A non-invasive urine test to improve patient selection for initial biopsy.

SelectMDx 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”), SelectMDx 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

SelectMDx Increases Physician Confidence in Treatment Decisions

The clinical utility of SelectMDx 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

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

Clinical Validation Study

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.

Cost Effectiveness Study

SelectMDx Increases QALY and Cost Savings

Cost-Effectiveness of Urinary Biomarker Panel in Prostate Cancer Risk Assessment

Clinical Utility Study

Study Involving 418 Men Undergoing Evaluation for Initial Biopsy

SelectMDx Impacts Prostate Biopsy Decision Making in Routine Clinical Practice

Clinical Validation Study

Study of 144 Men Who Might Benefit from mpMRI

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

All Publications

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

Validation of a 2-Gene mRNA Urine Test for Detection of High-Grade Prostate Cancer in German Men

SelectMDx vs. Prostate Health Index in the Identification of High-Grade Prostate Cancer

Cost-Effectiveness of a 2-Gene Urine Biomarker Assay in MRI Strategies for the Initial Detection of Prostate Cancer

SelectMDx vs. Prostate Health Index in the Identification of High-Grade Prostate Cancer

References

1 1. Haese A, et al. (2019) Multicenter Optimization and Validation of a 2-Gene mRNA Urine Test for Detection of Clinically Significant Prostate Cancer before Initial Prostate Biopsy. J Urol. 2019 Aug;202(2):256-263

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

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