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Decipher Prostate Genomic Classifier

Decipher Prostate is a tissue-based genomic test that provides actionable information to help physicians and their patients make treatment decisions across the spectrum of localized prostate cancer.

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Decipher is the Most Validated Prostate Cancer Gene Expression Test

100,000+

Prostate cancer patients included in published studies with Decipher Prostate

25+

Phase 2 & 3 prospective randomized clinical trials that include Decipher Prostate

Incorporated as an integral biomarker in 7 National Cancer Institute-sponsored trials

70+

Decipher Prostate clinical validity &
utility publications

Decipher is the Only Prostate Cancer Gene Expression Test with Level 1 Evidence for Validation in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®)

Initial Risk Stratification for Clinically Localized Disease*
Category Tool Predictive Prognostic Endpoint
Trained Fora
Level of Evidence for Validationb
Gene
Expression
Testing
Decipher1 No Yes DM

DM = distant metastases

1
Prolaris2 No Yes See notec 3
Oncotype3 No Yes Adverse pathology 3

DM = distant metastases

“There are an extensive number of these tools created with substantial variability in quality of reporting and model design, endpoint selection, and quality and caliber of validation. It is recommended to use models that have high-quality and robust validation, ideally with randomized clinical trial data across multiple clinical trials.” PROS-D 2 of 4

  1. “Endpoint trained for” specifically related to what the biomarker or model was designed and optimized to predict. This is distinct from endpoints for which the biomarker has been shown to be prognostic in validation.
  2. Levels of evidence for biomarkers in this section are based on modified Simon et al criteria4.
    1. Validation in the context of multiple clinical trials with consistent results. Randomized trials are necessary for predictive biomarkers for validation.
    2. Validation in multiple independent prospective registry/observational cohorts with consistent results.
    3. Validation in multiple independent retrospective studies with consistent results.
    4. Validation in a single retrospective study, or multiple independent retrospective studies with inconsistent results.
  3. Prolaris is a composite of CAPRA and cell cycle progression (CCP) score. The derivation of CCP was based on genes involved in the cell cycle that were highly correlated and provided highly reproducible measurements of cell proliferation. Like other biomarkers it has been validated for multiple endpoints, but the test was not specifically trained for an endpoint a priori5.

References

1. Jairath, N. K. et al. Eur Urol 79, 374-383, (2021). 2. Sommariva, S. et al. Eur Urol 69, 107-115, (2016). 3. Covas Moschovas, M. et al. Eur Urol Focus 8, 418-424, (2022). 4. Simon, R. M. et al. J Natl Cancer Inst 101, 1446- 1452, (2009). 5. Cuzick, J. et al. Lancet Oncol 12, 245-255, (2011). * Adapted with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer V.1.2023.© 2022 National Comprehensive Cancer Network, Inc. All rights reserved. The NCCN Guidelines® and illustrations herein may not be reproduced in any form for any purpose without the express written permission of NCCN. To view the most recent and complete version of the NCCN Guidelines, go online to NCCN.org. The NCCN Guidelines are a work in progress that may be refined as often as new significant data becomes available. ** Based on data available from commercial websites as of March 8, 2023. Decipher Prostate is available as part of Veracyte’s CLIA-validated laboratory developed test (LDT) service. This test has not been cleared nor approved by the FDA.

Decipher Prostate Helps Address Key Clinical Questions Across the Spectrum of Localized Prostate Cancer

Clinical Uses of Decipher After Biopsy

Clinical Decision Decipher Risk May Consider
Active Surveillance Protocol Low Less Intense 1-6
High More Intense 1-6
Clinical Decision Decipher Risk May Consider
Active Surveillance OR Definitive Therapy Low Active Surveillance 1-6
High Definitive Therapy 1-6
Clinical Decision Decipher Risk May Consider
Radiation
OR Radiation + ADT
Low Radiation 1,4-7
High Radiation+ADT 1,4-8
Clinical Decision Decipher Risk May Consider
Duration of Hormone Therapy with Radiation Low Radiation + Short-Term ADT 6-8
High Radiation + Long-Term ADT 6-9

Clinical Uses of Decipher After Surgery

Decipher Prostate RP Genomic Classifier
Clinical Decision Decipher Risk May Consider
Monitoring Protocol Low Less Intense 10-12
High More Intense 10-12
Clinical Decision Decipher Risk May Consider
PSA Monitoring OR Treatment Low PSA Monitoring 10-12
High Treatment 10-12
Clinical Decision Decipher Risk May Consider
Radiation
OR Radiation + ADT
Low Radiation 13-15
High Radiation+ADT 13-15

Decipher Prostate was Developed to Predict Metastasis

  • Metastasis is the best surrogate endpoint for overall survival for prostate cancer.
  • Discovery and validation studies were completed in tumor tissue from a high-risk cohort of localized prostate cancer patients.
    20% of these patients developed distant metastases within 5 years.
  • Differential analysis of metastatic versus non-metastatic tumor RNA expression identified robust differences in the expression
    of the 22 genes that comprise the Decipher Prostate Genomic Classifier.

Tumor Registry
(1987-2001)
639 Post-RP Patents

Clinically High-Risk
(Gleason 8-10 or Pre-Op PSA
>20 ng/ML or ≥T3 or SM+)

Whole Transcriptome Microarray

RNA Expression of
22 genes across
7 cancer pathways

Genomic Risk of Metastasis

Well annotated tumor registry with long-term treatment & outcomes

Clinically high-risk RP cohort with 3 different outcomes: no PSA rise, PSA rise, distant metastasis within 5 years.

Compared tumor tissue from metastatic vs. non-metastatic patients & identified the 22 genes that comprise the Decipher Prostate Genomic Classifier

Decipher Prostate Resources

Decipher Prostate Requisition

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Frequently Asked Questions

How can I place an order?

Physicians can place an order by filling out a requisition and submitting the required forms using fax, email, or the Decipher portal. Visit our How to Order page to learn more.

How can I set up a portal account to begin ordering?

Please fill out a contact form here and a representative will reach out to help set up a portal account.

How can I contact a local representative to learn more?

Please fill out a contact form here to contact a representative to learn more about Decipher testing.

What is included in a patient’s Decipher Prostate test report?

The first page of the test report includes the patient’s Decipher Score, Decipher risk group (low, intermediate, or high), interpretation language, and risk estimates of prostate cancer specific outcomes. The second page contains more detailed information relevant to the specific patient. Click here to view the sample test report.

Is the Decipher Prostate Genomic Classifier or Decipher Bladder Genomic Classifier FDA cleared?  

The Decipher Prostate Genomic Classifier and the Decipher Bladder Genomic Classifier are available as part of Veracyte’s Clinical Laboratory Improvement Amendments (CLIA)-validated laboratory developed test (LDT) service. FDA approval or clearance is not required for the Decipher Prostate Genomic Classifier or Decipher Bladder Genomic Classifier.

Veracyte Labs SD, which performs Decipher testing is accredited/licensed by the following:

  • College of American Pathologists
  • Centers for Medicare and Medicaid Services (CMS) CLIA
  • California Department of Public Health
  • New York State Department of Health
  • Pennsylvania Department of Health
  • State of Rhode Island and Providence Plantations Department of Health Center for Health Facilities Regulation
  • Maryland Department of Health, Office of Health Care Quality
Can the Decipher Prostate Genomic Classifier or Decipher Bladder Genomic Classifier be ordered if I live outside the United States?

Currently, Decipher testing is only available within the United States. Decipher testing is available as part of Veracyte’s CLIA-validated laboratory developed test (LDT) service. Veracyte’s exclusive global access to the nCounter Analysis System for diagnostic testing will allow us to make our genomic classifiers – currently performed in our centralized labs for patients in the U.S. – available to physicians and their patients globally. We plan to adapt Decipher genomic testing to the nCounter Analysis System in the next few years. Feel free to fill out our contact us form should you be interested in Decipher testing outside the United States.

References

  1. Vince Jr, RA et al. Prostate Cancer Prostatic Dis (2021).
  2. Kim, HL et al. Prostate Cancer Prostatic Dis 22, 399-405 (2019).
  3. Herlemann, A et al. Prostate Cancer Prostatic Dis 23, 136-143 (2020).
  4. Berlin, A et al. Int J Radiat Oncol Biol Phys 103, 84-91 (2019).
  5. Spratt, DE et al. J Clin Oncol 36, 581-590 (2018).
  1. NCCN Guidelines® for Prostate Cancer v1.2023*
  2. Spratt, D. E. et al. J Clin Oncol 40, 269-269 (2022).
  3. Nguyen, PL et al. Prostate Cancer Prostatic Dis 20, 186-192 (2017).
  4. Nguyen, PL et al. Int J Radiat Oncol BIol Phys (2023).
  5. Den, RB et al. J Clin Oncol 33, 944-951 (2015).
  1. Ross, AE et al. Prostate Cancer Prostatic Dis 19, 277-282 (2016).
  2. Marascio, J et al. Prostate Cancer Prostatic Dis (2019).
  3. Feng, FY et al. JAMA Oncol 7(4): 544-552 (2021).
  4. Spratt, DE et al. Eur Urol 74, 107-114 (2018).
  5. Dal Pra A et al., Ann Oncol, 33(9); 950-958 (2022).

Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer V.1.2023. © National Comprehensive Cancer Network, Inc. 2022. All rights reserved. Accessed [June 5, 2023]. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. NCCN= National Comprehensive Cancer Network.

This page is intended for US healthcare professionals only.