Qlucore Passes Key Milestone Towards CE-Mark Registration for Qlucore Diagnostics: Technical Documentation Approved
Qlucore, a leading software development provider for precision cancer diagnostics, has entered the last and final stage of certification of a CE-marked medical device for in-vitro diagnostics. The technical documentation according to IVDR 2017/746 Annex IX Chapter II for Qlucore Diagnostics, is now approved by the notified body, BSI. The final stage involves obtaining certification for the quality management system. Having achieved approval of the technical documentation, the company is now significantly closer to bringing Qlucore Diagnostics to market.
The specific type of cancer being targeted for Qlucore Diagnostics is B-Cell Precursor Acute Lymphoblastic Leukemia (BCP-ALL) in children. This is a condition where mortality and treatment-related complications remain high. However, for a medical device to be utilized in healthcare diagnostics, IVDR regulations require the device to have a CE mark, a certification showing that the device has been assessed to meet high health, safety and environmental standards. This process was initiated by Qlucore AB last year. The performance study as well as the complete technical documentation have now been approved. The final stage of certification, to obtain acceptance of the quality management system, is well underway. The estimated timeframe for regulatory approval of Qlucore Diagnostics BCP-ALL is February 2025.
"The approval of all technical documentation is a major step. We now look forward to receiving this certification which will enable the launch of Qlucore Diagnostics for use in pediatric leukemia diagnostics. We are not aware of any other IVDR-approved software in this area." says Carl-Johan Ivarsson, CEO of Qlucore.
The software is intended for qualitatively analyzing the genetic changes that may lead to BCP-ALL. The analysis is based on gene activity levels and the identification of gene fusions. A machine learning-based classifier generates a probability score to determine the genetic sub-type of a tumor*. The results obtained from the Qlucore Diagnostics BCP-ALL can assist in the initial classification and management of pediatric patients with suspected or diagnosed BCP-ALL.
Qlucore diagnostics will be available to clinical laboratories across Europe.
*This is a simplified description of the planned use of the product. The exact usage will be determined in conjunction with regulatory approval.