Qlucore Diagnostics for Pediatric leukemia takes a Significant step closer to CE marking
-Qlucore Submits Technical Documentation to Notified Body
Qlucore, a leader in software development for precision cancer diagnostics, has taken the final major step in the process towards a CE-marked medical device for in-vitro diagnostics by submitting the technical documentation to a Notified Body. The CE marked product, Qlucore Diagnostics, is due to be launched in February 2025.
The targeted cancer disease is acute lymphoblastic leukemia (ALL) in children, a condition where mortality and treatment-related complications remain high.
In order for a medical device to be used in healthcare diagnostics, IVDR regulations require the device to have CE marking. The performance study initiated by Qlucore in December 2023 is now complete, with expected positive results. The technical documentation can now be reviewed and approved by the Notified Body. Qlucore has contracted BSI (British Standards Institute) as the Notified Body, and the Institute will conduct a formal review of the product's safety and performance. The result is regulatory approval and CE marking, and the estimated timeframe for regulatory approval of Qlucore Diagnostics BCP-ALL is February 2025.
The intended use of the software is to qualitatively analyze the genetic changes that may cause the disease condition BCP-ALL. This is done based on gene activity levels and the identification of gene fusions. The classification into genetic subgroups is performed using a machine learning-based classifier and subsequently, a probability is presented that indicates the likelihood that the patient belongs to one of six defined subgroups. *)
"Completing the performance study and having all technical documentation in place is the final major step. We now look forward to the approval that enables 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 intended customers are clinical laboratories in Europe.
*This is a simplified description of the planned use of the product. The exact usage will be determined in conjunction with regulatory approval.