-Qlucore Submits Technical Documentation to Notified Body
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
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
The intended customers are clinical laboratories in
*This is a simplified description of the planned use of the product. The exact usage will be determined in conjunction with regulatory approval.
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