Proteomedix, the Swiss cancer diagnostics company, announced today that Proclarix®, its blood-based test for prostate cancer diagnosis, has now been made commercially available in Europe. Proclarix combines proprietary biomarkers and a risk score that accurately identifies an individual patient’s risk for clinically significant prostate cancer.
The announcement of the launch follows a thorough clinical validation in which the convenient blood test, optimized for maximum sensitivity for prostate cancer, demonstrated an accuracy that is superior to any other in-vitro diagnostic method of prostate cancer diagnosis. The negative predictive value (NPV) of the test – a commonly used measure for the likelihood of actually not having cancer when a test is negative – was found to be 95% in a large study of 955 subjects collected from two different hospital cohorts evaluating its performance. In the same cohort the specificity was 43% versus 18% for percent free prostate specific antigen (PSA), the current gold-standard in prostate cancer detection. The results are about to be published (H. Klocker et al. (2020) Development and validation of a novel multivariate risk score to guide biopsy decision for the diagnosis of clinically significant prostate cancer BJUI Compass (in press)).
With this high level of performance, the new risk score provides a reliable and convenient method to complement PSA testing in prostate cancer diagnosis. Proclarix has the potential to significantly reduce the number of biopsies needed to detect clinically relevant prostate cancer.
"We are very excited to be able to start the commercialization of Proclarix," said Dr. Helge Lubenow, CEO of Proteomedix. "I would like to thank the team and our clinical partners for their commitment and hard work to make this happen. We look forward to making Proclarix available to physicians and laboratories throughout Europe."
According to the World Health Organization, there were about 450000 diagnosed cases of prostate cancer and over 105000 deaths from prostate cancer in 2018 in Europe. Prostate cancer remains the second-leading cause of cancer death in men in Europe.
Proclarix® is CE-IVD marked 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.
For further details, please contact:
Carolin Kutzki, Head of Marketing and Customer Support