Determining disease states using biomarker profiles

A method of profiling the recency of a disease, comprising the steps of:

• obtaining at least a first set of diseased biological samples from subjects known to have a first state of the disease and a second set of diseased biological samples from subjects known to have a second state of the disease, each biological sample comprising a plurality of biomarkers, wherein the first state of the disease and the second state of the disease are differentiated by a predetermined period of time;
• and
• for each sample, measuring the concentration of a set of biomarkers from among the plurality of biomarkers;
• and
• using multivariate statistical analysis, generating a profile for each state of the disease, each profile comprising the concentrations from a plurality of samples.

A method of determining the state of a disease in a subject, the method comprising the steps of:

• obtaining a plurality of sets of diseased biological samples from subjects, each subject having a known state of the disease, the disease comprising cancer, each biological sample comprising a plurality of biomarkers, wherein each state of the cancer being one of aggressive, active, acute, recent, chronic, indolent, non-recent, primary, persistent, remission or subclinical;
• for each sample, measuring the concentration of a set of biomarkers from among the plurality of biomarkers and generating a profile for each state of the cancer, each profile comprising the concentrations from a plurality of samples from subject having the same state of the cancer;
• obtaining a biological sample from a subject having an unknown state of the cancer and measuring the concentration of a set of biomarkers from among the plurality of biomarkers and generating a profile for the unknown state of the cancer;
• and
• comparing the profile for the unknown state of the cancer to the profile of at least two states of the cancer determine whether the subject has one of the states of the cancer.