Swedish bioinformatics software provider Qlucore AB (Nasdaq First North Growth Market:QCORE) on Friday introduced the first CE-marked diagnostic test for paediatric leukaemia under Europe's In Vitro Diagnostic Regulation (IVDR).

Now available for clinical use, Qlucore Diagnostics BCP-ALL is designed to enhance diagnostic accuracy, enabling more personalised treatment and improved patient outcomes.

The test, delivered as an AI-powered software solution, was developed in collaboration with Dr Thoas Fioretos and his team at Lund University. It uses RNA sequencing to analyse gene expression levels and classify patients into the six most common subtypes of B-cell precursor acute lymphoblastic leukemia (BCP-ALL).

By identifying genetic alterations and ranking gene fusions, the software aids in precise disease classification and treatment decisions. Sales of Qlucore Diagnostics 1.0 for BCP-ALL have commenced in Europe, with additional tests for lung cancer, acute myeloid leukemia and bladder cancer in development.

The CE mark, granted by the British Standards Institution, confirms compliance with European regulatory standards, allowing the test to be marketed and used across the European Economic Area. This certification reinforces confidence in the test's safety, reliability and clinical utility.