Tethis S.p.A. announces enrollment of the first two patients in a clinical study of its See.d platform which allows automated standardized plasma and cell sample preparation for multiomic liquid biopsy

MILAN, April 2, 2024 /PRNewswire/ -- Tethis S.p.A., a pioneer in the development of an innovative platform for liquid biopsy testing, is pleased to announce the enrollment of the first two patients in the clinical study TET-22-001. This study, titled "Feasibility evaluation of See.d pre-analytical platform performance: from whole blood to plasma and SmartBioSurface^® slides for liquid biopsy applications", is being conducted at the European Institute of Oncology in Milan, Italy.

This study aims to assess the performance of the Tethis See.d instrument in conjunction with nanocoated SmartBioSurface^® (SBS) slides for the automatic preparation of cytological samples (seeded on SBS slides) for the detection of rare tumor and immune cells, as well as plasma from fresh whole blood collected from study participants. Blood samples have already been collected from twenty healthy volunteers, spiked with reference DNA and tumor model cells to mimic patient samples. These samples have been processed at Tethis yielding outstanding results in terms of standardization and quality of the automatically produced cytology slides and plasma samples.

In the last few days, the first two Metastatic Breast Cancer (MBC) patients have been enrolled from a total cohort of twenty-five. Their blood samples were successfully processed using a See.d instrument at the European Institute of Oncology, generating plasma and cytology slides for further analytical characterization of cell-free DNA (cfDNA) and Circulating Tumor Cells (CTCs). The study will yield the first set of "real world" data on the performance and user-friendliness of Tethis' See.d instrument in a clinical hospital laboratory setting. The next step involves conducting a performance study aimed at achieving CE-IVD marking for See.d and SBS slides.

"We are excited to collaborate with the European Institute of Oncology for this study. The importance of standardizing sample preparation cannot be overstated, as it significantly enhances the precision of downstream analytical tests. See.d-processed samples facilitate multiomic liquid biopsy analysis, allowing examination of white blood cells and rare circulating tumor cells, along with cell-free biomarkers, all from a single blood draw. This holistic view of the tumor status not only empowers clinicians to guide patients towards the most suitable therapeutic options, but also provides translational researchers with a deeper understanding of tumor development, paving the way for the discovery of novel targeted therapies and biomarkers," states Dr. Holger Neecke, CEO of Tethis.

In addition to performance data of the instrument, Tethis will gather valuable insights from the initial analytical characterization of the liquid biopsy samples from MBC patients. Plasma will be analyzed for circulating tumor DNA, and the cytology slides will be examined for circulating tumor cells. The results of the liquid biopsy will be compared to tissue biopsies taken concurrently with the goal to guide the development of a non-invasive liquid biopsy test.

"The development of a non-invasive liquid biopsy test could be particularly helpful for metastatic breast cancer patients. For many of these advanced-stage patients, tissue biopsy is not a viable option, as metastases are often located in multiple difficult-to-access locations and the collection is painful and associated with risks. Furthermore, the possibility to rely on cellular and cell-free biomarkers provides better disease characterization, facilitating the selection of the best personalized treatment for the patient," says Dr. Luca Mazzarella, Principal Investigator at the European Institute of Oncology.

Additional details can be found on ClinicalTrials.gov (Evaluation of See.d as an Automated Blood Sample Preparator for Multiple Liquid Biopsy Applications, NCT06097156).

The See.d instrument and SmartBioSurface^® slides are for Research Use Only and are not intended for use in diagnostic procedures.

About See.d

See.d is the first universal blood sample preparator designed specifically for liquid biopsy analysis. This innovative instrument performs a fully automated and standardized blood sample preparation at the point of blood collection. The cellular fraction is gently stabilized on proprietary, nanocoated SBS slides for the detection of rare cells, including CTCs, while plasma is made available for the analysis of cfDNA, cfRNA/miRNA, proteins, metabolites and exosomes. Indeed, See.d processes fresh blood collected in EDTA tubes shortly after collection, favoring maximum sample integrity and clinical informativity. All sample preparation steps are automated: separation of plasma from the cellular fraction, red blood cell lysis and removal, white blood cell 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 (i.e., cytology slides), and the relative plasma aliquot is provided in a separate tube. 

About SmartBioSurface^® slides

Nanocoated SmartBioSurface^® (SBS) slides allow spontaneous adhesion of otherwise non-adhering cells and are compatible with all analytical pathology techniques, including cytology, immunocytochemistry, immunofluorescence and FISH (Fluorescence In Situ Hybridization) 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 multiplexing and 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.

About Tethis

Tethis is a diagnostic company engaged in the development of an innovative workflow to integrate liquid biopsy into clinical practice, offering precise cancer management. Tethis' technology focuses on standardizing the preparation of blood samples to ensure the highest quality and integrity of liquid biopsy specimens. This approach facilitates a comprehensive analysis of all clinically relevant biomarkers. The company's nanocoated SBS slides, in conjunction with the See.d instrument, enable the identification and characterization of rare cells in the blood, such as circulating tumor cells, with unparalleled sensitivity, even in early-stage settings. The company is headquartered in Milan, Italy. More information can be found at www.tethis-lab.com.

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