S100A12 as blood biomarker for non-invasive diagnosis of endometriosis

A technology of S100A12, endometriosis, applied in the direction of disease diagnosis, biological testing, biomaterial analysis, etc., can solve the problem of limited diagnostic utility

Pending Publication Date: 2022-03-04
F HOFFMANN LA ROCHE & CO AG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

CA-125 is one of the most commonly used blood biomarkers, however, its diagnostic utility is limited to rASRM stages III and IV of endometriosis (Nisenblat et al., Cochrane Database of Systematic Reviews. 2016;5:CD012179)

Method used

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  • S100A12 as blood biomarker for non-invasive diagnosis of endometriosis
  • S100A12 as blood biomarker for non-invasive diagnosis of endometriosis
  • S100A12 as blood biomarker for non-invasive diagnosis of endometriosis

Examples

Experimental program
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Effect test

Embodiment

[0080] In a first aspect, the present invention relates to a method of assessing whether a patient suffers from or is at risk of developing endometriosis, comprising

[0081] a) determining the amount of said S100A12 in a sample from said patient, and

[0082] b) Comparing the determined quantity with a reference.

[0083] In an embodiment, an elevated amount of S100A12 in a patient sample indicates that the patient has or is at risk of developing endometriosis. In particular, if the amount of S100A12 in the patient sample is higher than the reference or the amount of S100A12 in the reference sample, the amount of S100A12 in the patient sample indicates that the patient has endometriosis or is at risk of developing endometriosis. In particular, in patients assessed as having endometriosis or at risk of developing endometriosis compared to the same fluid sample from individuals without endometriosis or at risk of developing endometriosis Higher amounts of S100A12 were detecte...

example 1

[0175] Example 1: Diagnostic performance of biomarker S100A12 and biomarker combinations in women with endometriosis and controls

[0176] For the measurements, a total of 21 serum and 31 plasma samples from human females were analyzed. Analyte concentrations were determined by ELISA (Enzyme-Linked Immunosorbent Assay). The case group included patients with laparoscopy-diagnosed pelvic endometriosis (rASRM stages I-IV), and the control group included healthy women without endometriosis.

[0177] The concentration of S100A12 in human serum was determined using the Human S100A12 / EN-RAGE ELISA Kit Ver. 2 from CircuLex / MBL (distributed by Biozol Eching, Germany; catalog number: CY-8058V2). The kit uses quantitative sandwich ELISA technology. Microtiter plates were pre-coated with a monoclonal antibody specific for human S100A12. Samples were measured at 200-fold dilutions. After bringing all reagents to room temperature, add 100 µL of each sample and standard. Sample single m...

example 2

[0193] Example 2: Diagnostic performance of biomarker S100A12 and biomarker combinations in samples from a multicenter study in women with endometriosis and controls.

[0194] The case groups included patients diagnosed with peritoneal endometriosis, deep infiltrating endometriosis, and endometriosis. Endometriosis (rASRM stages I-IV) was diagnosed by laparoscopic visualization and subsequent histological confirmation, and controls included healthy women without endometriosis. Inclusion criteria for the case group were presence of pelvic pain / infertility and age between 18-45 years. The exclusion criteria for the case group were pregnancy / lactation, malignancy, recurrent endometriosis, and laparoscopy / laparotomy ≤6 months.

[0195] S100A12 was measured using the pre-commercial ECLIA assay for S100A12, a cobas Sandwich immunoassay developed on the ECLIA platform (ECLIA assay from Roche Diagnostics, Germany). The assay includes biotinylated and ruthenated monoclonal antibodi...

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Abstract

The present invention relates to a method of assessing whether a patient has or is at risk of developing endometriosis by determining the amount or concentration of S100A12 in a sample of the patient and comparing the determined amount or concentration to a reference, a method of selecting a patient for therapy, and methods of monitoring a patient who has endometriosis or is being treated against endometriosis.

Description

[0001] The present invention relates to assessing whether a patient suffers from or is at risk of developing endometriosis by determining the amount or concentration of S100A12 in a sample of the patient and comparing the determined amount or concentration with a reference Methods of selecting patients for therapy, and methods of monitoring patients with or being treated for endometriosis. Background technique [0002] Endometriosis is defined as the presence of endometrial glands and stroma-like lesions outside the uterus. Lesions can be peritoneal lesions, superficial ovarian implants or cysts, or deep invasive disease. Endometriosis affects 5-8% of all women of reproductive age and 70% of women with chronic pelvic pain. An estimated 176 million women worldwide suffer from endometriosis (Adamson et al. J Endometr. 2010; 2:3-6). For many of these women, the diagnosis of endometriosis is often delayed, leading to unnecessary suffering and reduced quality of life. Among pati...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/53G01N33/533
CPCG01N33/53G01N33/533G01N33/6893G01N2800/364G01N2800/52
Inventor A·乔格普卢F·格鲁内瓦尔德M·宏德M·克拉默H·韦格迈耶
Owner F HOFFMANN LA ROCHE & CO AG
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