Qlucore Diagnostics

Qlucore Diagnostics is a CE-marked IVDR software designed to provide RNA-seq based cancer diagnostics, focusing on Acute Lymphoblastic Leukemia (BCP-ALL). It facilitates the classification of gene expression subtypes in B-cell leukemias and supports gene fusion analysis.

The software employs a machine learning-based classifier with extensive subtype coverage, which minimizes the risk of costly and escalated treatments. It enhances the accuracy of subtype classification by correctly subtyping an additional 7% of samples, especially for identifying subtypes like DUX4-rearrangements and ETV6::RUNX1-like.

Key Features

• Subtype Classification: Integrates gene expression-based subtyping and gene fusions in a single report, providing comprehensive genetic insights.
• Robust Analysis: Utilizes up to three distinct gene fusion callers to ensure broad coverage, with fusions presented in tiers of clinical relevance.
• Cost Efficiency: Offers the potential to replace traditional Fish tests, leading to significant cost savings.
• Future-Ready: With Whole Transcriptome Sequencing (WTS), it allows for clinical annotation of all fusions, adaptable through software updates rather than lab changes.

Qlucore Diagnostics is specifically intended for the genetic workup of pediatric B-cell precursor Acute Lymphoblastic Leukemia using RNA-Seq data. It analyzes genetic subtypes such as BCR::ABL1, DUX4-rearranged, and others. The software's output, a detailed PDF report, includes conclusions, plots, and quality metrics for effective communication among clinicians, labs, and patients.

Clinical evaluations involved multi-site studies comparing the software results with known patient sample statuses, assessing sensitivity, specificity, and agreement rates.