May 8, 2013
Genomic Health, Inc.
(Nasdaq: GHDX) is making its Oncotype DX® prostate cancer test available to physicians and their patients today following the presentation by the
University of California, San Francisco
(UCSF) of a positive clinical validation study at the 2013 American Urological Association (AUA) Annual Meeting in San Diego. Results showed that the test, developed in collaboration with UCSF and Cleveland Clinic, strongly predicted disease aggressiveness (p=0.002) offering information beyond currently available clinical factors, such as PSA and biopsy
, to help physicians and their prostate cancer patients confidently choose the most appropriate treatment based on an individualized risk assessment. Furthermore, this first-of-its-kind, multi-gene test has been validated to guide treatment decisions using the prostate needle biopsy sample taken before the prostate is removed -- thereby providing the opportunity for low risk patients to avoid invasive treatments such as radical prostatectomy or radiation.
"The results of our study showed that the individual biological information from the Oncotype DX prostate cancer test tripled the number of patients who can more confidently consider active surveillance and avoid unnecessary treatment and its potential side effects. The test also identified a smaller number of patients who, despite seemingly low-risk clinical factors, had more aggressive disease and, would suggest that they consider immediate treatment," said
, M.D., MPH, professor and chair, Department of Urology, UCSF and principal investigator of this validation study. "With these new study results, I believe we may be able to significantly increase the use of active surveillance, which has been limited to some extent by the absence of a validated genomic tool to more accurately distinguish low and high risk disease at the time of biopsy."
Active surveillance is a treatment plan that employs careful and consistent monitoring of the cancer in a man's prostate without removing it. Under active surveillance, patients have regular check-ups and periodic PSA blood tests, clinical exams and potential biopsies to closely monitor for signs of prostate cancer progression.