Use of mcm5 as a marker in semen for prostate cancer
AssigneeArquer Diagnostics Limited
InventorsJacqueline STOCKLEY, Cheryl NYBERG
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Abstract
The present invention relates to a method for detecting the presence or absence of a prostate cancer in a subject, the method comprising steps of: providing a semen sample obtained from the subject; and detecting at least one biomarker or determining the concentration of at least one biomarker. The present invention also relates to lysis buffers, monoclonal antibodies, and kits that can be used in such methods.
Claims21
A method for detecting the presence or absence of a prostate cancer in a subject, the method comprising steps of:
- providing a semen sample obtained from the subject;
- and
- detecting at least one biomarker or determining the concentration of at least one biomarker.
The method of any one of the preceding claims, wherein the semen sample is obtained after a period of abstinence.
The method of any one of the preceding claims, wherein:
- detecting the at least one biomarker comprises determining whether the concentration of the biomarker is higher than a pre-defined cut-off.
The method of any one of the preceding claims, wherein the concentration of the at least one biomarker is compared to a reference, and prostate cancer is likely to be present if the concentration of the at least one biomarker is abnormal compared to or higher than the reference, optionally wherein the method is a method for diagnosing prostate cancer, and the method further comprises a step of diagnosing the subject as having prostate cancer if the concentration of the at least one biomarker is higher than the reference.
The method of any one of the preceding claims, wherein:
- (a) determining the concentration of the at least one biomarker or determining whether the concentration of the at least one biomarker is higher than a pre-defined cut-off is carried out using an ELISA assay;
- (b) the method has a sensitivity of greater than 40%, greater than 50%, greater than 60%, between 40% and 100%, between 50% and 100%, between 60% and 100%, or around 61%;
- (c) the method has a sensitivity of greater than 40%, greater than 50%, greater than 60%, between 40% and 100%, between 50% and 100%, between 60% and 100%, or around 61% using a pre-defined cut-off of 65 pg/mL;
- (d) the method has a specificity of greater than 70%, greater than 75%, between 70% and 100%, between 75% and 100%, or around 79%;
- (e) the method has a specificity of greater than 70%, greater than 75%, between 70% and 100%, between 75% and 100%, or around 79% using a pre-defined cut-off of 65 pg/mL;
- (f) the method has a positive predictive value (PPV) of greater than 60%, greater than 70%, greater than 75%, between 60% and 100%, between 70% and 100%, between 75% and 100%, or around 78%;
- (g) the method has a positive predictive value (PPV) of greater than 60%, greater than 70%, greater than 75%, between 60% and 100%, between 70% and 100%, between 75% and 100%, or around 78% using a pre-defined cut-off of 65 pg/mL;
- (h) the method has a negative predictive value (NPV) of greater than 55%, greater than 60%, between 55% and 100%, between 60% and 100%, or around 63%;
- (i) the method has a negative predictive value (NPV) of greater than 55%, greater than 60%, between 55% and 100%, between 60% and 100%, or around 63% using a pre-defined cut-off of 65 pg/mL;
- and/or
- (j) the method has greater sensitivity, specificity, NPV and/or PPV than an equivalent method carried out using a urine sample, optionally wherein the equivalent method carried out using a urine sample uses a cut-off of 3 pg/mL.
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:
- exposing the semen sample to a first monoclonal antibody and/or a second monoclonal antibody;
- and
- detecting the at least one biomarker bound to the first monoclonal antibody and/or the second monoclonal antibody or determining the concentration of the at least one biomarker bound to the first monoclonal antibody and/or the second monoclonal antibody, optionally wherein the first monoclonal antibody and the second monoclonal antibody bind to MCM5.
Use of a lysis buffer as defined in any one of the preceding claims in a method of detecting the presence of absence of prostate cancer in a subject.
Use of a first monoclonal antibody as defined in any one of the preceding claims and/or a second monoclonal antibody as defined in any one of the preceding claims in a method of detecting the presence or absence of prostate cancer in a subject.
Use of a kit in a method of detecting the presence or absence of prostate 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 prostate cancer in a subject.
The method, use or kit of any one of the preceding claims, wherein the prostate cancer is grade 4/5.
Dependencies are inferred from the claim text.