Qlucore Diagnostics

Leading regulatory approved RNA-seq based molecular test 

Qlucore Diagnostics is a CE-marked IVDR software offering RNA-seq based cancer diagnostics. The first approved model is for Acute Lymphoblastic Leukemia (BCP-ALL). It includes both gene expression subtype classification of B-cell leukemias and gene fusion analysis support.​

Key benefits:

• Machine learning based subtype classification with enhanced subtype coverage. Reduces the risk of escalated and expensive treatments. An additional 7% of samples are correctly subtyped using gene expression profiles, enabling detection of DUX4-rearrangements and ETV6::RUNX1-like subtypes. See further details below.
• Simplified lab work. Combines gene expression-based subtyping and gene fusions in one report.
• Robustness. Utilizes up to three different gene fusion callers for improved coverage. Gene fusions are presented in Tiers including all detected fusions.
• Cost-effective. Qlucore Diagnostics can replace FISH tests with significant cost savings.
• Future proof. Whole Transcriptome Sequencing (WTS) allows all fusions to be clinically annotated, with future updates in software rather than in lab workflows.

Qlucore Diagnostics for Acute Lymphoblastic Leukemia (BCP-ALL) CE-marked

Qlucore Diagnostics BCP-ALL is a CE-marked IVDR software designed for the qualitative determination of clinically relevant genetic markers in samples from bone marrow or peripheral blood during the genetic workup of pediatric B-cell precursor Acute Lymphoblastic Leukemia (BCP-ALL). The software supports RNA-Seq data analysis using gene expression-based classification and gene fusion identification. Classification is achieved through a machine learning-based classifier, providing probability scores for the following genetic subtypes:

• BCR::ABL1 or BCR::ABL1-like
• DUX4-rearranged
• ETV6::RUNX1 or ETV6::RUNX1-like
• High hyperdiploidy
• KMT2A(MLL)-rearranged
• TCF3::PBX1 Gene fusion identification is performed by fusion callers, with identified gene fusions exported to a report along with fusion breakpoints. The gene fusions are organized in three tiers based on documented clinical relevance. All gene fusions matching quality criteria are included to enable additional information on novel gene fusions. The results aid in the initial classification and management of pediatric patients aged from one up to 18 years with suspected or diagnosed BCP-ALL. The Qlucore Diagnostics BCP-ALL is intended to be used with the Qlucore Diagnostics Platform software.

Clinical Performance

Clinical performance was evaluated on a representative sample of the intended population for the product in a multi-site study. Genetic subtype classification and gene fusion detection were performed by comparing the outcome of Qlucore Diagnostics BCP-ALL to the known status of the patient sample. The results of the clinical data were analyzed to produce sensitivity, specificity, percent positive agreement (PPA), percent negative agreement (PNA). The figure below presents the clinical performance for Qlucore Diagnostics BCP-ALL subtype classification.