GenomeDx Biosciences 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.

"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," said Doug Dolginow, M.D., Chief Executive Officer 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."

Our Decipher prostate cancer classifier tests are currently comprised of 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.

Studies of thousands of patients from leading cancer centers, published in multiple peer-reviewed journals, demonstrate that the Decipher tests can more accurately predict disease aggressiveness than traditional clinical measures, such as PSA and Gleason score.

Decipher Post-Op is covered by Medicare and by a number of private payors and preferred provider organizations representing, together with Medicare, about 70% of the approximately 66 million adult men in the United States age 40 or older who are at increased risk of being diagnosed with prostate cancer.