Pediatric leukemia diagnostics software set for evaluation

Precision cancer diagnostics software developer Qlucore has initiated a performance evaluation study in Sweden and Denmark as a significant and crucial step towards obtaining a CE marked solution, with results from the study expected early in 2024.

The specific cancer to be tested in the study is acute lymphoblastic leukemia (BCP-ALL) which 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 intended use of the company’s software in the study is to qualitatively analyse genetic alterations that may cause the disease condition BCP-ALL, 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, the company said.

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