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

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.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.

We aim to cover all cancer types relevant for gene expression-based diagnostics, and then scale up into non-cancer indications (e.g. cardiovascular and neurological diseases, immunological disorders) and other data types (e.g. proteomics and single-cell RNA-seq), further disrupting the precision diagnostics industry.

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, and progress, in the proposed project we will focus on acute myeloid leukaemia (AML) and bladder cancer (BC).

For AML and BC we will develop and CE-certify classification models and companion diagnostics (CDx)-specific classification models.

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 (in particular the US) and offer significant benefits to patients diagnosed with cancer and society as a whole.