E!115503, RNAPCD, Qlucore AB

Purpose and goal:

Objectives achieved in the project include the implementation of the first-generation NSCLC classifier in Qlucore Insights, which enables full classification, visualisation and reporting of results for primary LUAD, LUSC or lung metastases originating from the breast, colon and kidney, as well as gene fusion presentation. The RNA-seq dataset was expanded to include additional lung metastases and lung nodules from inflammatory/infectious diseases (eg. tuberculosis).

The 2nd generation classifier was trained on 319 samples and achieved an overall accuracy of 0.9 probability. Expected results and effects:

We have achieved key technical objectives incl. the development of a classifier model to distinguish primary from metastatic tumours and to distinguish adenocarcinoma from squamous cell carcinoma. We are amplifying the impact of our project through: -Press release on the new model (28.5.23) -Meeting with cancer research groups at the Karolinska Institute (30.5.23)

-Participation in the meeting of the European Society of Human Genetics in Glasgow (9-11.6.2023) -Article published in Dagens PS (28.6.23) -Presenting results at the German Lung Research Centre in Munich (15-16.6.23) Approach and implementation: We have achieved all management and business objectives that include:

-Granted ethical approvals

-Established standard operating procedures for RNA extraction, RNA library preparation and RNA sequencing using the paired-end method -Established procedures for innovation, IP and risk management -Report on innovation management provided as input to updated business plan & go-to-market strategy.

Also, Qlucore has the complete design to obtain regulatory approval under the IVDR and contracted with a notified body the review of CE-mark documentation for the Qlucore Diagnostics.