A recent study has verified the analytical performance of Proclarix, a prostate cancer diagnostic from Proteomedix, Schlieren, Switzerland.1
The published report highlights the analytical performance of two CE-marked assays that measure the cancer-related protein biomarkers thrombospondin-1 (THBS1) and cathepsin D (CTSD) in blood. THBS1 and CTSD, together with the patient’s age and levels of total and free prostate-specific antigen (PSA), are integrated using a software algorithm to generate the Proclarix risk score.
The Proclarix algorithm automatically corrects for systematic differences in PSA levels resulting from the use of different third-party analyzers. Differences in the limit of detection, specificity, precision, linearity, interferences, and preanalytical aspects were determined and normalized according to industry guidelines.
“Our novel commercial assays that are part of Proclarix are suitable for use in routine clinical practice,” says Ralph Schiess, chief scientific officer at Proteomedix. “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.”
For more information, visit Proteomedix.
Reference
1. Macagno A, Athanasiou A, Wittig A, et al. Analytical performance of thrombospondin-1 and cathepsin D immunoassays part of a novel CE-IVD marked test as an aid in the diagnosis of prostate cancer. PLoS One. 2020;15(5):e0233442; doi: 10.1371/journal.pone.0233442.
