Evidence map›Paper›PMID 35810263›Full record

ArticleProstate cancer and prostatic diseases2022

Clinical use of the mRNA urinary biomarker SelectMDx test for prostate cancer.

Wieke C H Visser, Hans de Jong, Sandra Steyaert, Willem J G Melchers, Peter F A Mulders, Jack A Schalken

Open access · hybridAbstract read
In one paragraph

Article in Prostate cancer and prostatic diseases, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
3.5field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 23 citations in OpenAlex.

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  10. Biomarkers in Localized Prostate Cancer: From Diagnosis to Treatment.International journal of molecular sciences · 2025
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  18. Best of 2022 in prostate cancer and prostatic diseases.Prostate cancer and prostatic diseases · 2023
    Article
  19. Advancements in Biomarkers of Prostate Cancer: A Review.Technology in cancer research & treatment
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 2 institutions in 1 country.

Wieke C H VisserDepartment of Product Development, MDxHealth BV, Nijmegen, The Netherlands.
Hans de JongDepartment of Product Development, MDxHealth BV, Nijmegen, The Netherlands.ORCID 0000-0001-6559-6659
Sandra SteyaertDepartment of Computational Biology, Statistics and AI, VOF dobbio, Zelzate, Belgium.
Willem J G MelchersDepartment of Product Development, MDxHealth BV, Nijmegen, The Netherlands.
Peter F A MuldersDepartment of Urology, Radboud University Medical Centre, Nijmegen, The Netherlands.
Jack A SchalkenDepartment of Urology, Radboud University Medical Centre, Nijmegen, The Netherlands. Jack.Schalken@radboudumc.nl.ORCID 0000-0001-8274-7797
Radboud University Nijmegen · NLMDxHealth (Netherlands) · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMolecular biomarker tests are developed as diagnostic tools for prostate cancer (PCa) diagnosis. The SelectMDx (MDxHealth, Nijmegen, The Netherlands) test is a urinary-based biomarker test intended to be used to predict presence of high-grade PCa upon biopsy in men with elevated serum prostate-specific antigen (PSA) levels. Previous validation of the SelectMDx test revealed that 53% of the unnecessary biopsies (biopsies indicating no- or GG1 PCa) could be avoided using the SelectMDx test as a decision-tool to select men for prostate biopsy. The objective of this study is to examine the use of the commercially available SelectMDx test under routine, real-life practice.

methodsMen that underwent a SelectMDx test between May 2019 and December 2020 and that were originating from countries that perform the SelectMDx test on a regular basis were included in this study, resulting in 5157 cases from 10 European countries. Clinical parameters, urinary RNA scores, and test outcomes were compared between PSA groups, age groups, countries, and the validation cohort (described previously [4]) using the Mann-Whitney U test, Chi-Square test, Benjamini-Hochberg and Kruskal-Wallis tests.

results40.72% of the cases received a negative SelectMDx result. The test is also used in patients outside the intended-use population (PSA < 3 and >10 ng/mL). Clinical parameters (age, PSA density, DRE outcome) varied between patient population from individual countries and the validation cohort, resulting in differences in the potential number of saved biopsies using the test.

conclusionsThe potential number of reduced biopsies in clinical use was 40,72% using the SelectMDx test, assuming a negative SelectMDx test resulted in the decision not to biopsy the patient. This is higher compared to the validation cohort, which is explained by differences in patient population.

Indexed as

Prostatic NeoplasmsBiomarkers, TumorBiopsyHumansMaleProstateProstate-Specific AntigenRNA, MessengerBiomarkers, TumorProstate-Specific AntigenRNA, Messenger

Identifiers

PMID35810263
PMCPMC9385481
OpenAlexW4284977133

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.