The report published today in the peer-reviewed journal PLOS ONE 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.”
