Myriad publishes clinical utility study for Prolaris®

SALT LAKE CITY, UT USA (Press Release) - March 3, 2014 -

Myriad Submits Updated Dossier for Medicare Reimbursement

Myriad Genetics, Inc. today announced that it has published data from the PROCEDE 500 study in the journal Current Medical Research and Opinion, demonstrating that 65 percent of physicians changed their original treatment plans for men with prostate cancer based on results from the Prolaris test. Prolaris is a 46-gene molecular diagnostic test that has been evaluated in 11 clinical studies with more than 5,000 patients.

“Prolaris is an absolute game changer for urologists because it adds meaningful new prognostic information in terms of risk assessment for prostate cancer patients that will improve their care,” said E. David Crawford, M.D., head of the Section of Urologic Oncology at the University of Colorado. “In this study, Prolaris led to major changes in therapies with significant reductions or increases in interventional treatments that were based on patients’ unique risk profiles.”

PROCEDE 500 is a prospective registry study that was designed to evaluate the impact of the Prolaris test on physician treatment recommendations for patients with prostate cancer. In this study of 305 patients, physicians said they would change their treatment plans in 65 percent of cases after receiving the Prolaris report – 40 percent of patients had a reduction in therapeutic burden, while 25 percent had an increase in therapeutic burden – independent of treatment strategy (i.e., surgery and/or radiation vs. active surveillance and/or watchful waiting). These results are summarized in Table-1 and Table-2 below:

Table –1: Reduction in Therapeutic Burden Among Trial Participants

Table – 2: Increase in Therapeutic Burden Among Trial Participants

The study also evaluated the shift in treatment paradigms from interventional to non-interventional and non-interventional to interventional. Those data appear in the Table-3 and Table-4 below:

Table – 3: Planned Interventional Therapy (e.g., Surgery and/or Radiation)

Table – 4: Planned Non-Interventional Therapy (e.g., Active Surveillance and/or Watchful Waiting)

Importantly, in this study there was an overall 50 percent reduction in surgical interventions and a 30 percent reduction in radiation treatment. Additionally, 96 percent of the 24 patients with initial “undecided” treatment regimens selected non-interventional options after receiving the Prolaris score. These results demonstrate that the Prolaris test is associated with high clinical utility among urologists.

“In multiple clinical studies, Prolaris was shown to provide personalized risk of cancer-specific death, metastases or biochemical failure beyond what is achievable with the Gleason score, clinical stage and PSA data,” said Michael Brawer, M.D. vice president of Medical Affairs at Myriad Genetic Laboratories. “PROCEDE 500 demonstrates that the Prolaris score significantly enhances treatment plans for men with localized prostate cancer.”

Myriad Submits Updated Clinical Dossier for Medicare Reimbursement

Myriad also announced that it has submitted the PROCEDE 500 data as part of the Prolaris clinical dossier to the Centers for Medicare & Medicaid Services (CMS) for Medicare reimbursement. As previously disclosed – based on the robust data set from 11 studies with more than 5,000 patients and six publications in peer-reviewed medical journals – the company expects a CMS coverage determination on Prolaris by the end of June 2014.

“More than 30,000 men will die from prostate cancer this year, so there is an urgent need to improve clinical care for patients,” said Brawer. “Prolaris adds real value to the healthcare system by reducing unnecessary surgeries or exposure to radiation for men at low risk, while increasing medical interventions for men with aggressive prostate cancer, which we believe will save and improve more lives and potentially save the healthcare system more money.”

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 prostate cancer patients. 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 surveillance and high gene expression is associated with a higher risk of disease progression in patients who may benefit from additional therapy. Prolaris has been proven to predict prostate cancer-specific disease progression in 11 clinical trials with more than 5,000 patients. For more information visit: www.prolaris.com.

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 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 and Prolaris, Myriad myPath Melanoma, Myriad myPlan Lung Cancer, Myriad myRisk Hereditary Cancer, are trademarks or registered trademarks of Myriad Genetics, Inc. in the United States and foreign countries. MYGN-F, MYGN-G.

¹An independent third-party audit identified greater than 80 percent concordance between the post-Prolaris testing treatment recommendation and the actual treatment received by the patients.

Myriad Genetics

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