Mcm5 elisa for the detection of recurrent bladder cancer
AssigneeArquer Diagnostics Limited
InventorsJacqueline STOCKLEY, Cheryl NYBERG, Ashleigh KENNEDY
Life of this patent
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Abstract
The present invention relates to methods, uses, a first MCM5 binding agent and/or a second MCM5 binding agents and kits for detecting the presence or absence of a cancer in a subject and/or diagnosing a subject with a cancer and/or monitoring a subject for recurrence of a cancer.
Claims23
A method for detecting the presence or absence of a recurrent bladder cancer in a subject, the method comprising:
- providing a urine sample previously isolated from the subject;
- performing an assay to assess the amount of MCM5 in the sample;
- comparing the amount of MCM5 in the sample to a reference;
- determining the presence or absence of the recurrent bladder cancer in the subject based on the amount of MCM5 in the sample;
- wherein the method does not comprise cytological analysis of the subject or a sample obtained from the subject.
A method for diagnosing a subject with a recurrent bladder cancer, the method comprising:
- providing a urine sample previously isolated from the subject;
- performing an assay to assess the amount of MCM5 in the sample;
- comparing the amount of MCM5 in the sample to a reference;
- diagnosing the subject with a recurrent bladder cancer if the amount of MCM5 measured in the sample is higher than the reference or diagnosing the subject as not having a recurrent bladder cancer if the amount of MCM5 measured in the sample is lower than the reference;
- wherein the method does not comprise cytological analysis of the subject or a sample obtained from the subject.
A method for monitoring a subject for recurrence of a bladder cancer, the method comprising:
- (a) providing a urine sample previously isolated from the subject;
- (b) performing an assay to assess the amount of MCM5 in the sample;
- (c) comparing the amount of MCM5 in the sample to a reference;
- (d) determining whether the subject does or does not have a recurrent bladder cancer based on the amount of MCM5 in the sample;
- (e) repeating steps (a)-(d), optionally wherein steps (a)-(d) are repeated every month or are repeated once every 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 18, 24, or 36 months;
- wherein the method does not comprise cytological analysis of the subject or a sample obtained from the subject.
The method of any one of the preceding claims, wherein the step of performing an assay to assess the amount of MCM5 in the sample comprises:
- exposing the sample to a lysis buffer capable of releasing MCM5 from cells in the sample in order to release MCM5 from cells in the sample, optionally wherein exposing the sample to the lysis buffer comprises:
- passing the sample through a filter for capturing cells, such that cells are captured in the filter;
- and
- (i) passing the lysis buffer through the filter, such that the captured cells are exposed to the lysis buffer;
- and/or
- (ii) incubating the filter in contact with the lysis buffer for a period of time, such that the lysis buffer causes the captured cells to release the MCM5.
Use of a first MCM5 binding agent and/or a second MCM5 binding agent for detecting the presence or absence of a recurrent bladder cancer in a subject.
Use of a first MCM5 binding agent and/or a second MCM5 binding agent for monitoring a subject for recurrence of a bladder cancer.
A kit comprising:
- (i) a first MCM5 binding agent;
- (ii) a second MCM5 binding agent;
- and/or
- (iii) a lysis buffer capable of releasing MCM5 from cells in a urine sample;
- and
- (iv) instructions for use of the first MCM5 binding agent, the second MCM5 binding agent, and/or the lysis buffer in:
- a method of detecting the presence or absence of a recurrent bladder cancer in a subject, a method for diagnosing a subject with a recurrent bladder cancer, and/or a method of monitoring a subject for recurrence of a bladder cancer.
Dependencies are inferred from the claim text.