Monday March 22nd 2021



Biocartis Group NV (the ‘Company’ or ‘Biocartis’), an innovative molecular diagnostics company, announces the launch of the highly innovative Idylla™ GeneFusion Assay (RUO1). The Assay detects, in one single cartridge, a wide range of biomarkers covering all gene fusions considered to be relevant in cancer research. The Idylla™ GeneFusion Assay (RUO) is therefore expected to provide a much faster testing solution for laboratories, compared to other testing methods including Next-generation Sequencing (NGS) testing which often takes days or even weeks before results are available.

Gene fusions represent an important class of somatic alterations in cancer and have become important biomarkers for cancer diagnosis, prognosis and the selection of targeted therapies2. The discovery and research for further understanding of fusion genes across multiple cancer types may provide more effective therapies in the future. Over the last 20 years, many gene fusions have been discovered in hematological cancers, solid tumors and sarcomas. Current gene fusion testing techniques are complex since these require a combination of different technologies3, often only available in different laboratories, to test all needed biomarkers. This also implies the need for sufficient sample quality and quantity which is difficult to obtain, especially for certain cancers such as lung cancer.

The Idylla™ GeneFusion Assay (RUO) includes a highly multiplexed panel of biomarkers and is the first FFPE4 RNA5-based assay on the Idylla™ platform. The Assay consolidates traditional testing workflows into one fully automated process providing objective information on ALK, ROS1, RET, NTRK1/2/3 fusions and MET exon 14 skipping, all in one cartridge, directly from 1-3 slices of FFPE tissue. Results are available within approx. 3 hours, with less than 2 minutes hands-on time. Preliminary data6 comparing the Idylla™ GeneFusion Assay (RUO) with today’s frequently used technologies such as Immunohistochemistry, FISH or NGS, show excellent results of the Assay, with concordance up to 100%.

Commenting on the launch of the Idylla™ GeneFusion Assay, Herman Verrelst, Chief Executive Officer of Biocartis, said: “This Assay is long-awaited by many of our lab-customers who, from now on, will be able to test gene fusions in a very fast and simple manner. Thanks to a unique combination of two detection technologies, the Idylla™ GeneFusion Assay (RUO) contains all relevant gene fusion biomarkers in one single cartridge, allowing labs to rapidly integrate gene fusion testing in their workflows. The benefits of this Assay not only include its speed and simplicity, but it also requires limited sample input thereby saving valuable tissue specimens. This is often an issue in areas such as biomarker testing performed on lung tissue. With the addition of the Idylla™ GeneFusion Assay (RUO) to our test menu, we can from now on offer our lab-customers a comprehensive testing solution for molecular biomarkers in this area, without the need for different instruments, and covering the majority of recognized gene fusion biomarkers.”