GenomeDx Biosciences Launches Decipher Biopsy Test

New Predictor of Prostate Cancer Disease Progression Now Available for Newly Diagnosed Patients

San Diego – March 8, 2016 – 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.”
“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.”

About Decipher® Prostate Cancer Classifier Tests

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.

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About Decipher GRIDTM

Our Decipher Genomics Resource Information Database (Decipher GRID) is a genomic data sharing platform that provides a foundation for open and interactive research collaboration and knowledge creation. Decipher GRID is a rapidly growing database that contains genomic profiles of thousands of patients, and constitutes what we believe to be the world’s largest shared, clinically-annotated genomic expression database in urologic oncology and one of the world’s largest global RNA expression databases utilizing cloud-based analytics. We believe Decipher GRID gives rise to new opportunities for information technology-enabled genomic solutions and enables more rapid discovery, development, commercialization and adoption of existing and new products. Through Decipher GRID, GenomeDx is building a suite of genomic tests to assist physicians and patients with clinical decision-making from disease screening through late-stage therapy.

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About GenomeDx Biosciences

GenomeDx Biosciences uses the power of collaborative genomics to transform the management and treatment of cancer patients. GenomeDx has built Decipher GRID, a large genomics database in urologic oncology that provides a foundation for open and interactive research collaboration and knowledge creation. Using Decipher GRID to analyze vast amounts of genomic data, GenomeDx develops and commercializes proprietary clinical tests that provide more accurate and useful diagnostic information than both traditional diagnostic tools and existing genomic tests. GenomeDx’s Decipher Post-Op and Decipher Biopsy are commercially available prostate cancer genomic tests that provide an assessment of tumor aggressiveness based on a patient’s unique genomic profile. GenomeDx is based in San Diego, California and Vancouver, British Columbia.

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Media Contact:

Ian Stone
Canale Communications