US 11,053,551 B2
Method and apparatus for determining a probability of colorectal cancer in a subject
Choong-Chin Liew, Toronto (CA); and Samuel Chao, Concord (CA)
Assigned to StageZero Life Sciences Ltd., Richmond Hill (CA)
Filed by GeneNews, Inc., Markham (CA)
Filed on Jan. 30, 2018, as Appl. No. 15/883,637.
Application 15/883,637 is a continuation of application No. 14/546,433, filed on Nov. 18, 2014, abandoned.
Application 14/546,433 is a continuation of application No. 12/384,914, filed on Apr. 10, 2009, granted, now 8,921,074, issued on Dec. 30, 2014.
Claims priority of provisional application 61/123,798, filed on Apr. 10, 2008.
Claims priority of provisional application 61/123,831, filed on Apr. 11, 2008.
Prior Publication US 2018/0163276 A1, Jun. 14, 2018
This patent is subject to a terminal disclaimer.
Int. Cl. C12Q 1/6886 (2018.01); G01N 33/574 (2006.01); G16B 25/00 (2019.01); G16B 5/00 (2019.01); G16B 40/00 (2019.01)
CPC C12Q 1/6886 (2013.01) [G01N 33/57419 (2013.01); G16B 5/00 (2019.02); C12Q 2600/118 (2013.01); C12Q 2600/158 (2013.01); C12Q 2600/16 (2013.01); C12Q 2600/166 (2013.01); G01N 2800/50 (2013.01); G01N 2800/56 (2013.01); G16B 25/00 (2019.02); G16B 40/00 (2019.02)] 3 Claims
 
1. A method of determining whether a human test subject requires an invasive screening procedure for colon cancer, the method comprising:
identification of whether the human test subject is more likely to have colorectal cancer than to not have colorectal cancer, the identification comprising:
a) amplifying test cDNA complementary to test mRNA to obtain values of levels of test cDNA corresponding to the test mRNA expressed specifically by each gene of a set of genes consisting of IL2RB, ANXA3, CLEC4D, LMNB1, PRRG4, TNFAIP6 and VNN1 comprising the steps of:
i) generating test cDNA from the test mRNA expressed specifically by each gene of the set of genes from blood of the human test subject;
ii) reacting each test cDNA under conditions to amplify the test cDNA with a primer pair for said cDNA, wherein each primer pair consists of a forward primer and a reverse primer; and
iii) obtaining the values of the levels of the test cDNA corresponding to the test mRNA expressed specifically by each of the IL2RB, ANXA3, CLEC4D, LMNB1, PRRG4, TNFAIP6, and VNN1 genes:
b) obtaining a set of 6 ratios, each ratio being obtained by normalizing the level of the test cDNA corresponding to the test mRNA expressed specifically by each of the ANXA3, CLEC4D, LMNB1, PRRG4, TNFAIP6, and VNN1 genes against the level of the test cDNA corresponding to the test mRNA expressed by the IL2RB gene; and
c) applying each of the 6 ratios to a mathematical model formulated by analyzing, using logistic regression, a training set of training set ratios, said training set ratios being obtained from levels of cDNA corresponding to mRNA expressed by each of the ANXA3, CLEC4D, LMNB1, PRRG4, TNFAIP6, and VNN1 genes, in blood of training subjects having colorectal cancer and training subjects not having colorectal cancer, normalized to levels cDNA corresponding to mRNA expressed by the IL2RB gene in the blood of said training subjects, to determine the probability that a test subject has colorectal cancer as opposed to not having colorectal cancer
wherein when the human test subject is identified as more likely to have colorectal cancer than to not have colorectal cancer as a result of said identification, determining that the human test subject requires the invasive screening procedure for colon cancer, the invasive screening procedure being selected from the group consisting of colonoscopy, sigmoidoscopy, and combinations thereof.