Oncotype DX Genomic Prostate Score


Clinical Validation

Our test has been clinically validated, peer reviewed and included in major medical guidelines, proving the significance of our science for physicians and patients.

Patient-specific meta-analysis of two clinical validation studies to predict pathologic outcomes in prostate cancer using the 17-gene Genomic Prostate Score.
Brand TC, Zhang N, Crager MR, Maddala T, Dee A, Sesterhenn IA, Simko JP, Cooperberg MR, Srivastava S, Rosner IL, Chan JM, Febbo PG, Carroll PR, Cullen J, Lawrence HJ.
Urology. 2016; 89:69-75.

A 17-gene assay to predict prostate cancer aggressiveness in the context of Gleason grade heterogeneity, tumor multifocality, and biopsy undersampling
Klein EA, Cooperberg MR, Magi-Galluzzi C, Simko JP, Falzarano SM, Maddala T, Chan JM, Li J, Cowan JE, Tsiatis AC, Cherbavaz DB, Pelham RJ, Tenggara-Hunter I, Baehner FL, Knezevic D, Febbo PG, Shak S, Kattan MW, Lee M, Carroll PR.
Eur Urol. 2014;66(3):550-60.

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
Cullen J, Rosner IL, Brand TC, Zhang N, Tsiatis AC, Moncur J, Ali A, Chen Y, Knezevic D, Maddala T, Lawrence HJ, Febbo PG, Srivastava S, Sesterhenn IA, McLeod DG.
Eur Urol. 2014;68(1):123-31.

Decision Impact

Numerous studies from around the world consistently demonstrate that Oncotype DX changes physician treatment recommendations 30-40% of the time, underscoring its significant impact in clinical practice.

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
Badani KK, Kemeter MJ, Febbo PG, Lawrence HJ, Denes BS, Rothney MP, Rothberg MB, Brown GA.
Urology Practice. 2015;2(4):181-9.

Utility of the Oncotype DX prostate cancer assay in clinical practice for treatment selection in men newly diagnosed with prostate cancer (PCa): a retrospective chart review analysis
Dall'Era M, Maddala T, Polychronopoulos L, Gallagher JR, Febbo PG, Denes BS.
Urology Practice. 2015;2(6):343–8.

Clinical Validation:

Kaiser Permanente of Northern California assessed the association between GPS and two hard endpoints: metastasis and prostate cancer death in a cohort of 267 men.

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Clinical Validation:

The first validation study for Oncotype DX GPS analyzed needle biopsies from consecutive patients at the University of California San Francisco.

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Clinical Validation:

A confirmatory validation study at the Center for Prostate Disease Research included a relatively high proportion of African-American patients.

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