HIGHLY SENSITIVE SYSTEM AND METHODS FOR ANALYSIS OF PROSTATE SPECIFIC ANTIGEN (PSA)
First Claim
Patent Images
1. A method for detecting a single prostate specific antigen (PSA) molecule, fragment, or complex in a sample at a level less that 100 pg/ml comprising:
- a. labeling said PSA molecule, fragment, or complex, if present, with a label; and
b. detecting the presence or absence of said label, wherein detection of the presence of said label indicates the presence of said single PSA molecule, fragment, or complex of PSA in said sample.
1 Assignment
0 Petitions
Accused Products
Abstract
The invention described herein provides methods, compositions, kits, and systems for the sensitive detection of prostate specific antigen. Such methods, compositions, kits, and systems are useful in diagnosis, prognosis, and determination of methods of treatment in conditions that involve release of prostate specific antigen.
-
Citations
54 Claims
-
1. A method for detecting a single prostate specific antigen (PSA) molecule, fragment, or complex in a sample at a level less that 100 pg/ml comprising:
-
a. labeling said PSA molecule, fragment, or complex, if present, with a label; and b. detecting the presence or absence of said label, wherein detection of the presence of said label indicates the presence of said single PSA molecule, fragment, or complex of PSA in said sample. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16)
-
- 17. A method of diagnosing prostate cancer based on levels of PSA wherein the level of PSA in a sample is detected at a level of sensitivity of less than 100 pg/ml.
-
21. A method for detecting a single prostate specific antigen (PSA) molecule, fragment, or complex in a sample at a level less that 5 pg/ml comprising:
-
a. labeling said PSA molecule, fragment, or complex, if present, with a label; and b. detecting the presence or absence of said label, wherein detection of the presence of said label indicates the presence of said single PSA molecule, fragment, or complex of PSA in said sample. - View Dependent Claims (22)
-
-
23. A method for assessing the likelihood of recurrence of cancer in an individual comprising:
-
a. determining a concentration of prostate specific antigen in a sample or determining the concentrations of prostate specific antigen in a series of samples from said individual, wherein the concentration is determined by a prostate specific antigen assay with a limit of detection of said prostate specific antigen in a sample less than about 5 pg/ml; and b. determining the likelihood of recurrence of cancer for said individual, based on the concentration of prostate specific antigen in said sample, or in said concentrations of prostate specific antigen in said series of samples. - View Dependent Claims (24)
-
- 25. A method of monitoring decreases in a level of PSA after surgical resection comprising measuring the level of PSA in a first sample from an individual wherein said first sample is taken from said individual prior to surgical resection and further measuring the level of PSA in a second sample, said second sample taken from said individual after surgical resection is complete, and further comparing the levels of PSA in said first and second samples.
- 27. A method of monitoring the effectiveness of a therapeutic treatment in an individual comprising measuring the level of PSA in a first sample from said individual wherein said first sample is taken prior to administration of said therapeutic treatment and further comprising measuring the level of PSA in a series of samples taken from said individual at different time points subsequent to beginning said therapeutic treatment and further comparing the level of PSA prior to said therapeutic treatment to the level of PSA subsequent to said therapeutic treatment to determine the effectiveness of said therapeutic treatment.
- 29. A method for diagnosing breast cancer in an individual comprising comparing a level of PSA in a sample obtained from said individual to a normal range of PSA levels wherein the normal range is determined from a distribution of PSA levels in a reference population consisting of normal individuals.
- 31. A method for screening an individual for the presence of breast cancer comprising detecting a level of PSA in a series of samples taken from said individual and further detecting increases or decreases in PSA levels of said individual compared to a predetermined threshold level of PSA.
- 33. A method of diagnosing a condition indicated by increased levels of kallikreins wherein the level of kallikreins in a sample is detected at a level of sensitivity of less than 100 pg/ml.
-
35. A method for determining a diagnosis, prognosis, or method of treatment in an individual comprising:
-
a. determining a concentration of prostate specific antigen in a sample or determining the concentrations of prostate specific antigen in a series of samples from said individual, wherein said concentration is determined by a prostate specific antigen assay with a limit of detection for said prostate specific antigen in a sample less than about 100 pg/ml; and b. determining a diagnosis, prognosis, or method of treatment for said individual, based on said concentration of PSA in said sample, or on said concentrations of PSA in said series of samples. - View Dependent Claims (36, 37, 38, 39)
-
- 40. A composition for the detection of a prostate specific antigen (PSA) molecule, fragment, or complex comprising a binding partner to the prostate specific antigen molecule, fragment, or complex attached to a fluorescent moiety, wherein said fluorescent moiety is capable of emitting at least about 200 photons when stimulated by a laser emitting light at the excitation wavelength of the moiety, wherein the laser is focused on a spot not less than about 5 microns in diameter that contains the moiety, and wherein the total energy directed at the spot by the laser is no more than about 3 microJoules.
-
46. A composition comprising a set of standards for the determination of a concentration of a PSA wherein at least one of the standards is at a concentration of PSA less than about 100 pg/ml.
- 47. A kit comprising a composition comprising an antibody to prostate specific antigen attached to a fluorescent dye moiety, wherein said moiety is capable of emitting at least about 200 photons when stimulated by a laser emitting light at the excitation wavelength of the moiety, wherein the laser is focused on a spot not less than about 5 microns in diameter that contains the moiety, and wherein the total energy directed at the spot by the laser is no more than about 3 microJoules, wherein said composition is packaged in suitable packaging.
Specification