NEW YORK – Swedish firm Qlucore said Friday that it has received CE marking under the EU's In Vitro Diagnostic Regulation for software that is used to aid the diagnosis and treatment of pediatric leukemia.
The firm said that B-cell precursor acute lymphoblastic leukemia (BCP-ALL) is the most common childhood cancer, and its Qlucore Diagnostics 1.0 for BCP-ALL software is the first CE-marked test under IVDR that is used to aid the diagnosis and treatment of pediatric acute leukemia. The software is used following RNA sequencing for the qualitative analysis of genetic alterations that are associated with BCP-ALL. It employs a machine learning-developed algorithm to identify the six most common BCP-ALL subtypes.
The results can be used for the subgrouping and management of patients with a BCP-ALL diagnosis, including the identification and ranking of gene fusions that are connected with disease development and response to treatment.
"By integrating advanced genetic analysis with user-friendly software, it is now possible to provide diagnostic laboratories and clinicians with a faster and more accurate diagnosis, ultimately improving outcomes for these children," Thoas Fioretos, a Lund University professor who collaborated on the development of the test, said in a statement.
Company officials said in 2023 that they aimed to secure IVDR certification for the test by February 2025, with tests for other cancer types to follow. On Friday, the firm said that it is developing other tests for lung cancer, acute myeloid leukemia, and bladder cancer.