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

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.
Questions? Email: gps@mdxhealth.com

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:

		Decipher^® Prostate Biopsy	Prolaris^®
Genes selected based on performance in biopsy setting	^1,4	Genes selected to perform in radical prostatectomy specimens⁵	Genes selected based on correlation with cell cycle progression pathway⁶
Optimized for small prostate biopsy tissue samples	5 ng of RNA⁷	25-100 ng of RNA⁸	25-500 ng of RNA⁹
Predicts Adverse Pathology in AS candidate patient cohorts*	7 studies N¹=395 N⁴=402 N¹⁰=114 N¹¹=134 N¹²=749 N¹³=432 N¹⁴=215 Total N=2441**	2 studies N¹⁵=266 N¹⁶=647 Total N=913
Predicts pT3a+/Extra Prostatic Extension	¹²

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

References:
Gearman DJ, Morlacco A, Cheville JC, Rangel LJ, Karnes RJ. Comparison of pathological and oncologic outcomes of favorable risk Gleason Score 3 + 4 and low risk Gleason Score 6 prostate cancer: considerations for active surveillance. J Urol. 2018;199(5):1188-1195.

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.

National Human Genome Research Institute. Genetics vs genomics fact sheet. genome.gov. Updated September 7, 2021. Accessed May 5, 2022. https://www.genome.gov/about-genomics/fact-sheets/Genetics-vs-Genomics

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.

Erho N, Crisan A, Vergara IA, et al. Discovery and validation of a prostate cancer genomic classifier that predicts early metastasis following radical prostatectomy. PLoS One. 2013;8(6):e66855.

Cuzick J, Swanson GP, Fisher G, et al. Prognostic value of an RNA expression signature derived from cell cycle proliferation genes in patients with prostate cancer: a retrospective study. Lancet Oncol. 2011;12(3):245-255.

Knezevic D, Goddard AD, Natraj N, et al. Analytical validation of the Oncotype DX prostate cancer assay - a clinical RT-PCR assay optimized for prostate needle biopsies. BMC Genomics. 2013;14:690.

Klein EA, Haddad Z, Yousefi K, et al. Decipher genomic classifier measured on prostate biopsy predicts metastasis risk. Urology. 2016;90:148-152.

Warf M, Reid J, Brown K, Kimbrell H, Kolquist K, Stone S. Analytical validation of a cell cycle progression signature used as a prognostic marker in prostate cancer. 2015; J Mol Biomark Diagn, 5(239), 2.

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.

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.

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.

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.

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.

Kim HL, Li P, Huang HC, et al. Validation of the Decipher Test for predicting adverse pathology in candidates for prostate cancer active surveillance. Prostate Cancer Prostatic Dis. 2019;22(3):399-405.

Herlemann A, Huang HC, Alam R, et al. Decipher identifies men with otherwise clinically favorable-intermediate risk disease who may not be good candidates for active surveillance. Prostate Cancer Prostatic Dis. 2020;23(1):136-143.

Choose the GPS test to connect key insights for quick and actionable treatment decisions.

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

Clinical features alone may not show the whole picture

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

GENETIC VS GENOMIC

What elevates the GPS™ test above other tests?

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

Choose the GPS test to connect key insights for quick and actionable treatment decisions.

Quick Links

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

Clinical features alone may not show the whole picture

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

GENETIC VS GENOMIC

What elevates the GPS™ test above other tests?

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

Choose the GPS test to connect key insights for quick and actionable treatment decisions.

Quick Links

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