GenomeDx Biosciences, San Diego, has announced publication of the first prospective validation study for its Decipher prostate cancer classifier test, Decipher Post-Op, a genomic test used to improve clinical decisionmaking following radical prostatectomy.

In the study, Decipher Post-Op reclassified tumor aggressiveness in a large number of patients based on genomic risk assessment, as compared to traditional clinical and pathological risk assessment.1 The reclassifications have the potential to alter therapy decisions for patients following prostatectomy, by predicting whether an individual is at low, intermediate, or high risk of tumor metastasis.

Robert Den, MD, Thomas Jefferson University.

Robert Den, MD, Thomas Jefferson University.

“The delivery and timing of postoperative radiation therapy to treat prostate cancer continues to be controversial within the medical community because of ambiguity produced by traditional diagnostic tools,” says Robert Den, MD, associate professor of radiation oncology, cancer biology, and urology at Thomas Jefferson University, and lead author of the study. “Determining the right patient and the right time for postoperative radiation therapy is not straightforward. Patients and physicians have to balance the potential complications from radiation treatment with the risk of prostate cancer recurring.

“This study emphasizes the importance of utilizing a genomic classifier score, such as Decipher, to reclassify patients and better stratify postoperative therapy decisions, allowing for increased personalization of patient management,” Den adds.

The study included deidentified Decipher test results from 2,342 radical prostatectomy patients tested between January and September 2015. The samples were analyzed for genomic risk through Decipher, as well as clinically through CAPRA-S, a standard risk model used to evaluate cancer recurrence after surgery.

While Decipher correlated with baseline tumor characteristics for more than 2,000 patients, there was significant reclassification of tumor aggressiveness as compared to clinical parameters alone. Specifically, Decipher reclassified 52%, 76%, and 40% of patients in CAPRA-S low, intermediate, and high-risk groups, respectively, demonstrating that utilization of the Decipher genomic classifier can have major implications for the assessment of postoperative risk. Previous studies of Decipher have shown that it is highly accurate in detecting tumors with the greatest potential to metastasize, confirming the value of reclassifying patients’ risk based on genomic information and selecting therapy accordingly.

Doug Dolginow, MD, GenomeDx.

Doug Dolginow, MD, GenomeDx.

“This study demonstrates, in a robust cohort of patients, that the use of Decipher can provide both the patient and physician with a more accurate classification of low, intermediate, and high risk of tumor aggressiveness, compared to clinical measures alone,” says Doug Dolginow, MD, chief executive officer of GenomeDx. “We believe this will lead to more informed postoperative treatment recommendations and allow for better personalization of therapy.”

For more information, visit GenomeDx Biosciences.


  1. Den RB, Santiago-Jimenez M, Alter J, et al. Decipher correlation patterns post prostatectomy: initial experience from 2342 prospective patients. Prostate Cancer Prostatic Dis. Advance online publication August 30, 2016; doi: 10.1038/pcan.2016.38.