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Publication Number
US-12234500-B2
Publication Date
2025-02-25
Expiration Date
2038-12-27
Abstract
The present invention relates to compositions and methods for binding and detecting or measuring renalase. In one embodiment, the renalase binding molecule measures renalase amount or activity. Thus, in diseases and conditions where a measurement of renalase is beneficial, such renalase binding molecules may act as diagnostics.
Core Innovation
The invention provides compositions and methods for binding, detecting, and measuring renalase. It includes antibodies or binding portions thereof that specifically bind to renalase or its fragments. These antibodies may be monoclonal, polyclonal, single chain, immunoconjugates, humanized, chimeric, fully human, or antibody mimetics, and can comprise defined CDR sequences or variable regions.
The problem addressed is the lack of highly selective and well-characterized reagents for detecting renalase, which is necessary to validate renalase as a biomarker and to enable accurate diagnosis, prognosis, and treatment of renalase-associated diseases, such as renal, cardiovascular, and cancer conditions. The patent highlights the need for improved methods and specific reagents, like the described antibodies, to enable such measurement.
The invention establishes reference standards for renalase measurement, including acid-treated recombinant renalase, renalase fragments, and synthetically-derived peptides (RPC1, RPC2, and RPC3). These standards improve assay reproducibility and reliability, allowing measurement of both total and free renalase in various biological samples. The methods described include immunoassays such as ELISA, western blot, immunoprecipitation, and immunocytochemistry, using the invented antibodies and standards.
Claims Coverage
There is 1 independent claim in the patent, with its main inventive feature as follows.
Reference standards for renalase measurement
The invention defines a reference standard consisting of one of the peptides: RPC1 (SEQ ID NO:226), RPC2 (SEQ ID NO:227), or RPC3 (SEQ ID NO:228). These reference standards are used for measuring renalase in accordance with the methods described in the patent.
The claim coverage is focused on the synthetic peptide reference standards specifically defined as RPC1, RPC2, and RPC3 for use as renalase measurement standards.
Stated Advantages
The use of defined reference standards like RPC1, RPC2, and RPC3 enables improved reproducibility and accuracy in the quantification of renalase, overcoming issues with recombinant renalase instability.
The invention enables highly sensitive, reproducible, and user-friendly assays for detecting and quantifying renalase in complex biological samples.
Documented Applications
Measurement of renalase levels in biological samples such as blood, serum, plasma, urine, and tissue lysates for diagnosis or prognosis of renal disease, cardiovascular disease, and cancer.
Use of the assay standards and methods for monitoring the effect of treatment for diseases or disorders associated with altered renalase levels.
Use in sandwich ELISA, Western blot, immunoprecipitation, immunocytochemistry, and related immunoassays to detect renalase in clinical or research settings.
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