Zurich-Schlieren, Switzerland, March 10, 2022 - Proteomedix, a Swiss diagnostics company committed to advance prostate cancer care, today announced that the group of Prof. J Morote Robles from the Vall d’Hebron University Hospital in Barcelona, Spain published significant new clinical study results of Proclarix® in combination with MRI for improved prostate cancer diagnosis.
In the original study Morote et al. World J Mens Health (2021) showed that Proclarix can be used in a broad range of patients without the need for Digital Rectal Exam (DRE). Proclarix performed well in both the original, more specific indication in men with PSA 2 to 10 ng/ mL, prostate volume ≥35 mL, and normal DRE (n=281) or the total population (n=517). Net benefit of Proclarix existed in all men.
In addition, Morote et al. Eur Urol Open Sci (2022) published a sub-analysis of the original study specifically analyzing men with an indeterminate (PI-RADS 3) MRI result, a challenging scenario for the detection of clinically significant prostate cancer. The sub-study included 169 men (of the original 517 men) and Proclarix was more accurate in selecting appropriate candidates for prostate biopsy when compared to PSA density and the ERSPC MRI online risk calculator.
In the latest publication, Morote et al. Int J Biol Markers (2022) describe who with suspected prostate cancer can benefit from Proclarix after MRI and concluded that Proclarix outperformed PSA density in the selection of candidates for prostate biopsy, especially in men with PI-RADS 1-3.
Prof. Morote, principal investigator of the studies commented: “Proclarix proved to be effective before, after and together with multi parametric imaging to identify men at risk of clinically significant prostate cancer and those who can safely avoid biopsy.”
• The Efficacy of Proclarix to Select Appropriate Candidates for Magnetic Resonance Imaging and Derived Prostate Biopsies in Men with Suspected Prostate Cancer. Morote J, Campistol M, Celma A, Regis L, de Torres I, Semidey ME, Roche S, Mast R, Santamaría A, Planas J, Trilla E. World J Mens Health. 2021 Dec 27. doi: 10.5534/wjmh.210117.
• Improving the Early Detection of Clinically Significant Prostate Cancer in Men in the Challenging Prostate Imaging-Reporting and Data System 3 Category. Morote J, Campistol M, Triquell M, Celma A, Regis L, Torres I, Semidey ME, Mast R, Santamaría A, Planas J, Trilla E. European Urology Open Sci 2022;37:38–44. doi: 10.1016/j.euros.2021.12.009.
• Who with suspected prostate cancer can benefit from Proclarix after multiparametric magnetic resonance imaging? Morote J, Campistol M, Regis L, Celma A, Torres I, Semidey ME, Roche S, Mast R, Santamaría A, Planas J, Trilla E. Int J Biol Markers 2022 Feb 24; doi: 10.1177/03936155221081537.
Proclarix® is CE-IVD marked and indicated for prostate cancer diagnosis in patients with normal digital rectal exam (DRE), enlarged prostate volume and elevated levels of PSA at 2-10 ng/ml. Proclarix is a risk score combining in-vitro assays for the quantitative detection of biomarkers with a proprietary algorithm to assess a patient`s risk of having clinically significant prostate cancer. Detection of prostate cancer-related biomarkers in blood serum using the Proclarix risk score has been demonstrated in multiple clinical studies to be a reliable indicator of the presence of clinically significant prostate cancer.
Proteomedix is a healthcare company whose mission is to transform prostate cancer diagnosis. The company has identified novel biomarker signatures with utility in prostate cancer diagnosis, prognosis and therapy management. The lead product Proclarix® is a blood based prostate cancer test panel and risk score currently available in Europe. Proteomedix is located in the Bio-Technopark of Zurich-Schlieren, Switzerland. For more information, visit www.proteomedix.com.
For further details, please contact:
Dr. Ralph Schiess, CSO