With diagnoses increasing by 6-10 percent a year in Europe, acute leukemia in children still experiences high mortality and treatment-related complications.

Selecting the optimal therapy is important. In response to this, the team at Rigshospitalet has implemented the use of Qlucore Insights for in-house use, in accordance with Article 5 (5) in EU IVDR, and included it in the RNA lab workflow. As data input whole RNA sequencing data (WTS) from diagnostic ALL samples are used.

The Qlucore Insights software, which is intended for research use only, has been validated for in-house use by the team at Rigshospitalet by comparing the results of RNA sequencing with standard methods such as G-band karyotyping, FISH, SNP array and RT-PCR. Forty-six B-ALL samples and 8 T-ALL samples from the biobank have been tested. Based on the validation results, RNA sequencing data analysis using Qlucore Insights is now incorporated as a routine diagnostic tool. 

“One thing that really stands out is the combination of a gene expression subtype classifier and the detection of gene fusions”, says Mette K. Andersen (MD, PhD) clinical geneticist at the Department of Clinical Genetics, Rigshospitalet. 
The case study is available for download at Qlucore.

Qlucore Insights is intended for research use. The software is provided to hospitals, clinics, and laboratories. 
A CE-marked version called Qlucore Diagnostics is currently under review for approval by a notified body.