Tethis has announced the enrolment of the first two patients in the TET-22-001 clinical study of its See.d platform.
Being conducted at the European Institute of Oncology in Milan, Italy, the study is designed to assess the performance of the Tethis See.d instrument and nanocoated SmartBioSurface (SBS) slides for preparing cytological samples and plasma from whole blood for liquid biopsy applications.
Titled ‘Feasibility evaluation of See.d pre-analytical platform performance: from whole blood to plasma and SmartBioSurface slides for liquid biopsy applications,’ the study aims to validate the use of the See.d instrument in a clinical setting.
Blood samples from 20 healthy volunteers, enhanced with reference DNA and tumour model cells, have already been processed, demonstrating the system’s capability to standardise and produce high-quality cytology slides and plasma samples.
The enrolment of the first two metastatic breast cancer patients marks a significant milestone in the study, which plans to include a total of 25 participants.
The samples from these patients were processed using the See.d instrument, yielding plasma and cytology slides for further analysis of cell-free DNA and circulating tumour cells.
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This study will provide the first ‘real world’ data on the See.d instrument’s performance and ease of use in a hospital laboratory environment.
Subsequently, a performance study will be conducted to obtain CE-IVD marking for the See.d and SBS slides.
Tethis is also set to gain valuable insights from the initial analytical characterisation of liquid biopsy samples from the MBC patients.
The liquid biopsy results will be compared with concurrent tissue biopsies to support the development of a non-invasive liquid biopsy test.
Tethis CEO Dr Holger Neecke said: “The importance of standardising 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 tumour cells, along with cell-free biomarkers, all from a single blood draw.
“This holistic view of the tumour status not only empowers clinicians to guide patients towards the most suitable therapeutic options but also provides translational researchers with a deeper understanding of tumour development, paving the way for the discovery of novel targeted therapies and biomarkers.”
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- Source: https://www.medicaldevice-network.com/news/tethis-enrols-first-subjects-trial-see-d/
