Myriad Genetics, Inc. (NASDAQ: MYGN) has announced that clinical data from three studies with Prolaris in prostate cancer patients were highlighted at the 2014 Society of Urologic Oncology (SUO) Annual Meeting hel in Rockville, Md. The new data show that the Prolaris test could save the healthcare system $6 billion over 10 years and that physicians are using the test appropriately to personalize treatment options for their patients.
“Improving patient care is our highest priority, and we strive to prevent the overtreatment of men with low-risk prostate cancer and the under treatment of high-risk patients,” said Michael Brawer, M.D., vice president of Medical Affairs, Myriad. “Based on the new data and our prior studies, it is clear that the Prolaris test improves health outcomes, reduces healthcare costs and aids physicians in providing clinical care for their patients.”
In a study that evaluated the economic impact of the Prolaris test, researchers found the test reduced costs by $2,850 per patient tested, which over a 10-year period could save the healthcare system $6 billion. For a health plan of approximately 30 million members, this would translate into more than $48 million in savings. It is estimated that two-thirds of these savings would be achieved in the first year after testing. The cost savings were driven by more use of active surveillance in low- and intermediate-risk patients and from lower disease progression rates in high-risk patients who received more extensive treatment.
The Company also will present interim results from PROCEDE 1000, which is the largest prospective clinical utility study to date that evaluates the impact of the Prolaris test on personalizing prostate cancer treatment. The interim data analysis of 816 patients demonstrated that physicians changed their treatment decisions in 44 percent of cases based on results from the Prolaris test. In 32 percent of patients, the Prolaris test score led to a reduction in treatment, while 12 percent of patients received more aggressive treatment based on their test score.
Additionally, the Company will present a clinical study that validates an active surveillance threshold for Prolaris in 585 conservatively managed men with localized prostate cancer. The clinical endpoint for the study was prostate cancer mortality. The results showed that there were no observed cancer deaths in patients who fell below the defined threshold. In a separate analysis of 1,718 patients from a commercial cohort, approximately 55 percent of the patients qualified for active surveillance based on the threshold.
“The validation of an active surveillance threshold will help us identify many more men who are good candidates for surveillance than appear to be based on their clinical features alone. For men considering deferred treatment, falling below the threshold will give them confidence that active surveillance is a realistic option instead of a more aggressive treatment,” said Brawer. “Prolaris is rapidly becoming the leading molecular prognostic test to determine if patients have aggressive prostate cancer or not and to help physicians personalize treatment decisions.”
2014 SUO – Poster Presentations
Title: Evaluation of the Economic Impact of the CCP Assay in Localized Prostate Cancer. Presenter: E. David Crawford
Title: Impact of CCP Test on Personalizing Treatment Decisions: Results from a Large Prospective Registry of Newly Diagnosed Prostate Cancer Patients. Presenter: Mark Gonzalgo
Title: Validation of an Active Surveillance Threshold for the CCP Score in Conservatively Managed Men with Localized Prostate Cancer. Presenter: Steven Stone
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 active surveillance and high gene expression is associated with a higher risk of disease progression in patients who may benefit from additional therapy.