Zurich-Schlieren, Switzerland, October 18, 2022. Proteomedix, a Swiss diagnostics company committed to advance prostate cancer care, today announced that is has received IVDR certification for its prostate cancer diagnostic test Proclarix® from TÜV SÜD.
The new In Vitro Diagnostic Regulation (IVDR) recently replaced the IVD Directive. Under the IVDR, diagnostic products are categorized under a new system of one of four classifications from class A (low risk) to class D (highest risk). Proclarix as class C was assessed by TÜV SÜD for conformity resulting in IVDR certification.
“We are extremely proud about the certification of Proclarix under the new IVDR demonstrating compliance to the highest quality standard currently in force for tests used in screening, diagnosis, or staging of cancer,” said Ralph Schiess, CSO and co-founder of Proteomedix and added: “Offering Proclarix as one of the first IVDR compliant cancer tests demonstrates our commitment to highest analytical and clinical performance.”
As the regulatory landscape evolves toward a lifecycle approach that emphasizes risk management, Proteomedix incorporated the risk-based processes throughout its business by integrating risk management into its quality management system.
Martin Rhiel, Head of Quality and Regulatory Affairs at Proteomedix commented: “The IVDR requirements impact the entire IVD lifecycle, from development through clinical investigations and regulatory approval through post-market surveillance. IVD manufacturers must demonstrate proper technical documentation, conformity assessments, quality management requirements and post-market surveillance for ensuring continued safety and performance.
Proclarix® is CE-certified under IVDR 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.
About IVDR (In Vitro Diagnostic Regulation)
The new IVDR (Regulation (EU) 2017/746) replaces the EU’s IVDD (Directive 98/79/EC on in vitro diagnostic medical devices). It provides a harmonized regulatory framework to ensure the safety and performance of in vitro diagnostic devices. This regulation puts a greater responsibility on manufacturers to demonstrate that products have met the necessary requirements to be placed on the market, including conformity assessments by a Notified Body. Major impacts of the IVDR include greater transparency, extended scope, increased oversight, heightened traceability, stricter requirements, including the need for technical file remediation, as well as analytical performance and scientific validity. IVDR compliance is required for new products sold within the EU since May 2022.
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 currently available in Europe. Proteomedix is located in the Bio-Technopark of Zurich-Schlieren, Switzerland. For more information, visit www.proteomedix.com.
For further details, please contact:
Dr. Ralph Schiess, CSO
firstname.lastname@example.org, +41 44 733 40 90