Proteomedix avoids unnecessary prostate biopsies with test

(CONNECT) Proteomedix, with its North American parent company Onconetix, has announced the publication of two peer-reviewed studies for its blood-based prostate cancer test Proclarix. The first publication is entitled Proclarix performance in excluding patients with no or indolent prostate cancer: evaluation in a Danish population. 373 existing serum samples from patients with suspected prostate cancer were re-examined with Proclarix. The percentage of men with clinically significant prostate cancer fell from 27 to 5 percent, with a sensitivity of 97 percent.

In an expanded population of 656 men, Proclarix was then used to analyze PSA density, i.e. the ratio of prostate-specific antigen (PSA) in serum to prostate volume. The Proclarix density also showed a significantly higher specificity than the PSA density with the same sensitivity. According to the press release, the study concluded for both populations studied that Proclarix reduces the number of prostate biopsies and the detection of clinically insignificant prostate cancer, while the risk of missing clinically significant disease remains low.

The second publication, entitled The prognostic value of Proclarix in prostate cancer patients on active surveillance: predicting transition to active therapy and disease progression in a Danish cohort, examined the prognostic value of the Proclarix risk score in men who had undergone active surveillance for low to intermediate risk prostate cancer. The study retrospectively analyzed serum samples taken from 132 men from the Danish PerPros prostate biobank.

The authors concluded that the Proclarix risk score can support clinical decision-making in the context of active surveillance by identifying patients at higher risk of progression and influencing the intensity of follow-up. "These results underline the potential of Proclarix for personalized prostate cancer treatment," concludes study leader Dr. AH Zedan.

For Proteomedix CEO Dr. Beat Rheiner, these two publications provide "important additional evidence of the broad clinical utility of Proclarix for the identification of healthy men who have been misclassified as positive and for the early detection of clinically significant prostate cancer." The Proclarix risk score had already previously shown a correlation with the aggressiveness of the tumor. It has now proven to be a "promising tool to support clinical decisions and personalized monitoring strategies for patients after diagnosis".

Proteomedix was founded in 2010 as a spin-off of the Swiss Federal Institute of Technology in Zurich and is located in the Bio-Technopark Schlieren-Zurich. ce/mm