REDWOOD CITY, Calif., Feb. 16, 2017 /PRNewswire/ -- Genomic Health, Inc. (NASDAQ: GHDX) announced today the presentation of results from four studies evaluating the clinical value and utility of its Oncotype DX® Genomic Prostate Score™ (GPS) in the management of early-stage prostate cancer. Collectively, these new data highlight the test's ability to predict disease aggressiveness and refine risk stratification across National Comprehensive Cancer Network (NCCN) clinical risk groups.
"We now have 22 clinical studies, involving more than 4,200 prostate cancer patients, that distinguish Oncotype DX as the only test developed specifically for men who are deciding between active surveillance or definitive treatment. The test is validated to provide individualized information about both the current state and future risk of patients' prostate cancer," said Phil Febbo, M.D., chief medical officer, Genomic Health. "Together with the recently published economic analysis demonstrating substantial cost savings of more than $2,200 per patient tested, the data presented will support increased adoption and reimbursement of Oncotype DX as physicians aim to bring precision medicine to their prostate cancer patients."
Kaiser Permanente Clinical Validation Study Confirms Oncotype DX GPS Predicts Biochemical Recurrence Across Full Spectrum of Prostate Cancer, Providing Improved Risk Stratification Beyond Clinical Risk Assessment

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A large clinical validation study, conducted in collaboration with Kaiser Permanente Northern California, has reconfirmed that the Oncotype DX GPS is a strong independent predictor of biochemical recurrence (BCR), a rise in prostate-specific antigen (PSA) in patients following surgery, which is a longer-term outcome measure of aggressive disease. To evaluate whether the GPS predicts BCR across the full spectrum of clinical risk as defined by NCCN criteria, researchers used Kaiser's database of 6,184 radical prostatectomy-treated men diagnosed with very low-, low-, intermediate- and high-risk prostate cancer. Results showed that the GPS was strongly associated with BCR both alone (p<0.0001) and after adjusting for PSA, clinical stage and central biopsy Gleason Score (p=0.002). The association between the GPS and BCR was similar within different racial groups and consistent with previously published findings from the study conducted in collaboration with the Center for Prostate Disease Research in 2014.