	US 12,378,608 B2
	Methods for developing urine biomarkers and for detecting bladder cancer
Robert Kitchen, Somerville, MA (US); Elena Castellanos-Rizaldos, Waltham, MA (US); Mia Sher, Maynard, MA (US); James Hurley, Marblehead, MA (US); Dalin Chan, Brighton, MA (US); Georg Stoll, Munich (DE); Wei Yu, Belmont, MA (US); and Johan Skog, Lincoln, MA (US)
Assigned to Exosome Diagnostics, Inc., Waltham, MA (US)
Appl. No. 15/734,363
Filed by Exosome Diagnostics, Inc., Waltham, MA (US)
PCT Filed Jun. 6, 2019, PCT No. PCT/US2019/035800 § 371(c)(1), (2) Date Dec. 2, 2020, PCT Pub. No. WO2019/236853, PCT Pub. Date Dec. 12, 2019.
Claims priority of provisional application 62/681,636, filed on Jun. 6, 2018.
Prior Publication US 2021/0230701 A1, Jul. 29, 2021
Int. Cl. C12Q 1/6886 (2018.01)

CPC C12Q 1/6886 (2013.01) [C12Q 2600/158 (2013.01)]

19 Claims

1. A method of treating bladder cancer in a human subject comprising:

determining the expression levels of DHRS2 and UPK2 in microvesicular nucleic acid extracted from a urine sample from the human subject;

normalizing the expression level of UPK2 to the expression level of DHRS2 to obtain a normalized expression level of UPK2;

comparing the normalized expression level of UPK2 to a predetermined cutoff value; and

administering to the human subject at least one therapeutically effective amount of at least one bladder cancer therapy when the normalized expression level of UPK2 is greater than the predetermined cutoff value.