Swedish innovation evaluated for clinical diagnosis of pediatric leukemia

Qlucore, a leader in software development for precision cancer diagnostics, has taken a significant and crucial step towards obtaining a CE marked solution, initiating a formal performance evaluation study in Sweden and Denmark. Results from the study are expected early in 2024.

The specific cancer to be tested in the study is acute lymphoblastic leukemia (BCP-ALL) in children. Leukemia in children, i.e. BCP-ALL continues to have high mortality rates and treatment-related complications.

IVDR regulations for medical devices require products to be CE marked prior to use in healthcare diagnostics.

Once the ongoing performance evaluation study is completed, Qlucore will be required to compile a study report and create a technical file that will be submitted to a Notified Body. BSI (British Standards Institute) has been contracted as the Notified Body, and they will conduct the formal review regarding the product's safety and performance. The estimated timeframe for regulatory approval and CE marking of Qlucore Diagnostics BCP-ALL is February 2025.

The intended use of the software from Qlucore is to qualitatively analyze genetic alterations that may cause the disease condition BCP-ALL. This analysis is based on gene activity levels and the identification of gene fusions. Classification into genetic subgroups is performed using a machine learning-based classifier, which presents a probability of the patient belonging to one of six defined subgroups. *

"Entering this next phase of CE marking is a significant and important step for us," says Carl-Johan Ivarsson, CEO of Qlucore. “It indicates that our solution has reached a high level of maturity, and it is time to transition from internal testing to evaluation in a clinical setting. We look forward to the results that will determine the performance we can communicate.”

Intended customers are clinical laboratories in Europe, and exact usage will be determined in conjunction with regulatory approval.

*This is a simplified description of the intended use of the product. The exact form of use will be determined in connection with the regulatory approval.