Why a Genomic Test Like the Oncotype DX Genomic Prostate Score® (GPS) test?

Clinical features alone may not show the whole picture

Biopsy alone does not always accurately differentiate candidates for active surveillance.

GG = Grade group; GS = Gleason Score; RP = radical prostatectomy

~1 in 4 patients with a GS 6 at biopsy had more aggressive disease (GS >=7) at surgery1

~1 in 5 patients with a GS 7 at biopsy had less aggressive disease (GS 6) at surgery1

Biopsies often do not accurately categorize risk because of tumor heterogeneity, multifocality, and undersampling in prostate cancer.2

More accurate measures of tumor aggressiveness lead to more treatment decisions.

GENETIC VS GENOMIC

Genetic tests screen for inherited risk factors or spontaneously arising mutations. They can help identify the risk of getting cancer or how a tumor may respond to certain therapies.3

Genomic tests examine gene expression levels within a sample of tumor tissue. They provide information about the tumor’s biology and aggressiveness.3

What elevates the GPS™ test above other tests?

Tissue-based genomic assays vary in their validation data to predict long-term and short-term outcomes. They also differ in the ability of their results to help guide the active surveillance decision in low-risk and favorable intermediate-risk patients.

The only assay designed for critical treatment decisions in clinically low-risk, early-stage prostate cancer

Bring together biology, validation, and endpoint insights to soar above the competition:

*Studies performed in biopsy samples from clinically low risk and/or AS-candidate patient cohorts
**GPS Validation Studies

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  1. Brooks MA, Thomas L, Magi-Galluzzi C, et al. Validating the association of adverse pathology with distant metastasis and prostate cancer mortality 20-years after radical prostatectomy. Urol Oncol. 2022;40(3):104.e1-104.e7.
  2. Mehralivand S, Shih JH, Harmon S, et al. A grading system for the assessment of risk of extraprostatic extension of prostate cancer at multiparametric MRI. Radiology. 2019;290(3):709-719.
  3. Brooks MA, Thomas L, Magi-Galluzzi C, et al. GPS assay association with long-term cancer outcomes: twenty-year risk of distant metastasis and prostate cancer-specific mortality. JCO Precis Oncol. 2021;5:PO.20.00325.
  4. Cullen J, Kuo HC, Shan J, Lu R, Aboushwareb T, Van Den Eeden SK. The 17-gene genomic prostate score test as a predictor of outcomes in men with unfavorable intermediate risk prostate cancer. Urology. 2020;143:103-111.
  5. Data on file.
  6. Klein EA, Cooperberg MR, Magi-Galluzzi C, et al. A 17-gene assay to predict prostate cancer aggressiveness in the context of Gleason grade heterogeneity, tumor multifocality, and biopsy undersampling. Eur Urol. 2014;66(3):550-560.
  7. Cullen J, Rosner IL, Brand TC, et al. A biopsy-based 17-gene genomic prostate score predicts recurrence after radical prostatectomy and adverse surgical pathology in a racially diverse population of men with clinically low- and intermediate-risk prostate cancer. Eur Urol. 2015;68(1):123-131.
  8. Van Den Eeden SK, Lu R, Zhang N, et al. A biopsy-based 17-gene genomic prostate score as a predictor of metastases and prostate cancer death in surgically treated men with clinically localized disease. Eur Urol. 2018;73(1):129-138.
  9. Eggener S, Karsh LI, Richardson T, et al. A 17-gene panel for prediction of adverse prostate cancer pathologic features: prospective clinical validation and utility. Urology. 2019;126:76-82.
  10. Lin DW, Zheng Y, McKenney JK, et al. 17-gene genomic prostate score test results in the Canary Prostate Active Surveillance Study (PASS) cohort. J Clin Oncol. 2020;38(14):1549-1557.
  11. Badani KK, Kemeter MJ, Febbo PG, et al. The impact of a biopsy based 17-gene genomic prostate score on treatment recommendations in men with newly diagnosed clinically prostate cancer who are candidates for active surveillance. Urol Pract. 2015;2(4), 181-189.
  12. Dall’Era MA, Maddala T, Polychronopoulos L, Gallagher JR, Febbo PG, Denes BS. Utility of the Oncotype DX® prostate cancer assay in clinical practice for treatment selection in men newly diagnosed with prostate cancer: a retrospective chart review analysis. Urol Pract. 2015; 2(6), 343-348.
  13. Albala D, Kemeter MJ, Febbo PG, et al. Health economic impact and prospective clinical utility of Oncotype DX® Genomic Prostate Score. Rev Urol. 2016;18(3):123-132.
  14. Eure G, Germany R, Given R, et al. Use of a 17-gene prognostic assay in contemporary urologic practice: results of an interim analysis in an observational cohort. Urology. 2017;107:67-75.
  15. Lynch JA, Rothney MP, Salup RR, et al. Improving risk stratification among veterans diagnosed with prostate cancer: impact of the 17-gene prostate score assay. Am J Manag Care. 2018;24(1 Suppl):S4-S10.
  16. Leapman MS, Westphalen AC, Ameli N, et al. Association between a 17-gene genomic prostate score and multi-parametric prostate MRI in men with low and intermediate risk prostate cancer (PCa). PLoS One. 2017;12(10):e0185535.
  17. Kornberg Z, Cowan JE, Westphalen AC, et al. Genomic Prostate Score, PI-RADS™ version 2 and progression in men with prostate cancer on active surveillance. J Urol. 2019;201(2):300-307.
  18. Salmasi A, Said J, Shindel AW, et al. A 17-gene genomic prostate score assay provides independent information on adverse pathology in the setting of combined multiparametric magnetic resonance imaging fusion targeted and systematic prostate biopsy. J Urol. 2018;200(3):564-572.
  19. Magi-Galluzzi C, Isharwal S, Falzarano SM, et al. The 17-gene genomic prostate score assay predicts outcome after radical prostatectomy independent of PTEN status. Urology. 2018;121:132-138.
  20. Cullen J, Lynch JA, Klein EA, et al. Multicenter comparison of 17-gene genomic prostate score as a predictor of outcomes in African American and Caucasian American men with clinically localized prostate cancer. J Urol. 2021;205(4):1047-1054.
  21. Murphy AB, Carbunaru S, Nettey OS, et al. A 17-gene panel genomic prostate score has similar predictive accuracy for adverse pathology at radical prostatectomy in African American and European American men. Urology. 2020;142:166-173.
  22. Covas Moschovas M, Chew C, Bhat S, et al. Association between Oncotype DX genomic prostate score and adverse tumor pathology after radical prostatectomy. Eur Urol Focus. 2021;S2405-4569(21)00094-8.
  23. Aboushwareb T, Bennett J, Yuan Y, et al. Active surveillance or watchful waiting in clinically low-risk prostate cancer patients in the SEER database with and without an Oncotype Dx genomic prostate score assay. J Urol.2021;206(3S):e1094 (MP62-06).
  24. Brand TC, Zhang N, Crager MR, et al. Patient-specific meta-analysis of 2 clinical validation studies to predict pathologic outcomes in prostate cancer using the 17-gene genomic prostate score Urology. 2016;89:69-75.