Genomic Health Announces Publication of Oncotype DX® Prostate Cancer Test Decision Impact Study in Urology Practice, Supporting Wider Adoption and Reimbursement

Use of Test Significantly Impacts Treatment Recommendations for One in Four Men and Improves Confidence in 85 Percent of Physicians…

Genomic Health, Inc. announced that Urology Practice, an official journal of the American Urological Association (AUA), published positive results from the first decision impact study of the Oncotype DX® prostate cancer test. Results showed that use of the test substantially increased the number of men who can consider active surveillance, while increasing physician confidence in their treatment recommendations.

"By providing a way to refine risk assessment based on a patient's specific tumor biology, this genomic test allows physicians to confidently determine the best individualized treatment option for each man," said Ketan K. Badani, M.D., who led the study while at Columbia University, and who is currently vice chairman of Urology and Robotic Operations at Mount Sinai Health System, New York.

This prospective study involving 158 newly diagnosed prostate cancer patients showed that incorporation of the Genomic Prostate Score (GPS) changed modality and/or intensity of treatment recommendations in 26 percent of patients across multiple urology practice settings. The NCCN low risk group showed the greatest absolute recommendation change of 37 percent. The increase in recommendations for active surveillance was 24 percent. Additionally, 85 percent of urologists were more confident in their treatment recommendation following review of the GPS.

"These data underscore the significant impact that Oncotype DX has on treatment recommendations and suggest that use of our assay will decrease the burden of low-risk prostate cancer by helping physicians reduce unnecessary immediate treatment while helping identify those who would benefit from invasive treatment at diagnosis," said Phil Febbo, M.D., chief medical officer, Genomic Health. "We believe this publication, along with our second clinical utility study that has been accepted for publication, further strengthens our efforts to secure reimbursement."