Tuesday May 11th 2021

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Biocartis Group NV (the ‘Company’ or ‘Biocartis’), an innovative molecular diagnostics company, announces that it has received a EUR 1.4 million grant from VLAIO, the Flanders organization for Innovation & Entrepreneurship, for the ongoing development of a new generation technology that will be deployed on the easy-to-use and fully automated molecular diagnostics platform Idylla™.

The VLAIO grant is intended to support the ongoing development of a new Idylla™ technology, which will enable the off-line customization of the Idylla™ cartridge(1). The first generation Idylla™ cartridges contain not only the generic components for sample preparation and biomarker detection, but also the biomarker-specific reagents. The next generation Idylla™ cartridges on the other hand would only contain the generic components for sample preparation and biomarker detection, and would be made biomarker-specific through the addition by the user of a ready-to-use mixture containing biomarker-specific reagents. This new Idylla™ technology would be fully compatible with the current Idylla™ cartridge manufacturing lines and installed base, and is expected to further reduce the Idylla™ assay development time and cost.

Molecular surveillance, where every patient is monitored repeatedly using a molecular test, is a rapidly growing field and represents a significant market opportunity in oncology. The development of an easy-to-use testing solution that can detect patient-specific biomarkers by using this new generation Idylla™ technology aims at decentralizing customized testing and personalized monitoring.

Benoit Devogelaere, Chief Technology Officer of Biocartis, commented: “The products that will be based on this new Idylla™ technology could potentially be used across the entire spectrum of molecular surveillance, including treatment response monitoring, Molecular Residual Disease(2) (MRD) and recurrence monitoring. The new technology could be used in the context of approved targeted therapies and immunotherapies, as well as for novel cell therapies, personalized cancer vaccines and neoantigen-targeted immunotherapies(3). We also see applications in the area of infectious diseases, where it could allow to rapidly customize Idylla™ assays for the detection and discrimination of different viruses and viral strains, which may be important in the fight against pandemic threats.”

Herman Verrelst, Chief Executive Officer of Biocartis, reacted: “We are very grateful for VLAIO’s support in bringing this new generation Idylla™ technology to market. The first generation Idylla™ technology today already disrupts the molecular diagnostics landscape thanks to its rapid, easy-to-use and fully automated nature, which enables labs to perform high-quality molecular diagnostic testing. As cancer treatment becomes increasingly personalized, we now want to enable customization and even personalization of the Idylla™ platform. This could give us an avenue into the vast market of molecular surveillance applications, where every patient is monitored repeatedly using a molecular test.”

Biocartis expects to launch the first Idylla™ products that make use of this new Idylla™ technology in the course of 2022.

(1) Previously referred to as the Idylla™ ‘FLEX’ technology
(2) Molecular Residual Disease is a small number of cancer cells left in the body after treatment. These cells have the potential to come back and cause relapse in patients. Source: MD Anderson Cancer Center, US; Last consulted here on 7 May 2021; Chin RI, Chen K, Usmani A, Chua C, Harris PK, Binkley MS, Azad TD, Dudley JC, Chaudhuri AA. Detection of Solid Tumor Molecular Residual Disease (MRD) Using Circulating Tumor DNA (ctDNA). Mol Diagn Ther. 2019 Jun;23(3):311-331. doi: 10.1007/s40291-019-00390-5. PMID: 30941670; PMCID: PMC6561896
(3) Immunotherapies that target neoantigens, which are the somatic mutations expressed only by tumor cells. This might enable tumor destruction without causing undue damage to vital healthy tissues. Source: Yamamoto, T.N., Kishton, R.J. & Restifo, N.P. Developing neoantigen-targeted T cell–based treatments for solid tumors. Nat Med 25, 1488–1499 (2019). https://doi.org/10.1038/s41591-019-0596-y, last consulted on 7 May 2021