Materials and methods for extracellular vesicle detection

Inventors

Daunert, Sylvia • YANG, YU-PING

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Assignees

University of Miami

The University of Miami, established in 1925 and based in Coral Gables, Florida, is a private research university recognized for its comprehensive academic offerings, robust research infrastructure, and strong interdisciplinary focus. Home to more than 19,000 students and with more than 400 acres of campuses across the Miami region, its mission encompasses education, research, innovation, and community service. The institution supports clinical, biomedical, marine, and atmospheric research initiatives, delivers diverse undergraduate and graduate programs, and maintains numerous research centers and institutes dedicated to scientific, medical, and societal advancements.

Publication Number

US-12590964-B2

Patent

Publication Date

2026-03-31

Expiration Date


Abstract

Described herein is a method for detecting the presence of circulating extracellular vesicles in a subject. The method comprises contacting a biological sample from the subject with an antibody mimetic that specifically binds to a cell surface marker on the vesicles, wherein the antibody mimetic is coupled to a detectable label; and detecting presence of extracellular vesicles in the sample by detecting the presence of the detectable label coupled to the antibody mimetic bound to the vesicles.

Core Innovation

The document describes an extracellular vesicle detection assay for detecting the presence of circulating extracellular vesicles in a subject. The assay contacts a biological sample from the subject with a fusion protein comprising the amino acid sequence set forth in SEQ ID NO: 2, where the fusion protein is coupled to a detectable label. The assay then detects the presence of extracellular vesicles in the sample by detecting the detectable label coupled to the fusion protein bound to the vesicles.

The fusion protein is described as an antibody mimetic that binds a cell surface marker, and the detectable label provides a readout of vesicle binding. The document includes tumor-derived extracellular vesicles, including exosomes and microvesicles, and includes ovarian tumor-derived extracellular vesicles as a specific vesicle population of interest. Biological samples include serum and plasma for detecting circulating vesicles.

The document further describes embodiments that include extracellular vesicle enrichment using magnetic capture. In these embodiments, phosphatidylserine (PS)-binding proteins are used to provide a magnetic capture of vesicles, and streptavidin magnetic beads and/or magnetic particles are used in connection with biotinylated conjugates. The resulting vesicle-associated detectable label is then detected.

Claims Coverage

Two independent claims are provided, both based on contacting a biological sample with a SEQ ID NO: 2 fusion protein coupled to a detectable label and then detecting the label associated with bound extracellular vesicles. The second independent claim narrows the method to circulating ovarian tumor-derived extracellular vesicles.

Detecting circulating extracellular vesicles using a SEQ ID NO: 2 fusion protein with a detectable label

A method for detecting the presence of circulating extracellular vesicles in a subject by contacting a biological sample with a fusion protein comprising the amino acid sequence set forth in SEQ ID NO: 2, coupled to a detectable label, and detecting the detectable label coupled to the fusion protein bound to the vesicles.

Detecting circulating ovarian tumor-derived extracellular vesicles using a SEQ ID NO: 2 fusion protein with a detectable label

A method of detecting the presence of circulating ovarian tumor-derived extracellular vesicles in a subject by contacting a biological sample with a fusion protein comprising the amino acid sequence set forth in SEQ ID NO: 2, coupled to a detectable label, and detecting the detectable label coupled to the fusion protein bound to the ovarian tumor extracellular vesicles.

Across the independent claims, the core inventive concept is detecting circulating extracellular vesicles by binding vesicles with a SEQ ID NO: 2 fusion protein coupled to a detectable label, followed by detecting the label associated with the vesicles. The ovarian-tumor specificity is provided by the claim limitation to circulating ovarian tumor-derived extracellular vesicles.

Stated Advantages

Not explicitly described in patent.

Documented Applications

Diagnostic use for ovarian cancer is described in the document.

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