Adrenomedullin assays and methods for determining mature adrenomedullin
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Publication Number
US-11067586-B2
Publication Date
2021-07-20
Expiration Date
Abstract
Subject of the present invention is an in vitro method for therapy follow-up in septic patients wherein the concentration of mature ADM 1-52 and/or mature ADM 1-52-Gly in a sample of bodily fluid of said septic patient is determined using an assay comprising two binders that bind to two different regions within the region of mature adrenomedullin and/or adrenomedullin-Gly that is aminoacid 21-52-amid SEQ ID No. 1 or aminoacid 21-52-Gly SEQ ID No. 2 wherein each of said regions comprises at least 4 or 5 amino acids. The invention further relates to assays and calibration methods.
Core Innovation
The disclosure relates to an in vitro method for therapy follow-up for a human patient suspected of having sepsis, comprising providing a plasma or whole blood sample and detecting the concentration of mature adrenomedullin (ADM) 1-52 and/or mature ADM 1-52-Gly in the sample. The detection is performed using an assay that comprises two antibodies binding to two different regions within the region of mature adrenomedullin and/or adrenomedullin-Gly that is SEQ ID No. 1 or SEQ ID No. 2, where each of the regions comprises at least 4 or 5 amino acids.
The method applies a threshold value for the concentration of mature adrenomedullin (ADM) 1-52 and/or mature ADM 1-52-Gly from 60 to 80 pg/ml. A value below the threshold is indicative of a human patient responding to therapy, while a value above the threshold is indicative of a human patient that is not responding to therapy.
The disclosure further includes an approach where antibodies are obtained by immunizing with an antigen containing SEQ ID No. 1 or SEQ ID No. 2 and selecting an antibody that binds to at least 4 or 5 amino acids of SEQ ID No. 1 or SEQ ID No. 2.
Claims Coverage
Two independent claims are provided, each covering an in vitro therapy follow-up method for sepsis patients based on detecting mature ADM (ADM 1-52 and/or ADM 1-52-Gly) using a two-antibody assay targeting distinct sequence regions, together with threshold-based interpretation for therapy response.
Two-antibody detection of mature ADM regions with threshold-based therapy follow-up
An in vitro method for therapy follow-up providing a plasma or whole blood sample from a human patient suspected of having sepsis, detecting the concentration of mature adrenomedullin (ADM) 1-52 and/or mature ADM 1-52-Gly using an assay comprising two antibodies that bind to two different regions within the region of mature adrenomedullin and/or adrenomedullin-Gly that is SEQ ID No. 1 or SEQ ID No. 2, wherein each of said regions comprises at least 4 or 5 amino acids, applying a threshold value for the concentration of mature adrenomedullin (ADM) 1-52 and/or mature ADM 1-52-Gly from 60 to 80 pg/ml to indicate therapy response, wherein a value below said threshold is indicative of responding to therapy and a value above said threshold is indicative of not responding to therapy.
Immunization-based antibody generation for two distinct mature ADM regions with threshold-based therapy response
An in vitro method comprising providing a plasma or whole blood sample from a human patient suspected of having sepsis, detecting the concentration of mature adrenomedullin (ADM) 1-52 and/or mature ADM 1-52-Gly using an assay comprising two antibodies obtained by immunizing with an antigen containing SEQ ID No. 1 or SEQ ID No. 2 and selecting an antibody which binds to at least 4 or 5 amino acids of SEQ ID No. 1 or SEQ ID No. 2, wherein said antibodies bind to two different regions within the region of mature adrenomedullin and/or adrenomedullin-Gly that is SEQ ID No. 1 or SEQ ID No. 2, each region comprising at least 4 or 5 amino acids, wherein a threshold value below from 60 to 80 pg/ml is indicative of responding to therapy.
Across the independent claims, the coverage is directed to measuring mature adrenomedullin (ADM 1-52 and/or ADM 1-52-Gly) in plasma or whole blood from septic human patients with a two-antibody assay recognizing distinct sequence regions (each region comprising at least 4 or 5 amino acids), and interpreting therapy response using a 60–80 pg/ml threshold.
Stated Advantages
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