Genomic Health, Inc. announced the launch of its Oncotype DX® prostate cancer test which can differentiate low-risk and aggressive tumors with up to 95% accuracy. Applied to prostate needle biopsy samples, the test examines an individual patient’s 17 gene “signature”. The resulting Genomic Prostate Score (GPS), used in combination with a patient’s clinical characteristics, can help guide patients with low-risk disease towards active surveillance (i.e., watchful waiting) while patients identified as having an aggressive tumor can seek treatments like radical prostatectomy or radiation at an earlier, more advantageous point in time.
Results from a 395 patient validation study led by the University of California, San Francisco (UCSF) and six feasibility and development studies enrolling over 700 patients at the Cleveland Clinic were announced on May 8, 2013 at the American Urological Association (AUA) Annual Meeting in San Diego. Oncotype DX® proved to strongly predict disease aggressiveness (p=0.002) which in effect tripled the number of patients identified as appropriate candidates for active surveillance (from 5-10% to 26%). In contrast, treatment guidelines utilizing conventional classification methods alone lead to invasive treatment in 90% of patients with low-risk disease despite only a 3% chance of progression.
Genomic Health has previously released a Oncotype DX® breast cancer test to predict the likelihood of recurrence in ductal carcinoma in situ (DCIS) and a Oncotype DX® colon cancer test developed for the assessment of risk of recurrence in patients with stage II and stage III disease. The Prostate Cancer Foundation (PCF) and Safeway partnered to fund research instrumental in the development of the prostate cancer 17-gene predictive signature. The Oncotype DX® test is considered an In Vitro Diagnostic Multivariate Assay (IVDMIA) and as such, is not regulated by the U.S. Food and Drug Administration (FDA).