S100A6 as blood biomarker for non-invasive diagnosis of endometriosis

An endometriosis, S100A6 technology, applied in disease diagnosis, biological testing, biological material analysis, etc., can solve problems such as 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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  • S100A6 as blood biomarker for non-invasive diagnosis of endometriosis
  • S100A6 as blood biomarker for non-invasive diagnosis of endometriosis
  • S100A6 as blood biomarker for non-invasive diagnosis of endometriosis

Examples

Experimental program
Comparison scheme
Effect test

Embodiment

[0078] In a first aspect, the present invention relates to a method of assessing whether a patient has endometriosis or is at risk of developing endometriosis comprising

[0079] a) determining the amount of S100A6 in a sample from said patient, and

[0080] b) Comparing the determined quantity with a reference.

[0081] In embodiments, an elevated amount of S100A6 in a sample from a patient is indicative of the presence or risk of developing endometriosis in the patient. In particular, if the amount of S100A6 in the patient's sample is higher than the reference or the amount of S100A6 in the reference sample, the amount of S100A6 in the patient's sample is indicative of the presence or risk of developing endometriosis in the patient. risk. In particular, in assessing the presence of endometriosis or at risk of developing endometriosis compared to the same fluid sample from individuals not suffering from endometriosis or at risk of developing endometriosis Higher amounts of...

example 1

[0176] Example 1: Diagnostic performance of biomarker S100A6 and biomarker combinations in endometriosis and control women

[0177] 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 consisted of patients with laparoscopy-diagnosed pelvic endometriosis (rASRM stages I-IV), and the control group consisted of healthy women without endometriosis.

[0178] The concentration of S100A6 in human serum was determined using the human S100A6 ELISA kit from CircuLex / MBL (distributed by Biozol Eching, Germany; catalog number: CY-8097). The kit utilizes quantitative sandwich ELISA technology. The measuring range of this assay is 37.5 pg / mL-2.4 ng / mL. Microtiter plates were pre-coated with a monoclonal antibody specific for human S100A6. Samples were measured at 200-fold dilutions. After bringing all reagents to room temperature, add 100 µL ...

example 2

[0194] Example 2 Diagnostic performance of biomarker S100A6 and biomarker combinations in adenomyosis and control women.

[0195] The case group consisted of patients diagnosed with adenomyosis by laparoscopy with subsequent histological confirmation, and the control group consisted of healthy women without adenomyosis. 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, recurrence of adenomyosis, and laparoscopy / laparotomy ≤6 months.

[0196] Concentrations of S100A6 in human serum were determined using the human S100A6 / MR8 ELISA kit from CircuLex / MBL (see Example 1 above for details).

[0197] Concentration of CA-125 was used by cobas e 601 analyzer CA 125II was determined as previously described in Example 1.

[0198] Receiver operating characteristic (ROC) curves were generated from univariate models of single biomarkers. Model perfor...

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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 S100A6 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 suffering from endometriosis or being treated with endometriosis.

Description

technical field [0001] The present invention relates to assessing whether a patient has or is at risk of developing endometriosis by determining the amount or concentration of S100A6 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 implants or cysts on the ovary, 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 lif...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/68
CPCG01N33/6893G01N2800/364G01N2470/06G01N33/689G01N2800/52
Inventor A·乔治普卢M·宏德
Owner F HOFFMANN LA ROCHE & CO AG
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