SALT LAKE CITY, May 30, 2013 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (Nasdaq:MYGN) today announced that Jack Cuzick, Ph.D., of Queen Mary College University of London, will present data from five PROLARIS® clinical studies in patients with prostate cancer at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago.
"Myriad is a pioneer and global-leader in molecular diagnostic testing for cancer," said Peter D. Meldrum, president and CEO of Myriad. "PROLARIS is an excellent example of the great promise of personalized medicine for creating a better healthcare system that is equipped to meet the evolving needs of both patients and physicians."
PROLARIS Is the Dominant Predictor of Prostate Cancer Outcomes
Professor Cuzick will present data from an analysis of five clinical studies of PROLARIS on Sunday, June 2 at 9:30 a.m. in E Hall D2 at McCormick Place convention center in Chicago.
"Clinical data show that PROLARIS predicts prostate cancer outcome in multiple patient cohorts and in diverse clinical settings," said Professor Cuzick. "PROLARIS provides independent information beyond clinicopathologic variables and accurately differentiates aggressive prostate cancer from indolent cancer based on real oncologic outcomes."
PROLARIS is the molecular prognostic test for both newly diagnosed and post-prostatectomy prostate cancer patients. PROLARIS is being integrated into clinical practice by hundreds of urologists in the United States and has been ordered more than 3,000 times in the past 12 months.
Key clinical characteristics of PROLARIS include:
- The PROLARIS Score® is the dominant variable at diagnosis in predicting risk of prostate cancer progression, as determined by the gold standard oncologic endpoints such as biochemical recurrence, metastasis and prostate cancer specific mortality;
- The PROLARIS Score provides personalized risk of cancer progression above that afforded by the Gleason score, clinical stage and PSA level; and
- PROLARIS helps clinicians identify patients who are good candidates for conservative management and patients for whom monotherapy with surgery or radiation therapy may be inadequate.
Myriad Is Trailblazing the Next Generation of Molecular Diagnostics for Cancer
Myriad Genetics is focused on answering patients' four key questions: What's my risk? Do I have disease? How aggressive is my disease? What therapy is best? Myriad is addressing these concerns by offering a range of products that assess risk of disease, ensure rapid and accurate diagnosis, predict disease progression and guide treatment decisions. Three pipeline candidates with the potential to transform diagnostic testing for cancer include myRisk™, myPath™ and homologous repair deficiency.
myRisk Hereditary Cancer™
Myriad recently announced its next-generation test for hereditary cancers called myRisk™ Hereditary Cancer. Myriad's myRisk represents a scientific advancement that will revolutionize hereditary cancer testing for appropriate patients. Initially, myRisk will include a 25-gene panel that is focused on clinically-actionable cancers including: breast, colon, ovarian, endometrial, pancreatic, prostate and melanoma. myRisk also will provide healthcare professionals and patients with an easy-to-understand, clinically-actionable report to help guide healthcare decisions and treatments. The company is collaborating with the medical and scientific communities and an early access launch is planned fall 2013.
myPath Melanoma is a molecular diagnostic test that evaluates gene expression targets to help dermatopathologists correctly assess difficult-to-diagnose skin biopsy samples. In the United States, more than two million skin biopsies for melanoma are performed annually and 14 percent are ruled indeterminate or uncertain. In these cases, patients and physicians are left with the challenging clinical decision of either potentially treating a patient with a benign condition or not treating a potentially deadly cancer. Myriad's myPath will differentiate melanoma from benign lesions and help physicians accurately diagnose this challenging cancer. Myriad anticipates presenting validation data and launching myPath in fiscal year 2014.
Homologous Repair Deficiency
Homologous Repair Deficiency (HRD) is the most accurate and comprehensive measure of deficiency in DNA repair processes. HRD has been extensively validated in triple negative breast cancer and ovarian cancer and is highly prevalent in other major cancers. Myriad is developing a diagnostic test based on HRD from a tumor sample that will enable healthcare providers to identify and treat patients based on their HRD status and use specific drugs targeted to the DNA repair pathways. The HRD test will be used as a companion diagnostic test along with therapeutics agents, and the company is on track to launch an HRD test for platinum-based therapies in 2015 and ADP ribose polymerase (PARP) inhibitors in 2017.
Myriad Collaborates Externally to Create Opportunities
In addition to the work in its own labs, Myriad is seeking out the best science through external collaborations and partnerships. Myriad recently announced a commercial partnership with its new homologous recombination deficiency test in patients being treated with Pharma Mar's PM1183 drug candidate and has an ongoing collaboration with AstraZeneca to develop a companion diagnostic for ovarian cancer.
Myriad also has research partnerships with numerous academic institutions and research centers including Johns Hopkins University, MD Anderson Cancer Center, Memorial Sloan Kettering Cancer Center, Queen Mary & Westfield College, University of Chicago, University Medical Center Hamburg-Eppendorf, and University of Edinburgh.
"Collaborations are vital to our research and development strategy," said Meldrum. "Our track record and commitment to scientific integrity and quality sets us apart from other diagnostic companies and has established Myriad as a preferred partner in molecular diagnostics."
Myriad Supports Education for Genetic Testing
Myriad invests millions of dollars annually to educate the public about cancer and diagnostic testing and to raise awareness of benefits of genetic testing. Examples of our educational programs include:
- Hereditary Cancer Quiz: www.myriad.com/patients/heredtiary-cancer-quiz/
- MySupport360: www.mysupport360.com/
- JustAsk! About HBOC: http://www.youtube.com/user/justaskhboc
- JustAsk! About Lynch: http://www.youtube.com/user/justasklynch
Myriad also supports education and advocacy through several national and local organizations such as Bright Pink, Cancer Wellness House, Colon Cancer Alliance, Fight Colorectal Cancer, Huntsman Cancer Institute, Living Beyond Breast Cancer, Lynch Syndrome International, National Ovarian Cancer Coalition and Sharsheret.
"We support increasing education and awareness about cancer and the benefits of molecular diagnostic testing," said Meldrum. "Our educational efforts are focused on helping patients better understand their risks and empowering them take control of their healthcare decisions."
Myriad Is Helping to Increase Patient Access
Myriad has helped thousands of patients gain access to molecular diagnostic testing through its Financial Assistance Program. Consistent with Myriad's long-held belief that genetic testing should be available to all eligible patients, the company provides free testing for people who do not have health insurance coverage and have an annual income of less than twice the poverty level. For more information about financial assistance visit: www.mysupport360.com/journey/financial-assistance.php
About Myriad Genetics
Myriad Genetics is a leading molecular diagnostic company dedicated to making a difference in patients' lives through the discovery and commercialization of transformative tests to assess a person's risk of developing disease, guide treatment decisions and assess risk of disease progression and recurrence. Myriad's portfolio of molecular diagnostic tests are based on an understanding of the role genes play in human disease and were developed with a commitment to improving an individual's decision making process for monitoring and treating disease. Myriad is focused on strategic directives to introduce new products, including companion diagnostics, as well as expanding internationally. 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, Melaris, TheraGuide, Prezeon, OnDose, Panexia and Prolaris are trademarks or registered trademarks of Myriad Genetics, Inc. in the United States and foreign countries. 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 presentation of data from five PROLARIS clinical studies in patients with prostate cancer at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago by Jack Cuzick, Ph. D, of Queen Mary College University of London; the key clinical characteristics of the PROLARIS test; the scope, launch and capabilities of three of the Company's pipeline candidate tests: myRisk, myPath and homologous repair deficiency; and the Company's strategic directives under the caption "About Myriad Genetics". These "forward-looking statements" are management's present 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 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 companion diagnostic services may decline or will not continue to increase at historical rates; risks related to changes in the governmental or private insurers reimbursement levels for our tests; the risk that we may be unable to develop or achieve commercial success for additional molecular diagnostic tests and companion diagnostic services in a timely manner, or at all; the risk that we may not successfully develop new markets for our molecular diagnostic tests and companion diagnostic 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 companion diagnostic 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; the development of competing tests and services; the risk that we or our licensors may be unable to protect the proprietary technologies underlying our tests; the risk of patent-infringement claims or challenges to the validity of our patents; risks of new, changing and competitive technologies and regulations in the United States and internationally; and other factors discussed under the heading "Risk Factors" contained in Item 1A in our most recent Annual Report on Form 10-K 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.