mcd2inga stated: "Just a question. If a patent is for a test that includes 30 or so different biomarker tests, would the patent have to be revised if the test was desired to only use 27 of the original biomarkers? I would think increasing the numer to 31 would require a revision but don't know about dropping individual tests out of the group."
What is attempted to be patented is not specific test or group of tests but a method of scoring a test or group of tests. The list of markers were examples of markers that could be used. Others probably could be added and those listed need not be part of the scoring. This patent is the method of scoring, not a specific test or specific combination of tests.
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What is claimed is:
1. A method for scoring one or more markers in or associated with a test sample obtained from a subject, the method comprising the steps of:
a. quantifying the amount of at least one marker in or associated with a test sample obtained from a subject, wherein the marker is a biomarker, a biometric parameter or a combination of a biomarker and a biometric parameter;
b. comparing the amount of each marker quantified to a number of predetermined cutoffs for said marker, wherein the predetermined cutoffs are based on ROC curves,
c. assigning a score for each marker based on the comparison in step b, wherein the score for each marker is calculated based on the specificity of the marker; and
d. combining the assigned score for each marker from step c to come up with a total score for said subject.
2. A method for determining a subject's risk of developing a medical condition, the method comprising the steps of:
a. quantifying the amount of at least one marker in or associated with a test sample obtained from said subject;
b. comparing the amount of each marker quantified to a number of predetermined cutoffs for said marker and assigning a score for each marker based on said comparison;
c. combining the assigned score for each marker quantified in step b to come up with a total score for said subject;
d. comparing the total score determined in step c with a predetermined total score; and
e. determining whether said subject has a risk of developing a medical condition based on the total score determined in step f.
3. The method of claim 2, wherein the marker is a biomarker, a biometric parameter or a combination of a biomarker and a biometric parameter.
4. The method of claim 2, wherein the predetermined cutoffs are based on ROC curves.
5. The method of claim 2, wherein the score for each marker is calculated based on the specificity of the marker.
6. The method of claim 2, wherein the medical condition is cardiovascular disease, renal or kidney disease, cancer, a neurological or neurodegenerative disease, an autoimmune disease, liver disease or injury or a metabolic disorder.
7. The method of claim 2, further comprising determining the stage of the medical condition based on the total score determined in step f.
8. A method for determining a subject's risk of developing a medical condition, the method comprising the steps of:
a. quantifying the amount of at least one marker in or associated with a test sample obtained from said subject, wherein the marker is a biomarker, a biometric parameter or a combination of a biomarker and a biometric parameter;
b. comparing the amount of each marker quantified to a number of predetermined cutoffs for said marker, wherein said predetermined cutoffs are based on ROC curves,
c. assigning a score for each marker based on the comparison in step b wherein the score for each marker is calculated based on the specificity of the marker;
d. combining the assigned score for each marker from step c to come up with a total score for said subject;
e. comparing the total score determined in step d with a predetermined total score; and
f. determining whether said subj ect has a risk of developing
a medical condition based on the total score determined in step e.
9. The method of claim 8, wherein the medical condition is cardiovascular disease, renal or kidney disease, cancer, a neurological or neurodegenerative disease, an autoimmune disease, liver disease or injury or a metabolic disorder.
10. An apparatus for diagnosing a medical condition of a subject, said apparatus comprising:
a. a correlation of the amount of at least one marker in or associated with a test sample obtained from a subject with the occurrence of the medical condition in reference subjects, said at least one marker selected from the group consisting of at least one biomarker, at least one biometric parameter, and the combination of at least one biomarker and at least one biometric parameter; and
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