Clinical Evidence

Effective August 2, 2022, mdxhealth has acquired the Oncotype DX Genomic Prostate Score (GPS) test from Exact Sciences. Additionally, Exact Sciences will continue to perform the GPS test during the transition. Further communications explaining transition plans will be provided in the coming months. For more details, please review the press release.
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Low-Risk Data | High-Risk Data | Validation Studies

Measure what matters in your low-risk patients

The Oncotype DX Genomic Prostate Score® (GPS™) test includes the most robust definition of adverse pathology, which is a strong predictor of long-term endpoints.1

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A universal endpoint

Standard risk assessment tools for localized prostate cancer, such as biopsy, imaging, and PSA, can aid in assessing a patient’s risk of harboring adverse pathology or its components.

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A unique assay 

The GPS test is the only genomic test to provide the risk of adverse pathology as well as the risks of its components (pT3a+ and Gleason ≥ 4+3).5

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A useful definition

Extra prostatic extension (pT3a+ disease or higher) is included in the GPS assay’s definition of adverse pathology, which is important because it is a strong predictor of distant metastasis.2

Endpoints data

The presence of adverse pathology at radical prostatectomy (RP) is a near-term endpoint that's strongly prognostic for long-term outcomes.1

Patients who were found to have high-grade (Grade Group 3 or higher) or high-stage (pT3a+) disease at RP were at vastly higher risk of developing metastatic disease and dying of their prostate cancer than patients with favorable pathology, even out to 20 years after surgery.1

Outcomes data

The GPS test was associated with up to 20-year outcomes.3

Long-term data show the clinical utility of stratifying risk with the GPS test.3


20-year outcomes1,3

A study suggests that the GPS™ test may be prognostic for both distant metastasis and prostate cancer-specific mortality through 20 years after diagnosis, and that the GPS test together with clinical factors may improve risk assessment over clinical factors alone.1

Read the GPS Publication

In a large cohort of men with largely clinically low-risk prostate cancer treated with radical prostatectomy, the study suggests the presence of adverse surgical pathology significantly predicted 20-year risk of metastasis and prostate cancer-specific mortality. Patients with adverse pathology at radical prostatectomy had a 12-fold higher risk of metastasis than those with favorable pathology, demonstrating the value of this endpoint for assessing risk in this population.1 

Read the AP Publication



Measure what matters in your high-risk patients

The GPS test is clinically validated to answer key questions in the high-risk setting with endpoints that guide decision making.4,5

Graphic 10 years DM and PCD

 PROVIDES prognostic information about a patient’s individual risk of death and metastasis within 10 years of RP4,5 

The GPS test can help you determine the appropriate level of treatment by knowing the likelihood of disease progression.4,5



Endpoints data

The GPS test provides a score that is strongly predictive of adverse outcomes in high-risk patients.4,5
Likelihood of Disease Progression
New High Risk Patient Report is now available.

Precise risk assessment for informed treatment planning with the GPS cut point4

  • For patients with lower risk levels (≤40), monotherapy or minimization of combination therapy may be sufficient
  • For patients with higher risk levels (>40), a more aggressive therapy approach may be appropriate

Outcomes data

The GPS cut point is validated to stratify patients into categorical risk groups above and below 40 that are strongly associated with disease progression in clinically high risk patients.4

  • Patients with a GPS result of ≤40 had outcomes similar to those with favorable intermediate disease; patients with a result of >40 had outcomes resembling those with high-risk disease.4




Rigorous development and clinical validation

The Oncotype DX Genomic Prostate Score (GPS assay) was developed in collaboration with the Cleveland Clinic and the University of California, San Francisco (UCSF) to specifically address the many challenges inherent to prostate cancer risk assessment.6
The genes composing the Oncotype DX GPS test were chosen for their6:

  • Correlation with tumor aggressiveness regardless of multifocality or heterogeneity
  • Performance in biopsy samples with small tumor volume

Graphic 727 Prostate-specific Candidate Genes to 17 Genes


Androgen Signaling Cellular Organization Stromal Response Cellular Proliferation Reference

Over 9000 patients have been included in development studies, clinical validation studies, and clinical utility studies.6-23

Clinical validation studies

The clinical validation studies for the Oncotype DX GPS test were prospectively designed studies of archival tissue from a large, diverse set of data sources:

  •  Kaiser Permanente, Northern California (KPNC) (N=259)8
  •  University of California, San Francisco (UCSF) (N=395)6
  •  Center for Prostate Disease Research (CPDR) (N=402)7

A meta-analysis combining the UCSF and CPDR cohorts (N=732)24 provided more precise estimates for likelihood of adverse pathology.



See the benefits of integrating the test into your practice

The impact of the Oncotype DX GPS test on treatment planning has been demonstrated in multiple clinical utility studies.11,12

Prospective study
Assessed changes in urologists’ treatment recommendations pre- and post-Oncotype DX GPS test results. This decision-impact study demonstrated a 26% absolute change in management recommendations. Physician confidence improved in 85% of cases.11

Retrospective study
Compared 6-month management received in clinically low-risk patients with and without the Oncotype DX GPS test 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.12