In a press release issued yesterday, Genomic Health Inc. announced topline results from their clinical validation study of its biopsy-based Oncotype DX® Genomic Prostate Score™ (GPS).
The study met its primary endpoint by demonstrating that Oncotype DX® test is a strong predictor for the development of metastasis and also prostate cancer death in men with early-stage prostate cancer. The test evaluates the genetic makeup of tumor tissue taken from prostate biopsies.
The Oncotype DX test has now been validated for adverse pathology, biochemical recurrence, metastasis and prostate cancer-specific death.
According to a statement issued by Phil Febbo, M.D., the chief medical officer, Genomic Health, the validation included 21 clinical studies in more than 3,600 men.
The complete data analyses will be submitted at presentations at major urological meetings in 2017. Until then the data is not available for peer review.
The Oncotype DX GPS analyzes 17 genes across four biological pathways from tumor tissue removed during the biopsy. It provides an individual score that, in combination with other clinical factors, further clarifies a man’s risk prior to treatment intervention.