In-vitro method for diagnosing or assessing progression or response to treatment of a disorder by a circulating disease load parameter

By combining CTC and tdEV counts into a CDL parameter, the method addresses the limitations of current diagnostic and treatment assessment methods, enhancing the reliability and accuracy of cancer diagnosis and treatment evaluation.

WO2025062327A1 Publication Date: 2025-03-27MENARINI SILICON BIOSYSTEMS SPA
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Patent Information

Application Number
PCT/IB2024/059092
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2023-09-19
Filing Date
2024-09-19
Publication Date
2025-03-27

AI Technical Summary

Technical Problem

Current methods for diagnosing and assessing the progression of disorders, particularly cancer, face challenges in accurately evaluating the response to treatment due to the low frequency of circulating tumor cells (CTCs) and the limited reliability of tumor-derived extracellular vesicles (tdEV) when used separately.

Method used

The development of a method that combines the counts of CTCs and tdEVs into a single circulating disease load (CDL) parameter, which is used to assess the presence, progression, and response to treatment of disorders, particularly cancer, by integrating these indicators into a unified measure above background levels for a larger proportion of patients.

Benefits of technology

This combined approach enhances the reliability of diagnosing and assessing treatment responses by expanding the number of patients for whom a diagnosis is possible, improving the accuracy of evaluating disease progression and treatment effectiveness, and providing a more comprehensive understanding of metastatic activity.

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Abstract

The present invention relates to an in-vitro method for diagnosing or assessing the progression of a disorder in an individual or assessing the responsiveness / response to treatment in an individual, comprising : - counting a number of cells of interest and a number of cellular fragments of interest; - determining a circulating disease load ( CDL ) parameter that is a function of the number of cells of interest and the number of cellular fragments of interest,; and - correlating the circulating disease load ( CDL ) parameter with the presence or progression of the disorder or responsiveness / response to the treatment in the individual.
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