Use of mcm5 as a marker for gynaecological cancers

The method of any one of the preceding claims, wherein the step of detecting the at least one biomarker or determining the concentration of the at least one biomarker comprises:

• performing an ELISA assay to detect the at least one biomarker or determine the concentration of the at least one biomarker, optionally wherein:
• (a) the gynaecological cancer is likely to be present if the concentration of the at least one biomarker is determined to be higher than 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, 22 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;
• (b) the gynaecological cancer is likely to be present 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 and/or
• (c) a 12 pg/mL, 17 pg/mL or 70 pg/mL, preferably about 12 pg/mL, cut-off is applied.

A method for diagnosing a subject as having a gynaecological cancer or a benign gynaecological condition, the method comprising the steps of:

• providing a non-invasive sample previously isolated from the subject;
• determining the concentration of at least one biomarker in the non-invasive sample;
• comparing the concentration of the at least one biomarker in the non-invasive sample to a reference;
• diagnosing the subject as having a gynaecological 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 gynaecological condition if the concentration of the at least one biomarker in the non-invasive sample is lower than the reference.

A method for distinguishing between a non-invasive sample associated with a gynaecological cancer and a non-invasive sample associated with a benign gynaecological cancer, the method comprising the steps of:

• providing a non-invasive sample previously isolated from a subject;
• determining the concentration of at least one biomarker in the non-invasive sample;
• comparing the concentration of the at least one biomarker in the non-invasive sample to a reference;
• determining that the non-invasive sample is associated with a gynaecological 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 gynaecological condition if the concentration of the at least one biomarker in the non-invasive sample is lower than the reference.

The method of any one of the preceding claims, wherein:

• (a) the method has a sensitivity for the gynaecological cancer of at least about 20%, 22%, 24%, 26%, 28%, 30%, 32%, 34%, 36%, 38%, 40%, 42%, 44%, 46%, 48%, or 50%;
• (b) the method has a sensitivity for the gynaecological cancer of at least about 50%, 52%, 54%, 55%, 56%, 57%, 58%, 59%, 60%, or 61%;
• (c) the method has a sensitivity for the gynaecological cancer of at least about 75%, 76%, 77%, 78%, 79%, 80%, or 81%;
• (d) the method has a sensitivity for the gynaecological cancer of at least about 90%, 92%, 93%, 94%, 95%, or 96%;
• (e) the method has a specificity for the gynaecological cancer of at least about 20%, 22%, 24%, 26%, 28%, 30%, 32%, 34%, 36%, 38%, or 40%;
• (f) the method has a specificity for the gynaecological cancer of at least about 50%, 52%, 54%, 55%, 56%, 57%, 58%, 59%, or 60%;
• (g) the method has a specificity for the gynaecological cancer of at least about 60%, 62%, 64%, 66%, 68%, 70%, 71%, 72%, 73%, 74%, or 75%;
• and/or
• (h) the method has a specificity for the gynaecological cancer of at least about 80%, 82%, 83%, 84%, 85%, or 86%.

Use of a kit in a method of detecting the presence or absence of a gynaecological cancer in a subject, wherein the kit comprises:

• (a) a lysis buffer as defined in any one of the preceding claims;
• (b) a first monoclonal antibody as defined in any one of the preceding claims;
• and/or
• (c) a second monoclonal antibody as defined in any one of the preceding claims.

A kit comprising:

• (a) a lysis buffer as defined in any one of the preceding claims;
• (b) a first monoclonal antibody as defined in any one of the preceding claims;
• and/or
• (c) a second monoclonal antibody as defined in any one of the preceding claims;
• and
• (d) instructions for use of the lysis buffer and/or the first monoclonal antibody and/or the second monoclonal antibody in a method of detecting the presence or absence of a gynaecological cancer in a subject.

The method, use or kit of any one of the preceding claims, wherein:

• (a) the gynaecological cancer is an ovarian cancer and the method has a specificity for the ovarian cancer of at least about 25%;
• (b) the gynaecological cancer is an ovarian cancer and the method has a sensitivity for the ovarian cancer of at least about 50%;
• (c) the gynaecological cancer is an ovarian cancer and the method has a specificity for the ovarian cancer of at least about 25% and a sensitivity for the ovarian cancer of at least about 50%;
• (d) the gynaecological cancer is an endometrial cancer and the method has a specificity for the endometrial cancer of at least about 40%;
• (e) the gynaecological cancer is an endometrial cancer and the method has a sensitivity for the endometrial cancer of at least about 80%;
• and/or
• (f) the gynaecological cancer is an endometrial cancer and the method has a specificity for the endometrial cancer of at least about 40% and a sensitivity for the endometrial cancer of at least about 80%.