Physicians
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Included in the NCCN Guidelines for Prostate Cancer Early Detection.

Select mdx Helps Physicians Determine if a Patient is at Higher or Lower Risk for Prostate Cancer and Which Men Can Safely Avoid Biopsy

A non-invasive urine test (“liquid biopsy”), Select mdx measures the expression of two mRNA cancer-related biomarkers (HOXC6 and DLX1).1 The test provides binary results that, when combined with the patient’s clinical risk factors, help the physician determine whether:

  • The patient may benefit from a biopsy and early prostate detection, or
  • The patient can avoid a biopsy and return to routine screening

Overcomes Historical Prostate Cancer Screening Challenges for More Effective and Efficient Diagnosis

Concerns about identifying patients with indolent prostate cancer and subsequent overtreatment have led to recommendations for eliminating the PSA test. An elevated PSA result could be caused by factors other than cancer, including infection, inflammation or benign prostatic hyperplasia.

An elevated PSA is considered the best risk stratifier for the early detection of prostate cancer, resulting in an increased likelihood for curative treatment. In contrast, delayed diagnosis can lead to poorer outcomes, lower quality of life, and higher healthcare costs.2

Select mdx Increases Physician Confidence in Biopsy Decisions

Included in the National Comprehensive Cancer Network (NCCN) Guidelines
  • Biomarkers can improve the specificity of screening methods for clinically significant cancer.
  • Included in the 2020 NCCN Guidelines for Prostate Cancer Early Detection.

The clinical utility of Select mdx for Prostate Cancer is well-established:
  • Men identified by the test as having a high likelihood of clinically significant cancer can, upon biopsy, be diagnosed and treated sooner, while men identified at very low risk may avoid biopsy.
  • The test’s negative predictive value (NPV) is 95%, meaning if the test identifies a very low risk, the physician and patient can be 95% sure the patient does not have Gleason score ≥7 (GS≥7) prostate cancer and avoid a biopsy.1,3
  • The test has a very high predictive accuracy (AUC 0.85) for high-grade prostate cancer, which is significantly better than the Prostate Cancer Prevention Trial (PCPT) risk calculator version 2.1,3

 

Mdxhealth is regulated under the Clinical Laboratory Improvement Amendments (CLIA) and College of American Pathologists (CAP) as an accredited laboratory to perform high complexity clinical testing. The Select mdx for Prostate Cancer test was developed, and its performance characteristics determined by mdxhealth. It has not been reviewed by the U.S. Food and Drug Administration. The FDA has determined such clearance or approval is not necessary. The test is intended for use as an aid to clinicians for patient management decisions about the need for a prostate biopsy in men with clinical risk factors suggesting an increased risk for prostate cancer. Use outside of this indication has not been validated by mdxhealth. Test results should be interpreted in conjunction with other laboratory and clinical data available to the clinician and relevant guidelines on the decision for biopsy. CLIA# 05D2033858; CAP# 8015399

Numerous Studies Verify the Test’s Validation, Clinical Utility and Cost Savings

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Multicenter Study of 1,955 Men
Multicenter Optimization and Validation of a 2-Gene mRNA Urine Test for Detection of Clinically Significant Prostate Cancer Prior to Initial Prostate Biopsy.
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SelectMDx Increases QALY and Cost Savings
Cost-Effectiveness of Urinary Biomarker Panel in Prostate Cancer Risk Assessment
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Study Involving 418 Men Undergoing Evaluation for Initial Biopsy
SelectMDx Impacts Prostate Biopsy Decision Making in Routine Clinical Practice
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Assessment of an Established TRUS and a Urinary Biomarker-Based Risk Score as an Inclusion Criteria for Multiparametric MRI to Detect Clinically Significant Prostate Cancer
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Clinical, Analytical, Cost Effectiveness Studies

1 Haese, A, et al. (2019) Multicenter Optimization and Validation of a 2-Gene mRNA Urine Test for Detection of Clinically Significant Prostate Cancer Prior to Initial Prostate Biopsy. J Uro. doi: 10.1097/JU.0000000000000293

2 Govers TM, et al. (2018) Cost-Effectiveness of Urinary Biomarker Panel in Prostate Cancer Risk Assessment. J Urol. doi:  10.1016/j.juro.2018.07.034

3 Govers TM, et al. Cost-effectiveness of SelectMDx for prostate cancer in four European countries: a comparative modeling study. Prostate Cancer and Prostatic Diseases. doi: 10.1038/s41391-018-0076-3

4 Trooskens G, et al. (2018) Robust performance of a Urinary Molecular Biomarker–Based Risk Score to detect High-grade Prostate Cancer using optimized cascading models. In: Global Congress on Prostate Cancer; 2018 Jun 28-30; Frankfurt, Germany.

5 Shore N, et al. (2018) SelectMDx Impacts Prostate Biopsy Decision-making in Routine Clinical Practice. Urology Practice. doi: 10.1016/j.urpr.2018.09.002.

6 Trooskens G, et al. (2018) Assessment of an established TRUS and a urinary biomarker-based risk score as an inclusion criteria for multiparametric MRI to detect clinically significant prostate cancer. In: Global Congress on Prostate Cancer; 2018 Jun 28-30; Frankfurt, Germany.

7 Van Neste L, et al. (2016) Detection of High-grade Prostate Cancer Using a Urinary Molecular Biomarker-Based Risk Score. Eur Urol, Nov; 70(5): 7 40-7 48.

8 Hendriks RJ, et al. (2017) A urinary biomarker-based risk score correlates with multiparametric MRI for prostate cancer detection. The Prostate, 77(14):1401-1407.

9 Hessels D, et al. (2017) Analytical validation of an mRNA-based urine test to predict the presence of high-grade prostate cancer. Translational Medicine Communications, 2:5. doi: 10.1186/ s41231-017-0014-8.

10 Dijkstra S, et al. (2017) Cost-effectiveness of a new urinary biomarker-based risk score compared to standard of care in prostate cancer diagnostics – a decision analytical model. BJU Int, 120(5):659-665. doi: 10.1111 /bju.13861.

11 Alinezhad S, et al. (2016) Validation of Novel Biomarkers for Prostate Cancer Progression by the Combination of Bioinformatics, Clinical and Functional Studies. PLoS ONE, 11 (5): e0155go1. doi: 10.1371/journal.pone.0155901.

12 Leyten GH, et al. (2015) Identification of a Candidate Gene Panel for the Early Diagnosis of Prostate Cancer. Clin Cancer Res, 21 (13):3061-70.

13 Vinarskaja A, et al. (2011) DNA Methylation and the HOXC6 Paradox in Prostate Cancer. Cancers, 3:3714-3725. doi: 10.3390/cancers3043714.

Posters & Abstracts

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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.

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