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Qlucore Hopes Pan-Cancer Classification Partnership Will Spur Growth in Precision Dx


CHICAGO – Qlucore spent much of 2021 repositioning itself to be a major player in precision diagnostics, just a year after expanding into precision medicine and software-based diagnostics with the introduction of its Qlucore Diagnostics platform.

Also in 2021, the firm introduced Qlucore Insights, a clinical data analysis software package that focuses on subtype classification and gene fusion analysis for research purposes.

The business expansion plan took a major step forward with an initial public offering on Nov. 5. Qlucore is now traded on the Nasdaq First North Growth Market, a division of Stockholm-based Nasdaq Nordic for smaller European companies. The Lund, Sweden-based firm had closed a SEK 30 million ($3.2 million) private placement in April 2021 as a precursor for that IPO.

The IPO was priced at SEK 55.00. Shares were trading at 30.40 SEK on Thursday.

In 2022, the company is executing its strategy of marketing Qlucore Insights and Qlucore Diagnostics for research use with an eye toward gaining CE marking for the latter, according to CEO Carl-Johan Ivarsson. He did not give a timetable for obtaining a CE mark. Qlucore Insights is a research-only product that does not need the designation, while the firm eventually wants to bring Qlucore Diagnostics into the clinical realm.

Ivarsson said that both Insights and Diagnostics are built on common architecture for a similar user interface, visualization, and reporting functionality. These products also have some commonality with the company's flagship Qlucore Omics Explorer data analysis system, which helps support organizations moving from research settings to companion diagnostics, according to the CEO.

"You can take … classification modules from the research tool and move them into the Qlucore Insights tool," Ivarsson said.

Qlucore is also creating plug-ins for each that customize the technology to different disease areas.

The firm has deployed a leukemia plug-in at Lund University and another for non-small-cell lung cancer at the Institute of Pathology at the University of Heidelberg, Germany. A third module for breast cancer does not have any announced users.

Qlucore also said last month that it will collaborate with Semmelweis University in Budapest, Hungary, to see if the partners can first create a gene expression-based classifier for leukemia and eventually translate it to other cancers, according to Ivarsson. In developing the model, the partners will use the Illumina TruSight RNA pan-cancer panel as well as Qlucore analytics and visualization technology.

The molecular onco-hematology research group in Semmelweis' Department of Pathology and Experimental Cancer Research is another early adopter of Qlucore Diagnostics. That university will use the technology to improve diagnostics of acute lymphoblastic leukemia through gene fusion analysis.

Ivarsson noted that Semmelweis will be working with cancer panels, while other early adopters of Qlucore Insights and Qlucore Diagnostics are involved in whole-genome transcriptomics and RNA-seq. That will help the firm test its software in a wider range of environments, he said.

At the time of the announcement, Csaba Bödör, head of Semmelweis University's onco-hematology molecular diagnostic laboratory, said that Qlucore Diagnostics will improve the process of gene fusion analysis thanks to the software's ability to create visualizations of RNA sequencing data from cancer samples.

Ivarsson said that Qlucore will combine its expertise in machine learning and visualization with the university's knowledge and competency in leukemia to build the pan-cancer classification model. The first phase of the collaboration will address clinical data in research settings, while a second potential phase could have the partners seeking regulatory approval to use the technology in "routine clinical applications," according to Ivarsson.

Much of the development of the pan-cancer classification model will be seen as experimental as Qlucore and Semmelweis look for ways to detect gene fusion from that data.

If the results work out, the company expects to extend the model to other customers, he said. Qlucore is not going to release results until the company and the university in this open-ended collaboration get it right, though Ivarsson said the company may bring on other partners to build this type of model.