New Data Demonstrate the Clinical Performance of the Prolaris® and myRisk® Hereditary Cancer Genetic Tests in Men with Prostate Cancer
New Data Demonstrate the Clinical Performance of the Prolaris® and myRisk® Hereditary Cancer Genetic Tests in Men with Prostate Cancer
SALT LAKE CITY, Utah, Nov. 2, 2018 – Myriad Genetics, Inc. (NASDAQ: MYGN), a global leader in personalized medicine, today announced new data from two studies presented at the Western Section of the American Urological Association annual meeting in Maui, HI.
The key results are that the Prolaris® test is superior to adverse pathology at predicting the risk of prostate cancer biochemical recurrence after surgery, and the myRisk® Hereditary Cancer test found one in ten men with prostate cancer carry an inherited genetic mutation in a cancer-causing gene.
“Myriad Genetics is committed to advancing personalized medicine and providing urologists with genetic information to enable better care and outcomes for their patients with prostate cancer.” said Todd Cohen, M.D., vice president of Medical Affairs, Myriad Urology. “At this conference, our collaborators presented two new studies that highlight important clinical benefits of the Prolaris and myRisk Hereditary Cancer tests and provide useful information on how these tests can be used to help guide patient care.”
The key data are summarized below.
Title: Biopsy-Derived Cell Cycle Progression Score Outperforms Pathologic Upgrading or Upstaging in Predicting Biochemical Recurrence after Surgery
Poster Presenter: Daniel Canter, M.D., Oshner Health System.
Date: Sunday, Oct. 28, 2018, 7:30 a.m. - 4:30 p.m. HST.
Abstract: 09-07.
This study compared the Prolaris® test to radical prostatectomy (RP) derived adverse pathology (i.e., upgrading or upstaging) in predicting biochemical recurrence after surgery. The analysis included 557 men with low-risk prostate cancer (Gleason ≤3+4 and clinical stage ≤T2) treated by RP. The Prolaris test score (CCP) was also combined with prostate risk assessment (CAPRA) score to generate a clinical cell-cycle risk score (CCR). Adverse pathology (AP) was defined as upgrading to a post-RP Gleason of ≥4+3 and/or upstaging to post-RP pathological stage ≥T3.
The findings show that the Prolaris test with CAPRA (CCR) was 2.5 times more predictive than adverse pathology in predicting biochemical recurrence after surgery (Chart 1). After accounting for CAPRA, the Prolaris test score (CCP) was >2 times more predictive than adverse pathology (p=0.0008 vs. p=0.018, respectively), confirming that Prolaris provided more prognostic information than AP for predicting surgical failure.
“The findings in this study are novel and appear to indicate that the Prolaris test is a superior predictor of biochemical recurrence compared to the traditional variables associated with adverse pathological features,” said Daniel Canter, M.D., lead investigator and director of Urologic Oncology and Urologic Research at the Oschner Clinic. “Importantly, these results demonstrate the clinical utility of the Prolaris test to help physicians risk stratify men with localized prostate cancer.”
Title: Inherited Germline Mutations in Men with Primary and Secondary Prostate Cancer.
Podium Presenter: Edward Uchio, M.D., University of California.
Date: Friday, November 2, 2018, 8:30 a.m. HST.
Abstract: 09-24.
This is one of the largest-ever studies to assess hereditary cancer genetic testing for men with prostate cancer. It included 2,609 men who met guidelines for testing and were tested with the myRisk® Hereditary Cancer test from 2013 to 2018. Approximately 75 percent of men had prostate cancer only and 25 percent had prostate cancer plus one other type of cancer.
The results demonstrate that 10 percent of men with prostate cancer were found to carry a pathogenic mutation, and the most common mutations were found in the BRCA1/2, ATM, CHEK2 and the MMR genes. In men who had prostate cancer plus another cancer, the likelihood of having a deleterious mutation increased by 60 percent (p=0.013). Importantly, many of the mutations identified in this study were in genes associated with Hereditary Breast and Ovarian Cancer Syndrome and Lynch Syndrome.
“Our study found that the myRisk Hereditary Cancer gene panel identified mutations in a wide range of clinically significant genes that would be missed using a narrower gene panel that only targeted prostate cancer,” said Edward Uchio, M.D., lead investigator, department of Urology, University of California. “These findings support the clinical use of the more comprehensive myRisk Hereditary Cancer test to achieve the best possible results for patients.”
About Prostate Cancer
According the American Cancer Society, more than 165,000 men will be diagnosed with prostate cancer this year, and there are over 2.9 million men in the United States who have been previously diagnosed with prostate cancer that are alive today.
In February 2018, the National Comprehensive Cancer Network (NCCN) issued new medical guidelines for prostate cancer treatment broadly include biomarker testing in prostate cancer. Importantly, the guidelines include language supporting Prolaris as standard-of-care in treatment decision making for patients with low and favorable-intermediate
About Prolaris®
Prolaris is a novel 46-gene RNA-expression test that directly measures tumor cell growth characteristics for stratifying the risk of disease progression in patients with prostate cancer. Prolaris provides a quantitative measure of the RNA expression levels of genes involved in the progression of tumor growth. Low gene expression is associated with a low risk of disease progression in men who may be candidates for active surveillance and high gene expression is associated with a higher risk of disease progression in patients who may benefit from additional therapy. For more information visit: www.prolaris.com.
About Myriad myRisk® Hereditary Cancer
The Myriad myRisk Hereditary Cancer test uses an extensive number of sophisticated technologies and proprietary algorithms to evaluate 28 clinically significant genes associated with the development of eight hereditary cancers including: breast, colon, ovarian, endometrial, pancreatic, prostate and gastric cancers and melanoma. The myRisk Hereditary Cancer test offers physicians several distinct advantages over other commercial tests, including unsurpassed lab accuracy, industry leading variant classification, a medical management tool and exceptional customer service. Men with prostate cancer can take the Hereditary Cancer Quiz to find out if they might be at risk for an inherited mutation and therefore eligible for myRisk Hereditary Cancer test.
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: build upon a solid hereditary cancer foundation, 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: www.myriad.com. Follow Myriad on Twitter via @MyriadGenetics.
Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris AP, myPath, myRisk, Myriad myRisk, myRisk Hereditary Cancer, myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx, myChoice HRD, EndoPredict, Vectra, GeneSight, riskScore Prolaris, ForeSight and Prelude 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 Company’s two studies being presented at the Western Section of the American Urological Association meeting being held Oct. 28 - Nov. 2, 2018 in Maui, HI; 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; 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, 2018, 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.
