US5800347A
Expired / Lapsed
US
⏱️ 0.0 years remaining
ROC method for early detection of disease
Assignee: Queen Mary University of London
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Filing: 1995-11-03
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Granted: 1998-09-01
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Expires: 2015-11-03
Abstract
Abstract A method of assessing risk of an individual for a disease is disclosed. A level of a marker for the disease is detected, and the risk of disease is computed from a statistical analysis of the marker level distributions for tested normal and diseased populations, using multivariate distributions. The computed risk is compared to thresholds to triage the individual into a normal, borderline, or elevated risk group, and a course of action based on the risk group is determined. Memory storing a program for execution on a data processing system, as well as a computer system comprising said memory is also disclosed, the memory comprising a receiver for signals representative of levels of a marker for the disease; a central procesing unit for computing risk of disease from one or more levels of the marker, and for comparing the computed risk to thresholds to triage the individual; and storage medium for the marker levels for subsequent computations of risk of disease.
Inventors
- 👤 Steven J. Skates
- 👤 Ian Jacobs
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-30 17:53
CPC Classifications
A; A61; A61B; A61B5/00; A61B5/72; A61B5/7271; A61B5/7275; G; G01; G01N; G01N33/00; G01N33/48; G01N33/50; G01N33/53; G01N33/575; G01N33/57545; G16; G16H; G16H50/00; G16H50/20; G16H50/30; Y; Y10; Y10S; Y10S128/00; Y10S128/92; Y10S128/923
Claims Analysis
Total Claims: 34
Claim 1
Independent Claim
97 words
A method of assessing the risk of an individual for a disease, comprising: a) testing the individual to detect a level of a marker for the disease; b) computing risk of disease from a detected level of the marker; and c) comparing the computed risk to thresholds to triage the individual into one of normal, borderline and elevated risk groups, wherein if the individual is triaged to a borderline risk group, the step of testing the individual to detect the level of the marker is repeated at a retest interval substantially less than a routine screening interval.
Claim 2
Independent Claim
97 words
A method of assessing the risk of an individual for a disease, comprising: a) testing the individual to detect a level of a marker for the disease; b) computing risk of disease from a detected level of the marker; and c) comparing the computed risk to thresholds to triage the individual into one of normal, borderline and elevated risk groups, wherein if the individual is triaged to a borderline risk group, the step of testing the individual to detect the level of the marker is repeated at a retest interval substantially less than a routine screening interval.
Claim 3
Dependent Claim
38 words
A method as claimed in claim 1, wherein if the individual is triaged to a normal risk group, the step of testing the individual to detect the level of the marker is repeated at a routine screening interval.
Claim 4
Dependent Claim
49 words
A method as claimed in claim 1, wherein if the individual is again triaged to a borderline risk group upon repeat testing, the step of testing the individual is again repeated to detect the level of the marker at a retest interval substantially less than a routine screening interval.
Claim 5
Dependent Claim
18 words
A method as claimed in claim 1 wherein the retest interval is inversely related to the computed risk.
Claim 6
Dependent Claim
33 words
A method as claimed in claim 1 wherein, if the individual is triaged into an elevated risk group, the individual is subjected to a secondary test to determine likelihood of presence of disease.
Claim 7
Dependent Claim
31 words
A method as claimed in claim 5 wherein the individual is a postmenopausal woman, the disease is ovarian cancer, the marker is CA125 and the secondary test is an ultrasonographic test.
Claim 8
Dependent Claim
32 words
A method as claimed in claim 5 wherein, if the individual is triaged into the elevated risk group, the level of the marker is again detected and the risk is again computed.
Claim 9
Dependent Claim
38 words
A method as claimed in claim 7 wherein, if results of the secondary test are equivocal, the secondary test is repeated and a course of action is determined based on results of the repeated test or recomputed risk.
Claim 10
Dependent Claim
28 words
A method as claimed in claim 7 wherein, if the results of the secondary test are normal, a course of action is determined based on a recomputed risk.
Claim 11
Dependent Claim
24 words
A method as claimed in claim 1 wherein the individual is a postmenopausal woman, the disease is ovarian cancer and the marker is CA125.
Claim 12
Dependent Claim
35 words
A method as claimed in claim 10 wherein, if the individual is triaged into an elevated risk group, the individual is subjected to a secondary test of ultrasound examination to determine a course of action.
Claim 13
Dependent Claim
33 words
A method as claimed in claim 10 wherein the individual is triaged to the borderline risk group if the risk of disease is computed to be in a range of 0.05 to 4%.
Claim 14
Dependent Claim
28 words
The method of claim 1 wherein the risk of the disease is computed from a statistical analysis of the marker level distributions for tested normal and diseased populations.
Claim 15
Dependent Claim
15 words
A method as claimed in claim 13 wherein the risk is determined from multivariate distributions.
Claim 16
Dependent Claim
46 words
A method as claimed in claim 14 wherein the marker level changes exponentially over time for diseased individuals and the multivariate distributions are determined from the slope and intercept of the log of detected marker levels over time for individuals within the normal and diseased populations.
Claim 17
Dependent Claim
27 words
The method of claim 14 wherein random draws are used to compute average densities from the normal and disease populations given the marker levels for the individual.
Claim 18
Dependent Claim
48 words
A method as claimed in claim 16 wherein the risk is computed as a product of an odds factor and an estimate of prior odds, wherein the odds factor is the ratio of the average density from the disease population to the average density from the normal population.
Claim 19
Dependent Claim
27 words
A method as claimed in claim 16 wherein the risk is determined through addition of a time correlation component to a linear regression model of marker levels.
Claim 20
Dependent Claim
17 words
A method as claimed in claim 14 wherein the multivariate distribution is obtained by detecting plural markers.
Claim 21
Independent Claim
98 words
A method of assessing the risk of a woman for ovarian cancer, comprising: a) testing the woman to detect a level of a marker for ovarian cancer; b) computing risk of ovarian cancer from a detected level of the marker; and c) comparing the computed risk to thresholds to triage the woman into one of normal, borderline and elevated risk groups, wherein if the woman is triaged to a borderline risk group, the step of testing the woman to detect the level of the marker is repeated at a retest interval substantially less than a routine screening interval.
Claim 22
Independent Claim
98 words
A method of assessing the risk of a woman for ovarian cancer, comprising: a) testing the woman to detect a level of a marker for ovarian cancer; b) computing risk of ovarian cancer from a detected level of the marker; and c) comparing the computed risk to thresholds to triage the woman into one of normal, borderline and elevated risk groups, wherein if the woman is triaged to a borderline risk group, the step of testing the woman to detect the level of the marker is repeated at a retest interval substantially less than a routine screening interval.
Claim 23
Dependent Claim
46 words
A method as claimed in claim 20 wherein the marker level changes exponentially over time for diseased individuals and the multivariate distributions are determined from the slope and intercept of the log of detected marker levels over time for individuals within the normal and diseased populations.
Claim 24
Dependent Claim
27 words
The method of claim 21 wherein random draws are used to compute average densities from the normal and disease populations given the marker levels for the individual.
Claim 25
Dependent Claim
48 words
A method as claimed in claim 22 wherein the risk is computed as a product of the odds factor and an estimate of prior odds, wherein the odds factor is the ratio of the average density from the disease population to the average density from the normal population.
Claim 26
Dependent Claim
27 words
A method as claimed in claim 21 wherein the risk is determined through addition of a time correlation component to a linear regression model of marker levels.
Claim 27
Dependent Claim
17 words
A method as claimed in claim 20 wherein the multivariate distribution is obtained by detecting plural markers.
Claim 28
Independent Claim
70 words
A method of assessing the risk of an individual for a ovarian cancer comprising; testing the individual at plural times to detect a level of a marker to the disease; computing risk of ovarian cancer from a statistical analysis of detected marker levels relative to multivariate marker level distributions for tested normal and diseased populations; and determining a course of action for the individual based on the computed risk factor.
Claim 29
Independent Claim
70 words
A method of assessing the risk of an individual for a ovarian cancer comprising; testing the individual at plural times to detect a level of a marker to the disease; computing risk of ovarian cancer from a statistical analysis of detected marker levels relative to multivariate marker level distributions for tested normal and diseased populations; and determining a course of action for the individual based on the computed risk factor.
Claim 30
Dependent Claim
46 words
A method as claimed in claim 26 wherein the marker level changes exponentially over time for diseased individuals and the multivariate distributions are determined from the slope and intercept of the log of detected marker levels over time for individuals within the normal and diseased populations.
Claim 31
Dependent Claim
27 words
The method of claim 27 wherein random draws are used to compute average densities from the normal and disease populations given the marker levels for the individual.
Claim 32
Dependent Claim
48 words
A method as claimed in claim 28 wherein the risk is computed as a product of the odds factor and an estimate of prior odds, wherein the odds factor is the ratio of the average density from the disease population to the average density from the normal population.
Claim 33
Dependent Claim
27 words
A method as claimed in claim 27 wherein the risk is determined through addition of a time correlation component to a linear regression model of marker levels.
Claim 34
Dependent Claim
17 words
A method as claimed in claim 26 wherein the multivariate distribution is obtained by detecting plural markers.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 2001-08-31 | 2002-03-02 | 2002-09-01 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2005-08-31 | 2006-03-02 | 2006-09-01 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2009-08-31 | 2010-03-02 | 2010-09-01 | $7700.00 | Window Closed / Lapsed |