Study Published in British Journal of Cancer Shows High Sensitivity and Specificity of Tethis' Liquid Biopsy Platform in Early Stage Breast Cancer and The Identification of Circulating Tumor Cells Clusters for the First Time in Non-Metastatic Patients

MILAN, March 25, 2021 /PRNewswire/ -- Tethis S.p.A announced the publication of a pilot study in early breast cancer showing the analytical performance of the novel SBS^® liquid biopsy platform for the accurate identification of localized breast cancer patients and, for the first time, the identification and characterization of CTC clusters in non-metastatic patients. The study, conducted in collaboration with the University Hospital Basel and led by Prof. Nicola Aceto, was performed using Tethis' automated instrument for sample preparation in conjunction with Tethis' proprietary SBS^® slides and has been published in the peer-reviewed journal British Journal of Cancer, part of the Nature Portfolio journals. The full paper can be accessed at https://www.nature.com/articles/s41416-021-01327-8.

SBS^®  liquid biopsy is a novel method that, thanks to the immediate and automated sample preparation, provides a specimen with an intact repertoire of clinically informative cells from fresh blood, allowing to achieve the highest sensitivity even in early cancer settings; this study has been conducted in blind analyzing 58 cases (30 healthy donors and 28 patients with localized breast cancer) and showed an overall sensitivity of 75%, with a 97% specificity in discriminating breast cancer patients from healthy individuals; the sensitivity was 81% on the 21 luminal-like patients, a relevant subgroup given that only ER and Her2 markers were used as a criteria for positivity. Moreover, for the first time, it was possible to identify CTC clusters in 5 out of 28 patients with early breast cancer, so far only described in metastatic settings.

"My team and I have been working on CTC clusters and their role in the metastatic process for years," said Prof. Nicola Aceto, Ph.D., Professor of Molecular Oncology and Group Leader at the Swiss Federal Institute of Technology (ETH) Zurich. "To find them in a significant proportion of patients with localized cancer is groundbreaking, and although the study is small, it paves the way for larger trials to assess their clinical significance and evaluate the efficacy of anti CTC-clusters therapeutics currently in development."

"We are thrilled about the results of this study," said Roberta Carbone, Ph.D., Chief Scientific Officer at Tethis "which strongly suggests the feasibility of a non-invasive test for early breast cancer detection based on our proprietary liquid biopsy platform. We strongly believe that immediate, standardized and gentle blood sample preparation are the key drivers for success in a difficult setting such as early cancer detection, and that our platform properly addresses these needs."

ABOUT TETHIS

Tethis S.p.A is based in Milan, Italy, and is developing a novel workflow to bring liquid biopsy in the clinical practice for the precise management of cancer. Tethis' technology points to standardization of the blood sample preparation to provide the highest quality and integrity of liquid biopsy specimens for the comprehensive analysis of clinically informative biomarkers. The company's proprietary nanocoated slides combined with the automated pre-analytical instrument allow to identify and characterize rare cells in blood, like circulating tumor cells, with unprecedented sensitivity, also in early stage settings.

Further information is available on the company's website, www.tethis-lab.com.

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