Validation of a CE-IVD, urine exosomal RNA expression assay for risk assessment of prostate cancer prior to biopsy
Abstract Improved risk stratification of patients suspected of prostate cancer prior to biopsy continues to be an unmet clinical need. ExoDx Prostate (IntelliScore) “EPI” is a non-invasive urine test utilizing RNA from exosomes to provide a risk score that correlates with the likelihood of finding h...
| Main Authors: | , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Nature Portfolio
2022-03-01
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| Series: | Scientific Reports |
| Online Access: | https://doi.org/10.1038/s41598-022-08608-z |
| _version_ | 1811335459928801280 |
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| author | Alexander Kretschmer Holger Kajau Eric Margolis Ronald Tutrone Tobias Grimm Matthias Trottmann Christian Stief Georg Stoll Christian A. Fischer Claudia Flinspach Anja Albrecht Lisa Meyer Tina Priewasser Daniel Enderle Romy Müller Phillipp Torkler Jason Alter Johan Skog Mikkel Noerholm |
| author_facet | Alexander Kretschmer Holger Kajau Eric Margolis Ronald Tutrone Tobias Grimm Matthias Trottmann Christian Stief Georg Stoll Christian A. Fischer Claudia Flinspach Anja Albrecht Lisa Meyer Tina Priewasser Daniel Enderle Romy Müller Phillipp Torkler Jason Alter Johan Skog Mikkel Noerholm |
| author_sort | Alexander Kretschmer |
| collection | DOAJ |
| description | Abstract Improved risk stratification of patients suspected of prostate cancer prior to biopsy continues to be an unmet clinical need. ExoDx Prostate (IntelliScore) “EPI” is a non-invasive urine test utilizing RNA from exosomes to provide a risk score that correlates with the likelihood of finding high grade prostate cancer at biopsy. Here, we present the results from a prospective clinical validation study of EPI-CE, a CE-marked in-vitro diagnostic (IVD) assay, specifically developed for use in European clinical laboratories. The study (NCT04720599) enrolled patients with ≥ 50 years, PSA 2–10 ng/mL, prior to MRI, who were scheduled for initial biopsy. First catch urine samples were collected from participants without prior digital rectal examination or prostate massage. Exosomal RNA was isolated and expression levels of three biomarkers ERG, PCA3 and SPDEF were analyzed according to the EPI-CE Instructions For Use. In the study cohort of N = 109 patients, EPI-CE was validated to have a Negative Predictive Value of 89%, a Sensitivity of 92% and a superior performance to two commonly used multiparametric risk calculators (PCPT and ERSPC) in both Receiver Operating Characteristics with a higher Area Under the Curve for EPI-CE 0.67 (95% CI 0.56–0.77) versus PCPT 0.59 (95% CI 0.47–0.71) and ERSPC 0.60 (95% CI 0.49–0.72) and higher Net Benefits analysis across a wide range of risk acceptance levels. This is the first clinical study reporting on the performance of EPI-CE. We demonstrate that EPI-CE provides information beyond standard clinical parameters and provides a better risk assessment prior to MRI, of patients suspected of prostate cancer, than the commonly used multiparametric risk calculators. |
| first_indexed | 2024-04-13T17:24:33Z |
| format | Article |
| id | doaj.art-dbb36bbcee254de489ac3abbcaf618af |
| institution | Directory Open Access Journal |
| issn | 2045-2322 |
| language | English |
| last_indexed | 2024-04-13T17:24:33Z |
| publishDate | 2022-03-01 |
| publisher | Nature Portfolio |
| record_format | Article |
| series | Scientific Reports |
| spelling | doaj.art-dbb36bbcee254de489ac3abbcaf618af2022-12-22T02:37:51ZengNature PortfolioScientific Reports2045-23222022-03-011211710.1038/s41598-022-08608-zValidation of a CE-IVD, urine exosomal RNA expression assay for risk assessment of prostate cancer prior to biopsyAlexander Kretschmer0Holger Kajau1Eric Margolis2Ronald Tutrone3Tobias Grimm4Matthias Trottmann5Christian Stief6Georg Stoll7Christian A. Fischer8Claudia Flinspach9Anja Albrecht10Lisa Meyer11Tina Priewasser12Daniel Enderle13Romy Müller14Phillipp Torkler15Jason Alter16Johan Skog17Mikkel Noerholm18Ludwig-Maximilians University MunichSRH Wald-Klinikum Gera GmbHDepartment of Urology, Hackensack Meridian School of MedicineChesapeake Urology AssociatesUrologische Gemeinschaftspraxis KaufbeurenUrologie und Andrologie am PromenadeplatzLudwig-Maximilians University MunichExosome DiagnosticsExosome DiagnosticsExosome DiagnosticsExosome DiagnosticsExosome DiagnosticsExosome DiagnosticsExosome DiagnosticsExosome DiagnosticsExosome DiagnosticsExosome DiagnosticsExosome DiagnosticsExosome DiagnosticsAbstract Improved risk stratification of patients suspected of prostate cancer prior to biopsy continues to be an unmet clinical need. ExoDx Prostate (IntelliScore) “EPI” is a non-invasive urine test utilizing RNA from exosomes to provide a risk score that correlates with the likelihood of finding high grade prostate cancer at biopsy. Here, we present the results from a prospective clinical validation study of EPI-CE, a CE-marked in-vitro diagnostic (IVD) assay, specifically developed for use in European clinical laboratories. The study (NCT04720599) enrolled patients with ≥ 50 years, PSA 2–10 ng/mL, prior to MRI, who were scheduled for initial biopsy. First catch urine samples were collected from participants without prior digital rectal examination or prostate massage. Exosomal RNA was isolated and expression levels of three biomarkers ERG, PCA3 and SPDEF were analyzed according to the EPI-CE Instructions For Use. In the study cohort of N = 109 patients, EPI-CE was validated to have a Negative Predictive Value of 89%, a Sensitivity of 92% and a superior performance to two commonly used multiparametric risk calculators (PCPT and ERSPC) in both Receiver Operating Characteristics with a higher Area Under the Curve for EPI-CE 0.67 (95% CI 0.56–0.77) versus PCPT 0.59 (95% CI 0.47–0.71) and ERSPC 0.60 (95% CI 0.49–0.72) and higher Net Benefits analysis across a wide range of risk acceptance levels. This is the first clinical study reporting on the performance of EPI-CE. We demonstrate that EPI-CE provides information beyond standard clinical parameters and provides a better risk assessment prior to MRI, of patients suspected of prostate cancer, than the commonly used multiparametric risk calculators.https://doi.org/10.1038/s41598-022-08608-z |
| spellingShingle | Alexander Kretschmer Holger Kajau Eric Margolis Ronald Tutrone Tobias Grimm Matthias Trottmann Christian Stief Georg Stoll Christian A. Fischer Claudia Flinspach Anja Albrecht Lisa Meyer Tina Priewasser Daniel Enderle Romy Müller Phillipp Torkler Jason Alter Johan Skog Mikkel Noerholm Validation of a CE-IVD, urine exosomal RNA expression assay for risk assessment of prostate cancer prior to biopsy Scientific Reports |
| title | Validation of a CE-IVD, urine exosomal RNA expression assay for risk assessment of prostate cancer prior to biopsy |
| title_full | Validation of a CE-IVD, urine exosomal RNA expression assay for risk assessment of prostate cancer prior to biopsy |
| title_fullStr | Validation of a CE-IVD, urine exosomal RNA expression assay for risk assessment of prostate cancer prior to biopsy |
| title_full_unstemmed | Validation of a CE-IVD, urine exosomal RNA expression assay for risk assessment of prostate cancer prior to biopsy |
| title_short | Validation of a CE-IVD, urine exosomal RNA expression assay for risk assessment of prostate cancer prior to biopsy |
| title_sort | validation of a ce ivd urine exosomal rna expression assay for risk assessment of prostate cancer prior to biopsy |
| url | https://doi.org/10.1038/s41598-022-08608-z |
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