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 comprising:
a) obtaining a sample from a human subject asymptomatic for lung cancer;
b) measuring a panel of markers in the sample, wherein at least one of the markers is selected from CEA, CA125, Cyfra 21-1, Pro-GRP and at least a second marker is an autoantibody;
c) determining a composite score for each human subject based on the measured panel of markers;
d) quantifying an increased 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 a grouping of stratified human subject populations wherein each risk category comprises a multiplier indicating increased likelihood of having the lung cancer correlated to a range of composite scores; and,
e) administering a computerized tomography (CT) scan to the human subject with a quantified increased risk for the presence lung cancer.
2. The method of claim 1 , wherein the range of composite scores are determined from positive predicative scores of retrospective samples.
3. The method of claim 1 , wherein the autoantibody is selected from anti-NY-ESO-1, anti-MAPKAPK3, anti-Cyclin E2 and anti-p53.
4. The method of claim 1 , wherein the risk category further comprises a risk identifier.
5. The method of claim 4 , wherein the risk identifier is selected from low risk, intermediate-low risk, intermediate risk, intermediate-high risk and high risk.
6. The method of claim 1 , wherein the human subject is aged 50 years or older and has a history of smoking tobacco.
7. The method of claim 1 , wherein the sample is blood, blood serum, blood plasma, or some part thereof.
8. A method comprising:
a) obtaining a sample from a human subject asymptomatic for lung cancer;
b) measuring a panel of markers in the sample wherein at least one of the markers is selected from CEA, CA125, Cyfra 21-1, Pro-GRP and at least a second marker is selected from anti-NY-ESO-1, anti-p53, anti-Cyclin E2 and anti-MAPKAPK3;
c) determining a composite score for each human subject based on the measured panel of markers;
d) quantifying an increased 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 a grouping of stratified human subject populations wherein each risk category comprises a multiplier indicating increased likelihood of having the lung cancer correlated to a range of composite scores; and,
e) administering a computerized tomography (CT) scan to the human subject with a quantified increased risk for the presence lung cancer.
9. The method of claim 8 , wherein the range of composite scores are determined from positive predicative scores of retrospective samples.
10. The method of claim 8 , wherein the markers are selected from CEA, CA125, Cyfra 21-1, anti-NY-ESO-1 and anti-p53.
11. The method of claim 8 , wherein the risk category further comprises a risk identifier.
12. The method of claim 11 , wherein the risk identifier is selected from low risk, intermediate-low risk, intermediate risk, intermediate-high risk and high risk.
13. The method of claim 8 , wherein the human subject is aged 50 years or older and has a history of smoking tobacco.
14. The method of claim 8 , wherein the sample is blood, blood serum, blood plasma, or some part thereof.