Myriad publishes clinical utility study for Prolaris

March 6, 2014

Myriad Genetics, Inc., has published data from the PROCEDE 500 study in the journal Current Medical Research and Opinion, demonstrating that 65% 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.

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% of cases after receiving the Prolaris report. Forty percent of patients had a reduction in therapeutic burden, while 25% had an increase in therapeutic burden—independent of treatment strategy. The study also evaluated the shift in treatment paradigms from interventional to non-interventional and non-interventional to interventional.

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

Myriad also 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.