US 12,000,001 B2
Methods of detecting bladder cancer
Leena McCann, Santa Clara, CA (US); Stacey Ellen Wallace, Sunnyvale, CA (US); Edwin Wei-Lung Lai, Menlo Park, CA (US); and Russell Higuchi, Alameda, CA (US)
Assigned to Cepheid, Sunnyvale, CA (US)
Filed by Cepheid, Sunnyvale, CA (US)
Filed on May 14, 2019, as Appl. No. 16/411,485.
Application 16/411,485 is a division of application No. 14/199,292, filed on Mar. 6, 2014, granted, now 10,329,622.
Claims priority of provisional application 61/773,724, filed on Mar. 6, 2013.
Prior Publication US 2019/0382847 A1, Dec. 19, 2019
Int. Cl. C12Q 1/6886 (2018.01)
CPC C12Q 1/6886 (2013.01) [C12Q 2600/106 (2013.01); C12Q 2600/158 (2013.01)] 25 Claims
 
1. A method of monitoring anti-androgen therapy response in a human subject with bladder cancer comprising detecting the levels of each marker of a set of three to six bladder cancer markers in a sample from the subject at a first time point; detecting the levels of each marker of the set of bladder cancer markers at a second time point that is after the first time point; and comparing the levels of each marker at the first time point to the levels of each marker at the second time point, wherein the set of bladder cancer markers comprises uroplakin 1B (UPK1B) and insulin-like growth factor 2 (IGF2) and at least one marker selected from androgen receptor (AR), corticotrophin releasing hormone (CRH), keratin 20 (KRT20), and annexin 10 (ANXA10), wherein the subject is undergoing anti-androgen therapy at the second time point, wherein detecting comprises contacting RNA from the sample with a set of bladder cancer marker primer pairs comprising a primer pair for detecting UPK1B and a primer pair for detecting IGF2, forming a set of bladder cancer marker amplicons, and contacting the bladder cancer marker amplicons with a set of bladder cancer marker probes comprising a probe for detecting the UPK1B amplicon and a probe for detecting the IGF2 amplicon, wherein the probe for detecting the IGF2 amplicon comprises at least 8 contiguous nucleotides of SEQ ID NO: 34, wherein each probe is less than 30 nucleotides long, and wherein a decrease in the level of at least one marker in the set of bladder cancer markers at the second time point relative to the first time point indicates that the subject is responding to anti-androgen therapy.