Zurich-Schlieren, Switzerland, May 19, 2020. Proteomedix, the Swiss cancer diagnostics company announces today the publication of the analytical performance results of Proclarix, Proteomedix lead product for improved prostate cancer diagnostics in the peer-reviewed journal PLOS ONE.
The report published today highlights the analytical performance of the two CE-IVD assays that measure the cancer-related protein biomarkers thrombospondin-1 (THBS1) and cathepsin D (CTSD) in blood. THBS1 and CTSD, together with patient's age, total and free PSA, are integrated in a software algorithm to generate the Proclarix Risk Score. The Proclarix algorithm also corrects systematic PSA differences of third-party analyzers. The limit of detection, specificity, precision, linearity, interferences, and pre-analytical aspects were determined according to industry (CLSI) guidelines.
"Our novel commercial assays that are part of Proclarix are suitable for the use in routine clinical practice. THBS1 and CTSD can be accurately measured for their intended use independent of the lot and laboratory when conditions consistent with routine practice for PSA sampling and storage are used. This allows us to distribute Proclarix to any diagnostic laboratory and ensure the highest quality of the diagnostic results" said Ralph Schiess, CSO.
Christian Brühlmann, CBO added: "The excellent analytical performance data is an important piece in the puzzle and complements the multi-center clinical validation study with nearly 1,000 patients that was recently published in BJUI compass. We are excited that first laboratories offer Proclarix in Europe".
Proclarix® is CE marked, intended for in vitro diagnostic use 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 introduced to the market early 2020. Proteomedix is located in the Bio-Technopark of Schlieren, Switzerland. For more information, visit www.proteomedix.com.