The Decipher® Biopsy test provides better risk assessment for more individualized treatment for all patients diagnosed with localized prostate cancer at the time of biopsy.
Decipher Biopsy is intended for use in those patients who present with a very low, low, intermediate or high risk biopsy result according to NCCN Guidelines upon pathologic evaluation.
Decipher predicts the likelihood of clinically useful endpoints:
- High Grade Disease (Gleason Grade 4 or 5)
- 5 year metastasis
- 10 year prostate cancer death *
- Ross, A.E., et al., Tissue Based Genomics Augment Post-Prostatectomy Risk Stratification in a Natural History Cohort of Intermediate- and High-Risk Men. European Urology, 2015 Jan; 69(1): 157-65.
- Cooperberg, M.R., et al., Combined Value of Validated Clinical and Genomic Risk Stratification Tools for Predicting Prostate Cancer Mortality in a High-risk Prostatectomy Cohort. European Urology, 2015 Feb; 67(2): 326-333.
- Klein, E.A., et al., Decipher Genomic Classifier Measured on Prostate Biopsy Predicts Metastasis Risk. Urology, 2016; In Press.
- Knudsen, B.S., et al., Application of a Clinical Whole-Transcriptome Assay for Staging and Prognosis of Prostate Cancer Diagnosed in Needle Core Biopsy Specimens. Journal of Molecular Diagnostics, 2016; In Press.
The Decipher® Post-op test is intended to inform the management of high-risk men after radical prostatectomy.
Men with the following postoperative features are considered to be at high risk of disease recurrence following surgery, and are appropriate for Decipher:
|Medicare Indications||Additional Indications|
Current parameters used to guide postoperative treatment decision-making such as adverse pathology and PSA, lack the specificity to accurately guide treatment recommendations. Many patients with adverse pathology post-surgery never experience a PSA rise and many patients who do experience PSA rise, never develop metastatic disease 1, 2.
National Guidelines recognize the broad diversity in cancer. AUA, ASTRO and ASCO guidelines acknowledge radiotherapy candidates are at different risk levels for disease progression, and thus experience varying degrees of benefit from adjuvant radiotherapy3, 4. NCCN supports use of tumor-based molecular testing when determining risk for disease progression after surgery5,6
- Swanson, G.P. and J.W. Basler, Prognostic factors for failure after prostatectomy. J Cancer, 2011. 2: p. 1-19.
- Pound, C.R., et al., Natural history of progression after PSA elevation following radical prostatectomy. JAMA, 1999. 281(17): p. 1591-7.
- Thompson, I.M., et al., Adjuvant and Salvage Radiotherapy After Prostatectomy: AUA/ASTRO Guideline. J Urol, 2013. 190: p. 441-449.
- Freedland, S.J., et al., Adjuvant and Salvage Radiotherapy After Prostatectomy: American Society of Clinical Oncology Clinical Practice Guideline Endorsement. J Clin Oncol, 2014. 32(34): p.3892-8.
- NCCN. NCCN Clinical Guidelines in Oncology (NCCN Guideline). Prostate Cancer. Version 1. 2015. [cited 2014 October 24, 2014]; Available from: http://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf.p.3892-8
- Mohler, J.L, et al., Prostate Cancer, Version 1.20: Featured Updates to the NCCN Guidelines. JNCCN. 2016 Jan; 14(1): 19-30.
- ** Covered for Medicare patients whose physicians are registered in the Decipher CTR (Certification and Training Registry
- *** Not covered by Medicare. Prior authorization from insurance required.
Decipher Bladder Predicts Which Patients May Benefit from Neoadjuvant Chemotherapy Prior to Radical Cystectomy
Unmet Need : Which muscle invasive bladder cancer patients will benefit from neoadjuvant chemotherapy?
- Basal molecular subtype patients experienced ~30% survival benefit from NAC
- Luminal and Luminal Infiltrated molecular subtypes did NOT experience significant survival benefit from NAC
Decipher Bladder determines the molecular subtype with high accuracy for an individual patient tumor and informs which patients with muscle invasive bladder cancer may benefit from neoadjuvant chemotherapy.
Decipher Bladder Test Indications
- Specimen Type: TURBT (Transurethral Resection of Bladder Tumor)(FFPE)
- Tumor Type: Muscle Invasive Carcinoma
- Primary Histology Type: Urothelial/Transitional Cell Carcinoma
- No Evidence of Distant Metastasis
- No Prior Neoadjuvant Chemotherapy