GenomeDx Biosciences, San Diego, has launched 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 for use following surgery, to newly diagnosed patients at initial biopsy.
Decipher Biopsy assesses tumor aggressiveness across very low-, low-, intermediate-, and high-risk patients, enabling physicians to determine whether a patient may safely consider delaying initial local treatment, or 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. The study demonstrated the capability of the Decipher platform to use diagnostic prostate needle biopsies to predict the risk of high-grade disease and metastasis at 5 and 10 years following radical prostatectomy.1 Further, Decipher Biopsy was found to bring accuracy to men newly diagnosed with prostate cancer with an area under the curve, 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 under way 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,” says Eric Klein, MD, head of the Glickman Urological and Kidney Institute at Cleveland Clinic. “Decipher and the Genomic Resource Information Database (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.”
Doug Dolginow, MD, GenomeDx.
“Using the same genomic profile that has already been well validated for Decipher Post-Op, we are able to show similar superior results for a biopsy test across all stages of the disease spectrum,” says Doug Dolginow, MD, CEO of GenomeDx. “As our latest product from the Decipher GRID, Decipher Biopsy delivers critical information to both physicians and patients on tumor aggressiveness, offering valuable insight as to the appropriate course of treatment.”
GenomeDx’s line of Decipher prostate cancer classifier tests currently comprises Decipher Biopsy and Decipher Post-Op. These commercially available genomic tests provide an assessment of tumor aggressiveness based on the patient’s unique genomic profile. Decipher Biopsy is indicated for men after biopsy diagnosis, and Decipher Post-Op is indicated for men after prostate removal surgery. The Decipher tests are used by physicians to stratify patients into more accurate risk groups to better determine which patients will likely benefit from additional treatment and which will not, thereby enabling improved decision-making and helping low-risk patients avoid unnecessary treatments that have serious adverse side effects and result in unnecessary costs to the healthcare system.
For more information, visit GenomeDx Biosciences.
REFERENCE
- Klein EA, Haddad Z, Yousefi K, et al. Decipher genomic classifier measured on prostate biopsy predicts metastasis risk. Urology. 2016; published online in advance, January 22, 2016; doi: 10.1016/j.urology.2016.01.012.
