GenomeDx Biosciences Launches Decipher Biopsy Test
March 8, 2016 – SAN DIEGO. GenomeDx Biosciences today announced the launch of Decipher Biopsy, a genomic test that evaluates RNA expression-based biomarkers to predict the risk of high-grade disease, metastasis and cancer-specific death at the time of biopsy in men with prostate cancer. The launch brings the Decipher Prostate Cancer Classifier, already clinically adopted and extensively validated following surgery, to newly diagnosed patients at initial biopsy. Decipher Biopsy is the only genomic test available to assess tumor aggressiveness across very low, low, intermediate, and high risk patients, enabling physicians to accurately determine if the patient may safely consider delaying initial local treatment or if he may benefit from earlier intensification of treatment with one or more therapies.
Of the almost 225,000 men diagnosed with prostate cancer in the United States each year, approximately 200,000 will have localized disease that qualifies them for Decipher Biopsy testing. The analytical and clinical validity of Decipher Biopsy has been demonstrated in three abstracts presented at medical meetings and a recently published peer-reviewed validation study conducted by Cleveland Clinic. That study, published online ahead of print by Urology, demonstrated the capability for the Decipher platform to use diagnostic prostate needle biopsies to predict the risk of high-grade disease and metastasis at five and 10 years following radical prostatectomy (RP). Further, Decipher Biopsy was found to bring superior accuracy to men newly diagnosed with prostate cancer with an area under the curve (AUC), a measure of test accuracy, of 0.80 alone and 0.88 when combined with traditional clinical risk measures. Multiple independent validation studies in more than 2,500 patients with very low, low, intermediate, and high risk disease are currently underway with the goal of further corroborating these findings and reinforcing the demonstrated performance of Decipher Biopsy.
“These findings demonstrate the ability of Decipher Biopsy to predict, with a high degree of accuracy, the likelihood of metastasis and other clinical endpoints across low, intermediate, and high risk patients at the time of biopsy,” said Eric Klein, M.D., Head of the Glickman Urological and Kidney Institute at Cleveland Clinic. “Decipher and GRID provide comprehensive assessment of tumor aggressiveness at a time when clinicians and patients are looking for information beyond standard clinical measures to help guide the optimal care for each patient.”
Source: GenomeDx Biosciences