San Diego, May 8, 2013 – GenomeDx Biosciences today announced the presentation of results of an independent validation study demonstrating that Decipher™ was a better predictor of clinical metastasis in prostate cancer patients treated with surgery than current risk assessment tools, including preoperative PSA levels, seminal vesicle invasion, extra capsular extension, surgical margins or Gleason score and nomograms. Decipher is a transformative genomic test that provides a readout of the risk of metastatic disease for individual men with prostate cancer following radical prostatectomy that is independent of PSA and other risk factors. The results of the study were featured in a podium presentation today at the 2013 American Urological Association Annual Meeting by R. Jeffrey Karnes, MD, a urologist at Mayo Clinic.
“As many as 50% of men are treated unnecessarily with radiation therapy after undergoing prostate surgery, risking permanent, life-altering side effects such as incontinence and erectile dysfunction,” said Doug Dolginow, MD, CEO of GenomeDx. “Only a small number of those patients actually develop life-threatening metastatic disease. If physicians could more accurately predict metastasis in men with prostate cancer, they could more effectively select patients for intensification of therapy.”
Decipher™‘s performance was validated in a blinded prospective case-cohort study of a population of 1,010 men at high risk of recurrence treated at the Mayo Clinic with radical prostatectomy between 2000 and 2006. Researchers randomly sampled 20% of the cohort plus all cases that developed metastasis and profiled radical prostatectomy samples with high-density microarrays. Decipher scores were generated for 219 patients. The primary endpoint was metastatic disease progression as confirmed by positive bone or CT scans. C-index, Cox modeling and decision curve analyses were used to compare the performance of Decipher to individual clinical variables.
The study found that the Decipher test improved prediction of metastasis when compared to clinical variables such as Gleason score, seminal vesicle invasion, extracapsular extension, positive surgical margins or PSA levels. In the study, 60% of patients tested had low Decipher scores, and, as a group, their incidence of metastatic disease 5 years after surgery was only 2.4%, less than half the risk of this population of high-risk men. For the 20% of patients tested that had high Decipher scores, the incidence of metastatic disease at 5 years was 23%, markedly higher than patients with low Decipher scores and nearly three times higher than the average risk of metastasis in this study, which was 6%. Multivariable modeling with clinical variables showed that Decipher was the only significant, independent predictor of metastasis (HR=1.51 for a 10% increase in Decipher score).
Decipher™ is a transformative prognostic test that provides a direct measure of the true biological risk of potentially lethal metastatic prostate cancer independently of PSA level and other risk factors. Decipher measures and analyzes the activity levels of multiple markers associated with aggressive prostate cancer to generate a patient’s tumor-specific risk of disease progression after surgery (radical prostatectomy). When used in conjunction with conventional risk assessment tools, validation data indicates that Decipher more accurately stratified a patient’s risk for developing metastatic cancer following radical prostatectomy.
Mayo Clinic has a financial interest in technology licensed to GenomeDx.
About GenomeDx Biosciences
GenomeDx Biosciences develops and commercializes genomic tests for prostate and other urologic cancers that have a real impact on treatment decision-making, improve patient outcomes and ultimately reduce healthcare costs. The company’s first test, Decipher™, is a transformative prognostic test that provides a direct measure of the true biological risk of metastatic prostate cancer independent of PSA and other risk factors. GenomeDx is based in San Diego, California and Vancouver, British Columbia. More information is available at www.genomedx.com.