”

Vectra Posters at ACR
Title: External Validation of a Multi-Biomarker-Based Cardiovascular Disease Risk Prediction Score for Rheumatoid Arthritis Patients
Virtual Poster Location:https://acrabstracts.org/abstract/external-validation-of-a-multi-biomarker-based-cardiovascular-disease-risk-prediction-score-for-rheumatoid-arthritis-patients/
This validation study assessed the performance of the Multi-Biomarker-Based Cardiovascular Disease Risk Prediction Score in a non-Medicare patient population. The goal of the study was to validate the risk score in a cohort (N=44,379) with median age of 54 (46-60) years that was younger than, and independent of, the Medicare cohort used for test development. The study found that the Vectra-based CVD risk score (mean 3.3, IQR 2.8-3.8) was a significant predictor of CVD risk, with hazard ratio (HR) = 3.99 (95% CI: 3.52-4.51, p=4.4×10-95); i.e., for every 1-unit increase in the score, the CVD event rate was ~4 times higher.

Title: Performance of the MBDA-based CVD risk score in RA patient groups of clinical interest
Virtual Poster Location:https://acrabstracts.org/abstract/performance-of-the-mbda-based-cvd-risk-score-in-ra-patient-groups-of-clinical-interest/
The purpose of this study was to evaluate the ability of a risk score that combines Vectra, TNF-R1, MMP-3, leptin, age and traditional risk factors (diabetes, hypertension, smoking, history of CVD) to predict 3-year risk for myocardial infarction (MI), stroke, or fatal CVD for RA patients in subgroups of interest. The study found that, in a cohort of 10,275 Medicare patients, with high prevalence of comorbidities, such as diabetes (40%) and hypertension (79%), the Vectra-based CVD risk prediction score had good accuracy overall and in subgroups based on level of a Vectra score, sex, and statin use.

Title: Comparison of MBDA Score, Patient Global Assessment, and Evaluator Global Assessment for Predicting Risk of Radiographic Progression
Virtual Poster Location:https://acrabstracts.org/abstract/comparison-of-mbda-score-patient-global-assessment-and-evaluator-global-assessment-for-predicting-risk-of-radiographic-progression/
In a cohort of 766 patients from one registry and two clinical trials, this study compared Vectra, patient global assessment (PGA), and evaluator global assessment (EGA) in terms of their abilities to predict risk of radiographic progression (RP) (i.e. new joint damage). The study found Vectra significantly predicted risk for RP (Figure 1A in the poster), with univariate OR=1.53, p=5.3x10-8. In contrast, neither PGA nor EGA predicted RP (p=0.38 and 0.47, respectively). Vectra predicted RP regardless of whether PGA and EGA were concordant or discordant.

RA affects more than one million people in the United States. Lost productivity associated with RA is substantial, with approximately 20-70% of individuals working at the time of their RA diagnosis being disabled after seven to 10 years. RA is an inflammatory autoimmune disease that attacks a patient’s joints and often affects other organ systems, contributing to increased disability, significant morbidity, increased mortality and financial burden. The risk of RP, defined as change in total Sharp score >5 units per year, is a function of Vectra score. Increased risk of RP means greater irreversible joint damage.

Three out of four rheumatologists have used Vectra and have ordered more than one million tests for their RA patients. The ACR includes Multi-Biomarker Disease Activity Score (Vectra) as a disease activity measure that meets the minimum standard for regular use for patients with rheumatoid arthritis. Those recommendations were published in the journal Arthritis Care & Research.

About Vectra
Vectra is a multi-biomarker molecular blood test that provides an objective and personalized measure of inflammatory disease activity in patients with rheumatoid arthritis. Vectra demonstrates unsurpassed ability to predict radiographic progression and can help guide medical management decisions to improve patient outcomes. Vectra testing is performed at a state-of-the-art CLIA (Clinical Laboratory Improvement Amendments) facility. Test results are reported to the physician five to seven days from shipping of the specimen. Physicians can receive test results by fax or the private provider web portal, VectraView^TM. For more information on Vectra, please visit: VectraScore.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, Myriad myRisk, myRisk Hereditary Cancer, myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx, myChoice CDx, Vectra, Prequel, Foresight, GeneSight, riskScore 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 Vectra-related posters at the annual meeting of the American College of Rheumatology (ACR); 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: uncertainties associated with COVID-19, including its possible effects on our operations and the demand for our products and services; our ability to efficiently and flexibly manage our business amid uncertainties related to COVID-19; 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 decisions in Mayo Collab. Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012), Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013), and Alice Corp. v. CLS Bank Int’l, 573 U.S. 208 (2014); 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 for the fiscal year ended June 30, 2020, 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.