1111111111111111 IIIIII IIIII 1111111111 11111 11111 111111111111111 1111111111 1111111111 11111111 US 20200081016Al c19) United States c12) Patent Application Publication c10) Pub. No.: US 2020/0081016 Al Talaat et al. (43) Pub. Date: Mar. 12, 2020 (54) BIOMARKERS FOR EARLY DIAGNOSIS Publication Classification AND DIFFERENTIATION OF (51) Int. Cl. MYCOBACTERIAL INFECTION GOIN 33/68 (2006.01) C12Q 116851 (2006.01) (71) Applicant: Wisconsin Alumni Research GOIN 33/569 (2006.01) Foundation, Madison, WI (US) (52) U.S. Cl. (72) Inventors: Adel Mohamed Talaat, Madison, WI CPC ......... GOIN 33/6854 (2013.01); GOIN 33/68 (US); Chia-wei Wu, Madison, WI (US) (2013.01); GOIN 2800/50 (2013.01); GOIN 33/5695 (2013.01); GOIN 2800/26 (2013.01); (21) Appl. No.: 16/555,819 C12Q 116851 (2013.01) (22) Filed: Aug. 29, 2019 (57) ABSTRACT Mycobacterial-specific biomarkers and methods of using Related U.S. Application Data such biomarkers for diagnosis of mycobacterial infection in (60) Provisional application No. 62/728,387, filed on Sep. a mammal are disclosed. 7, 2018. Specification includes a Sequence Listing. 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MYCOBACTERIAL INFECTION SUMMARY OF THE INVENTION CROSS-REFERENCE TO RELATED [0009] The present invention overcomes the aforemen­ APPLICATIONS tioned drawbacks by providing a set of biomarkers to [0001] This application claims priority to U.S. Provisional diagnose infected animals and distinguishing between vac­ Patent Application No. 62/728,387 filed Sep. 7, 2018, which cinated and infected animals. is incorporated herein in its entirety. [0010] In a first aspect, provided herein is a method for diagnosis of mycobacterial infection in a mammal, the STATEMENT REGARDING FEDERALLY method comprising the steps of a) obtaining a first type of SPONSORED RESEARCH sample from the mammal; b) measuring the expression level in the sample of at least one biomarker selected from the [0002] This invention was made with govermnent support group consisting of LOC108634521, LOC108637251, under 2013-67015-21347, 2018-67015-28243 and 2016- LOC108637252, LOC108634594, FAM198B, 33610-25438 awarded by the USDA/NIFA. The government LOC108637671, CDCPl, TMTCl, BAIAP2Ll, MEIi, has certain rights in the invention. SEPTl0, IFNG, IL17F, FCER2, ADGRGl, APBBl, PIWIL2, AOAH, and homologs thereof and comparing the REFERENCE TO A SEQUENCE LISTING level