JP-2022513525-A5 -

Dates

Publication Date

20221227

Application Date

20191219

Description

All publications referenced in the above specification are incorporated herein by reference. Various modifications and variations of the described aspects and embodiments of the present invention will be apparent to those skilled in the art without departing from the scope of the invention. Although the present invention is described in relation to certain preferred embodiments, it should be understood that the claimed invention should not be excessively limited to such specific embodiments. In fact, various modifications of the described style for carrying out the invention, which will be apparent to those skilled in the art, are intended to fall within the scope of the following claims. The following are embodiments of the present invention. [1] A method for detecting the presence or absence of gynecological cancer in a subject, The steps of obtaining a non-invasive sample isolated from the subject, and A step of detecting at least one biomarker or determining the concentration of at least one biomarker. Methods that include... [2] The method according to [1], wherein the non-invasive sample is selected from the group consisting of a urine sample, a tampon sample, and a vaginal swab sample. [3] Further comprising the step of comparing the concentration of the determined at least one biomarker with a reference, preferably the reference being the average concentration of the at least one biomarker determined for one or more samples prepared from one or more healthy individuals, if necessary, (i) If the concentration of the at least one biomarker is abnormal compared to the reference, there is a possibility of gynecological cancer being present, and/or (ii) If the concentration of at least one biomarker is higher than the reference, there is a possibility of gynecological cancer being present. The method described in [1] or [2]. [4] The step of detecting the at least one biomarker or determining the concentration of the at least one biomarker is Perform an ELISA assay to detect the at least one biomarker or to determine the concentration of the at least one biomarker. Includes, and as needed, (a) The concentration of the at least one biomarker is 5 pg/mL, 6 pg/mL, 7 pg/mL, 8 pg/mL, 9 pg/mL, 10 pg/mL, 11 pg/mL, 12 pg/mL, 13 pg/mL, 14 pg/mL, 15 pg/mL, 16 pg/mL, 17 pg/mL, 18 pg/mL, 19 pg/mL, 20 pg/mL, 21 pg/mL, 2 If the level is determined to be higher than 2 pg/mL, 23 pg/mL, 24 pg/mL, 25 pg/mL, 26 pg/mL, 27 pg/mL, 28 pg/mL, 29 pg/mL, 30 pg/mL, 35 pg/mL, 45 pg/mL, 50 pg/mL, 55 pg/mL, 60 pg/mL, 65 pg/mL, or 70 pg/mL, there is a possibility that the aforementioned gynecological cancer is present. (b) If the concentration of the at least one biomarker is determined to be higher than (i) about 12 pg/mL, (ii) about 17 pg/mL, or (iii) about 70 pg/mL, preferably about 12 pg/mL, then there is a possibility of gynecological cancer being present, and/or (c) The method according to any one of [1] to [3], wherein a cutoff of 12 pg/mL, 17 pg/mL, or 70 pg/mL, preferably about 12 pg/mL, is applied. [5] The method described above is a method for diagnosing gynecological cancer in the subject, and if necessary, the method described above may be Steps to diagnose the subject as having gynecological cancer when there is a possibility of gynecological cancer being present. The method according to any one of [1] to [4], further including the method described above. [6] A method for diagnosing a subject as having gynecological cancer or a benign gynecological condition, A step of providing a non-invasive sample previously isolated from the subject, A step of determining the concentration of at least one biomarker in the non-invasive sample, A step of comparing the concentration of the at least one biomarker in the non-invasive sample with a reference, The step of diagnosing the subject as having gynecological cancer if the concentration of the at least one biomarker in the non-invasive sample is higher than the reference, or diagnosing the subject as having a benign gynecological condition if the concentration of the at least one biomarker in the non-invasive sample is lower than the reference. Methods that include... [7] A method for distinguishing between non-invasive samples related to gynecological cancer and non-invasive samples related to benign gynecological cancer, A step of providing a non-invasive sample that has been previously isolated from the subject, A step of determining the concentration of at least one biomarker in the non-invasive sample, A step of comparing the concentration of the at least one biomarker in the non-invasive sample with a reference, The steps involve determining that the non-invasive sample is associated with gynecological cancer if the concentration of the at least one biomarker in the non-invasive sample is higher than the reference, or determining that the non-invasive sample is associated with a benign gynecological condition if the concentration of the at least one biomarker in the non-invasi