NEW YORK – Swedish bioinformatics technology developer Qlucore is working toward securing European Union In Vitro Diagnostic Regulation (IVDR) certification for its diagnostics software for acute lymphoblastic leukemia (ALL) testing, targeting February 2025. This will be followed by tests for other cancer types that the firm will seek regulatory approval for.
IVDR certification of software requires evaluation of the product's clinical performance, quality management, and cybersecurity, as well as the assignment of a unique device identification code. While it is unclear how far along Qlucore is with the certification process at this time, the Lund, Sweden-based company announced late last month that it had won a grant worth SEK 200,000 ($18,275) from the Swedish Agency for Innovation Systems — known as Vinnova — through the country's Medtech4Health program to enhance data security for its software, called Qlucore Diagnostics.
Qlucore had already successfully completed data security tests as part of the IVDR certification process prior to receiving the grant, though, according to CEO Carl-Johan Ivarsson.
IVDR, which started being implemented in May 2022, aligns the European Union's IVD regulatory process more closely with that of the US by requiring the clearance of most tests and diagnostic software by designated certification organizations, called notified bodies, before they can be sold for clinical use. Qlucore said it has engaged the British Standards Institution as the notified body for its application.
The 2020 launch of Qlucore Diagnostics represented the firm's first foray into precision medicine and software-based diagnostics, though it is not currently authorized for diagnostic use. While the firm originally introduced the software for the analysis of RNA-seq tests for leukemia, it has always had plans to expand it into non-small cell lung cancer, according to Ivarsson.
Another Vinnova grant, awarded in 2020, supported the building of RNA profiling models for acute leukemia as well as for glioma on the Qlucore Diagnostics software platform.
Qlucore Diagnostics builds upon the firm's Qlucore Omics Explorer data analysis system to support analysis and visualization of fusion genes. The company has said since the beginning that future versions of Qlucore Diagnostics would include classifiers to help pathologists and oncologists apply gene expression signatures to classify biological samples into disease subgroups.
Qlucore Diagnostics crosses over between the data analytics and precision and companion diagnostics divisions of the company. It complements the firm's other software product in precision medicine, Qlucore Insights, which was designed for research purposes only. Qlucore Insights now has cancer subtyping models for ALL, acute myeloid leukemia (AML), lung cancer, and bladder cancer.
While the firm will initially only seek IVDR certification of Qlucore Diagnostics for ALL, Qlucore said last month that it is continuing to "develop and refine" diagnostic models for lung cancer, bladder cancer, ALL, and adult AML.
With the target date for IVDR recognition nearly a year and a half off, Ivarsson said that Qlucore will communicate further progress toward the goal as the firm meets certain internal milestones. He did not elaborate.
Meantime, the firm will be looking to expand Qlucore Insights, which has been designed to support additional disease models.
Qlucore Diagnostics combines machine learning-based subtyping using gene expression and gene fusion analysis and detection. "You really get the most you can get out of transcriptomics," Ivarsson said, which he noted is becoming more important with each revision of World Health Organization and European Society for Medical Oncology cancer guidelines.
Ivarsson said that the same models might work in other disease areas besides cancer. Indeed, Qlucore received a €436,000 ($468,000) grant late last year to support a five-year EU project for cardiovascular disease prevention. In terms of regulation, prevention is different from diagnosis, but Ivarsson said that the problems "can be similar" from a software perspective.
Eventually, the company may look to translate more Qlucore Insights models to the Qlucore Diagnostics IVD side, though Ivarsson was not ready to offer any details at this time.