Zurich-Schlieren, Switzerland, January 07, 2021 - The Proteomedix, the Swiss cancer diagnostics company, announced today that the results of PROPOSe, a prospective multicenter study of Proclarix® in clinical routine use, were published in European Urology Oncology.
Prostate specific antigen (PSA)-based detection of prostate cancer (PCa) often leads to negative biopsy results or detection of clinically insignificant PCa. The PROPOSe study was initiated to evaluate the accuracy of Proclarix, a novel blood-based diagnostic test to help in biopsy decision making. Ten clinical sites in Germany, Denmark and Austria prospectively enrolled 457 men presenting for prostate biopsy.
“This prospective study confirmed Proclarix performance as established during CE validation“, commented Dr. Ralph Schiess, CSO and co-founder of Proteomedix. Proclarix detected clinically significant cancer with high sensitivity above 90% and reliably ruled out patients with no or indolent cancer with a negative predictive value greater than 90%. When the biopsy performed was guided by MRI (magnetic resonance imaging), both sensitivity (97%) and NPV (96%) were even higher. Importantly, Proclarix was significantly superior to the current clinical standard percent free PSA in ruling out unneeded biopsies (22% vs. 14%) and the primary study endpoint was met (p-value < 0.005).
Prof. Dr. med. Thomas Steuber from the renowned Martini-Klinik Hamburg and principal investigator of the study stated: “In a routine use setting, Proclarix accurately discriminated clinically significant PCa from no or indolent PCa. This study provides strong support for the use of Proclarix in routine practice to improve the biopsy decision algorithm.”
Co-investigator Prof. Dr. med. Carsten Ohlmann from the Johanniter Krankenhaus Bonn added: “Proclarix is a novel blood-based test with the potential to accurately rule out no or insignificant cancer, and therefore to reduce the number of unneeded biopsies.”
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.
The multicentre PROspective Prostate biOmarker Study (PROPOSe) was initiated to confirm the diagnostic accuracy of Proclarix in everyday practice in subjects with a suspicion of PCa with an elevated PSA of 2-10 ng/ml, an enlarged prostate volume of ≥35 cm³, and a normal DRE result. Patients were recruited at 10 urology centres in Europe between August 2018 and December 2019. The study is registered with ClinicalTrials.gov (NCT03565289).
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