Methods and algorithms for aiding in the detection of cancer
A method of data interpretation from a multiplex cancer assay is described. The aggregate normalized score from the assay is transformed to a quantitative risk score quantifying a human subject's increased risk for the presence of cancer as compared to the known prevalence of the cancer in the population before testing the subject.
1. A method of identifying and treating an asymptomatic human subject with a risk for increased lung cancer, compared to an at-risk cohort, wherein individuals in the at-risk cohort are aged 50 years or older and have at least a 20 pack year history of smoking tobacco, comprising:
a) obtaining a sample from the human subject asymptomatic for lung cancer, wherein the sample is blood, blood serum, blood plasma, or some part thereof;
b) measuring a panel of markers in the sample, wherein at least one of the markers is selected from CEA, CA125, Cyfra 21-1, or Pro-GRP;
c) determining a composite score for the human subject based on the measured panel of markers;
d) quantifying the risk for a presence of lung cancer for the asymptomatic human subject as a risk score, wherein the composite score is matched to a risk category of the at-risk cohort wherein each risk category comprises a multiplier indicating increased likelihood of having lung cancer
e) administering a computerized tomography (CT) scan to the human subject with a quantified increased risk for the presence of lung cancer and,
surgically removing cancerous tumors identified on the CT scan.
2. The method of claim 1 , wherein the the risk categories of the at-risk cohort are determined from positive predictive scores of retrospective samples.
3. The method of claim 1 , wherein the risk category further comprises a risk identifier.
4. The method of claim 3 , wherein the risk identifier is selected from low risk, intermediate-low risk, intermediate risk, intermediate-high risk and high risk.
5. A method of identifying and treating an asymptomatic human subject with a risk for increased lung cancer, as compared to an at-risk cohort, wherein individuals in the at-risk cohort are aged 50 years or older and have at least a 20 pack year history of smoking tobacco, comprising:
a) obtaining the sample from a human subject asymptomatic for lung cancer, wherein the sample is blood, blood serum, blood plasma, or some part thereof;
b) measuring a panel of markers in the sample comprising the markers CEA, CA125, and Cyfra 21-1;
c) determining a composite score for the human subject based on the measured panel of markers;
d) quantifying the risk for a presence of lung cancer for the asymptomatic human subject as a risk score, wherein the composite score is matched to a risk category of the at-risk cohort wherein each risk category comprises a multiplier indicating increased likelihood of having lung cancer;
e) administering a computerized tomography (CT) scan to the human subject with a quantified increased risk for the presence of lung cancer; and,
surgically removing cancerous tumors identified on the CT scan.
6. The method of claim 5 , wherein the the risk categories of the at-risk cohort are determined from positive predictive scores of retrospective samples.
7. The method of claim 5 , wherein the risk category further comprises a risk identifier.
8. The method of claim 5 , wherein the risk identifier is selected from low risk, intermediate-low risk, intermediate risk, intermediate-high risk and high risk.