Qlucore Diagnostics for Paediatric leukaemia takes a Significant step closer to CE marking
January 31, 2024 – Drug Discovery – Qlucore, paediatric leukaemia
Qlucore submits technical documentation to notified body
31 January 2023 — Lund, Sweden — 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 leukaemia (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 analyse 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 paediatric leukaemia 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.
About Qlucore
Qlucore is a leading provider of new generation intuitive bioinformatics software for research and precision and companion diagnostics. Qlucore’s mission is to make it easier to analyse the huge amounts of complex data generated by innovations in the fields of genomics and proteomics by providing powerful visualisation-based bioinformatics data analysis tools for research and precision diagnostics. Qlucore Omics Explorer software is a easy to use bioinformatics software for research in the life science, plant and biotech industries, as well as in academia. Qlucore Diagnostics and Qlucore Insights are software platforms with built in AI-based machine learning for multi-omics companion and precision diagnostics. Qlucore was founded in 2007 in Lund, Sweden, and has customers in about 25 countries around the world, with sales offices in Europe and US, and distribution in several countries in Asia. Qlucore is listed on the Nasdaq First North Growth market. www.qlucore.com
