First Fully Automated, Standardized Pre-Analytical Platform for Comprehensive Liquid Biopsy Testing

The first ever universal blood sample preparator for liquid biopsy analysis performs a completely automated and standardized preparation of a blood sample at the point of blood collection. Cellular fraction is gently stabilized on proprietary, nanocoated SBS slides for rare cell detection, including CTCs, while plasma is made available for the analysis of cell-free content.

Tethis S.p.A (Milan, Italy) has launched the See.d universal blood sample preparator for liquid biopsy analysis that does not require specialized lab technicians and most importantly there is no need of whole blood shipment and preservation, one of the most critical points of liquid biopsy pre-analytical workflows. See.d processes fresh blood collected in EDTA tubes shortly after collection (within 4 to 6 hours) favoring maximum sample integrity. All sample preparation steps are automated: separation of plasma from the cellular fraction, red blood cells lysis and removal, white blood cells dispensation and fixation on SBS slides and plasma recovery in tubes. At the end of the process, SBS slides with a fixed monolayer of all white blood cells are made available, and the relative plasma aliquot is provided in a separate tube. Both specimens are perfectly stable for several days, having received minimum manipulation, contamination or shear stress before stabilization.

SBS slides are compatible with all analytical pathology techniques, including cytology, immunocytochemistry (ICC), Immunofluorescence (IF), Fluorescence in Situ Hybridization (FISH), for morphological and biomarker-based analysis through brightfield or fluorescence image acquisition. The extremely efficient cell adhesion and the preserved morphology, together with the optimal distribution of the cells on the slides as a monolayer, allows the implementation of AI supported digital imaging for automated and efficient detection, classification and profiling of rare circulating tumor cells as well as of the immune cell compartment. Furthermore, identified cells can be recovered through microdissection for downstream molecular analysis at single cell level. Plasma - on the other hand - is stable for several days with no need for freezing and ready for cfNA extraction without any further centrifugation step. The lean and automated processing provides uncontaminated, standardized plasma for high quality, reproducible downstream analysis of cell-free content.

"This is a key development milestone not just for Tethis but hopefully for liquid biopsy adoption," said Mr. Gian Martino Franchi, Chief Technology Officer of the company. "We have leveraged on our proprietary nanocoated slides that allow immediate, spontaneous and gentle adhesion of normally non adherent cells, to develop a fully automated platform that not only fixes all white blood cells for enrichment-free rare cell detection, but also provides a perfectly stable plasma fraction for cell-free content analysis, allowing to have an optimal preparation of all relevant content for liquid biopsy testing. This is a first of its kind, and we trust that it can contribute to the long-awaited standardization of blood processing for liquid biopsies. We've been closely working with our partner MACS srl for the development of this first release, and we have already started planning the next generation platform that will further enhance easiness of use, efficiency and throughput."

"We are thrilled to introduce this novel solution to the market," said Ms. Roberta Carbone, Ph.D, Tethis' Chief Scientific Officer. "It's a first step towards true multi-analytical, standardized liquid biopsy tests involving all possible tumor content released in the bloodstream. We are now working on the validation for CE-IVD marking of the platform and on the development of novel liquid biopsy tests to bring to patients and at-risk individuals, but we also welcome diagnostics industry players and drug developers who want to exploit the optimal and comprehensive preparation guaranteed by See.d for the development of new tests and companion diagnostics or for patients' stratification in clinical trials."

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Tethis S.p.A