The first IVDR-approved commercial software solutions for AI-powered RNA-based companion and precision cancer diagnostics of acute myeloid leukaemia and bladder cancer

Introduction

Qlucore is developing visualisation-based analytical solutions with an established position in the next-generation sequencing (NGS) market. As pioneers in RNA-data analysis, we aim to revolutionise the field of companion and clinical diagnostics by developing software platforms integrating AI-powered machine-learning classification models for gene expression signatures and gene fusion analysis.

Future of Precision Oncology

By providing highly accurate and specific diagnoses, our platform represents the future of precision oncology, putting Europe at the forefront of AI-powered cancer classification. A software-based setup speeds up the introduction of new clinical guidelines and companion diagnostic solutions with the ultimate purpose of increasing survival rates and overall health.

Expansion Plans

We aim to cover all cancer types relevant for gene expression-based diagnostics, and then scale up into non-cancer indications, including:

• Cardiovascular diseases
• Neurological diseases
• Immunological disorders

Additionally, we plan to explore other data types, such as:

• Proteomics
• Single-cell RNA-seq

This approach will further disrupt the precision diagnostics industry.

Current Developments

Currently, we are preparing the solution with a classification model for B-cell progenitor acute lymphoblastic leukaemia (BCP-ALL) for the first IVDR certification (proof of concept). Building on those achievements and leveraging regulatory and data management experience, we will focus on acute myeloid leukaemia (AML) and bladder cancer (BC).

Specific Goals

For AML and BC, we will develop and CE-certify:

1. Classification models
2. Companion diagnostics (CDx)-specific classification models

Impact on European Genomics

The successful completion of this project will significantly improve Europe's position in genomics- and AI-based precision diagnostics and, as such, prompt similar initiatives across Europe. This will allow the EU to compete effectively with market leaders, particularly in the US, and offer significant benefits to patients diagnosed with cancer and society as a whole.