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Personalize and improve the early detection of aggressive prostate cancer

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1 in 9 men will develop prostate cancer in their lifetime. What is your risk of aggressive, potentially fatal prostate cancer?

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The molecular diagnosis solution offered by AMS Laborator Genetic addresses a significant medical need, unmet with timely and actionable information, that addresses the challenges of the current standard of care for diagnosing prostate cancer. The Select MDx test helps identify patients at high risk for aggressive prostate cancer, thus helping to select men for prostate biopsy.

SelectMDx,an urine test that helps identify men at risk for aggressive prostate cancer before the initial biopsy.

Test Panorama

SelectMDx helps doctors determine if a patient has a higher or lower risk of prostate cancer and which men can safely avoid the biopsy.

SelectMDx is a non-invasive urine test (liquid biopsy) that measures the expression of two biomarkers (mRNA for HOXC6 and DLX1 genes)1. The test provides binary results that, combined with the patient’s clinical risk factors, help the doctor determine if:

  • The patient may benefit from a biopsy and early diagnosis of prostate cancer, or
  • The patient can avoid biopsy and can be monitored through routine screening.
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Overcome the historical challenges of prostate cancer screening for a more effective and efficient diagnosis

Concerns about identifying patients with indolent prostate cancer and subsequent overtreatment have led to recommendations for the elimination of the PSA test. An increased 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 early detection of prostate cancer, leading to an increased likelihood of curative treatment. In contrast, delayed diagnosis can lead to poorer outcomes, lower quality of life, and higher healthcare costs.2

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SelectMDx increases your doctor's confidence in biopsy decisions

Included in the National Cancer Network Guidelines (NCCN).

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

The clinical utility of SelectMDx for prostate cancer is well established:

  • Men identified by the test as having a high probability of clinically significant cancer may be diagnosed and treated earlier after the biopsy, while men identified as being at very low risk may avoid the biopsy.
  • The negative predictive value (NPV) of the test is 95%, which means that if the test identifies a very low risk, the doctor and patient can be 95% sure that the patient does not have Gleason ≥7 (GS≥7) cancer and can avoid 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) version 2 computer.1, 3

References:
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.