“Genomic Health, Inc. (Nasdaq: GHDX) today announced the presentation of new results from a large multi-center validation study, which confirmed that the Oncotype DX® Genomic Prostate Score™ (GPS) is a strong independent predictor of metastases at 10 years in prostate cancer patients across all National Comprehensive Cancer Network (NCCN) clinical risk groups. The clinical validation study data were designated one of the ‘best posters’ (abstract #352) at the 32nd Annual European Association of Urology (EAU) Congress in London.”
“Genomic Health, Inc. (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.’ “
“Genomic Health, Inc. (GHDX) today announced topline results from a large clinical validation study of its biopsy-based Oncotype DX® Genomic Prostate Score™ (GPS). The study, performed in collaboration with a large integrated healthcare system, met its primary endpoint by demonstrating that the multi-gene OncotypeDX® test, assessed in prostate needle biopsy tumor tissue, is a strong predictor of the development of metastasis and prostate cancer death in patients with early-stage prostate cancer. With these new results, the Oncotype DX test becomes the first genomic test validated in all major short- and long-term end points: adverse pathology, biochemical recurrence, metastasis and prostate cancer-specific death.”
“Genomic Health, Inc. (Nasdaq: GHDX) today announced results from a study led by the University of California, San Francisco (UCSF) showing a broad distribution of Oncotype DX® Genomic Prostate Score (GPS) results among prostate MRI findings, suggesting that these two technologies may provide non-overlapping clinical information in men with localized prostate cancer.
” ‘For the first time, we looked at the association between information provided by a genomic assay and a prostate MRI to better understand the value these two technologies bring to clinical practice,’ said Michael Leapman, M.D., lead investigator from UCSF. ‘These new data show that, in some patients, further risk stratification may be possible, and tools such as GPS may add important biological information to more precisely assess the aggressiveness of a patient’s cancer.’
“In this study, researchers conducted a retrospective evaluation of the statistical association between the Oncotype DX GPS results and contributing gene groups with baseline endorectal MRI in 100 patients with clinically localized prostate cancer. The results showed a large variation of GPS results across MRI findings, demonstrating that Oncotype DX and MRI offer non-overlapping clinical insights in patients with early-stage prostate cancer.”
“According to the results from three studies published in European Urology, the 17-gene Oncotype DX Genomic Prostate Score is a significant predictor of disease aggressiveness at the time of diagnosis before intervention with radiation or surgery. The test provides more precise and individualized risk assessment than currently available tools and may help physicians choose the most appropriate treatment for their patients.”
Editor’s note: Newly diagnosed prostate cancer patients face complex treatment decisions based on many different factors. One major consideration is the level of aggressiveness of the cancer, i.e. how fast the cancer is likely to grow and metastasize. A test called the Oncotype DX Genomic Prostate Score examines 17 tumor genes to determine aggressiveness, and new research results show that the test is effective. Learn more about the test.