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Blood test to support challenging decision-making in prostate cancer

Proteomedix, the Swiss cancer diagnostics company, has announced that the results of PROPOSe, a prospective multicentre study of Proclarix in clinical routine use, have been 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 tumour. 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 (NPV) greater than 90%. When the biopsy performed was guided by magnetic resonance imaging (MRI), both sensitivity (97%) and NPV (96%) were even higher. Importantly, Proclarix was significantly superior to the current clinical standard, percentage  free PSA in ruling out unneeded biopsies (22% vs. 14%) and the primary study endpoint was met (P<0.005).

Professor 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 Professor 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.”

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Upcoming Events

Pathology Horizons 2024

MacDonald Bath Spa Hotel, Bath
18-20 April, 2024

Diagnostics North East Conference 2024

The Catalyst, Newcastle upon Tyne
19 April, 2024

ECCMID 2024 - European Congress of Clinical Microbiology and Infectious Diseases

Fira Gran Via, 08038 Barcelona, Spain
27-30 April 2024

British Society for Microbial Technology Annual Microbiology Conference

UK Health Security Agency, Colindale, London
2 May 2024

EQA Reports: Interpreting Key Information & Troubleshooting Tips

ONLINE - Zoom
Thursday 16th May 2024

Participants’ Meeting: UK NEQAS Immunology, Immunochemistry & Allergy

Sheffield Hallam University, City Campus, Howard Street, Sheffield
24th May 2024

Access the latest issue of Pathology In Practice on your mobile device together with an archive of back issues.

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