US 12,332,245 B2
Cancer biomarkers and methods of use thereof
Thea D. Tlsty, San Francisco, CA (US); Hal K. Berman, Toronto (CA); Mona L. Gauthier, Toronto (CA); Bob Y. Liu, San Francisco, CA (US); Colleen A. Fordyce, San Francisco, CA (US); Curtis R. Pickering, San Francisco, CA (US); Paul A. Reynolds, San Francisco, CA (US); Nancy Dumont, San Francisco, CA (US); and Geoffrey M. Benton, San Francisco, CA (US)
Assigned to THE REGENTS OF THE UNIVERSITY OF CALIFORNIA, Oakland, CA (US)
Filed by THE REGENTS OF THE UNIVERSITY OF CALIFORNIA, Oakland, CA (US)
Filed on May 18, 2022, as Appl. No. 17/664,006.
Application 17/664,006 is a continuation of application No. 15/284,349, filed on Oct. 3, 2016.
Application 15/284,349 is a continuation of application No. 12/373,047, abandoned, previously published as PCT/US2007/015584, filed on Jul. 3, 2007.
Claims priority of provisional application 60/830,960, filed on Jul. 14, 2006.
Prior Publication US 2023/0204591 A1, Jun. 29, 2023
Int. Cl. C12Q 1/68 (2018.01); G01N 33/574 (2006.01)
CPC G01N 33/57492 (2013.01) [G01N 33/57415 (2013.01)] 21 Claims
 
1. A method of treating breast cancer in a subject, comprising:
collecting a biological sample from a subject having at least one of ductal carcinoma in situ (DCIS) or atypical ductal hyperplasias (ADH);
detecting a mammary epithelial cell signature for the biological sample by contacting the biological sample with a composition comprising at least three detection reagents, wherein the at least three detection reagents comprise:
a first detection reagent that binds to a first mammary epithelial cell structure, the first mammary epithelial cell structure selected from the group consisting of a p16 protein and an mRNA encoding the p16 protein, wherein the first detection reagent comprises an antibody, or a nucleic acid;
a second detection reagent that binds to a second mammary epithelial cell structure, the second mammary epithelial cell structure selected from the group consisting of a Ki67 protein and an mRNA encoding the Ki67 protein, wherein the second detection reagent comprises an antibody, or a nucleic acid; and
a third detection reagent that binds to a third mammary epithelial cell structure, the third mammary epithelial cell structure selected from the group consisting of a COX-2 protein and an mRNA encoding the COX-2 protein, wherein the third detection reagent comprises an antibody, or a nucleic acid,
wherein each of the first, second and third detection reagents comprises a detectable label, and wherein the detectable labels of the first, second, and third detection reagents are different from each other;
upon determining that the detected mammary epithelial cell signature comprises an elevated level of expression of each of the first, second and third mammary epithelial cell structures compared to respective control levels of expression of the first, second and third mammary epithelial cell structures, providing a treatment to the subject, wherein the treatment comprises:
a) lumpectomy with an additional therapy; or
b) mastectomy.