Oncotype DX Genomic Prostate Score

About the Oncotype DX Genomic Prostate Score Assay

The Oncotype DX Genomic Prostate Score (GPS) assay is the only genomic assay designed for men with clinically low-risk cancer to help make treatment decisions at the time of diagnosis. The assay analyzes prostate cancer gene activity to predict disease aggressiveness.

The only genomic assay designed to help make treatment decisions at the time of diagnosis
It examines interactions among genes in the tumor to better understand the unique biology of the cancer—a science known as genomics for clinically low-risk prostate cancer patients (GS 3+3 and 3+4).

Essentially, the Oncotype DX GPS provides more specific and individualized information about prostate cancer aggressiveness. The assay:

  • Provides a result (GPS) ranging from 0-100 that corresponds to the biologic aggressiveness of the tumor.
  • Measures biology through the expression of 17 genes across four important genetic pathways and, in conjunction with clinical risk factors, predicts the likelihood of adverse pathology.

Multiple biologic pathways were more predictive than any single pathway alone2

Androgen Signaling Cellular Organization Stromal Response Cellular Proliferation Reference
AZGP1
FAM13C
KLK2
SRD5A2
FLNC
GSN
GSTM2
TPM2
BGN
COL1A1
SFRP4
TPX2 ARF1
ATP5E
CLTC
GPS1
PGK1

Developed and validated with studies

Learn more about Oncotype DX GPS development studies

The GPS assay was:

  • Developed based on multiple collaborative studies with the Cleveland Clinic to specifically address the many challenges inherent in prostate cancer risk assessment.1,2,3
  • Validated in two large, contemporary studies as a strong, independent predictor of adverse pathology at radical prostatectomy.2,4

See the benefits of integrating the test in your practice

The Oncotype DX GPS reveals the underlying tumor biology in clinically low-risk patients to provide actionable information for treatment or management planning.

Efficient treatment planning

The Oncotype DX GPS provides refined risk stratification, allowing you to more confidently recommend active surveillance or immediate treatment for your clinically low-risk patients. It has been demonstrated in two clinical utility studies to impact clinically meaningful changes in treatment planning across all clinically low-risk groups.5,6

Two clinical utility studies demonstrate how Oncotype DX GPS helps with treatment planning:

  • A prospective study assessed changes in urologists’ treatment recommendations pre- and post-Oncotype DX GPS results. This decision-impact study demonstrated a 26% absolute change in management recommendations. Physician confidence improved in 85% of cases.5
  • A retrospective study that compared 6-month management received in clinically low-risk patients with and without the Oncotype DX GPS results. This chart-review analysis revealed a 56% relative increase in the number of patients on active surveillance/watchful waiting at 6 months post-diagnosis when GPS testing was added to standard decision making tools.6

Explaining risk to patients

Oncotype DX GPS provides meaningful information on the aggressiveness of the tumor that, when combined with clinical pathologic features (PSA levels, Gleason score, anatomic stage, and NCCN® risk classification), helps when discussing management options with patients. The GPS report is a patient-friendly resource that facilitates discussions by consolidating key prostate cancer characteristics in a single document for ease of reference during management conversations.

Clear advantages for your patients

The Oncotype DX GPS assay has been developed and studied in over 4,000 patients.3 The results from the assay refine risk assessment, help guide treatment decisions, and potentially impact patient quality of life. For example, the results might give a low-risk patient the additional confidence he needs to pursue active surveillance, delaying or even completely avoiding the side effects of more aggressive treatment options like prostatectomy or radiation therapy.

REFERENCES

1. Knezevic et al. SUO. 2013.
2. Klein et al. Eur Urol. 2014.
3. Data on file. Genomic Health, Inc.
4. Cullen et al. Eur Urol. 2014.
5. Badani et al. Urol Pract. 2015.
6. Dall’Era et al. Urol Pract. 2015.

a. DOI: http://dx.doi.org/10.1016/j.juro.2017.02.637

National Comprehensive Cancer Network (NCCN) and NCCN are registered trademarks of NCCN. NCCN does not endorse any product or therapy.

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The Oncotype DX Genomic Prostate Score test predicts
both clinical risk and tumor aggressiveness.

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Clinical Validation:
KPNCa

Kaiser Permanente of Northern California assessed the association between GPS and two hard endpoints: metastases and prostate cancer death in a cohort of 6,184 men.

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