# US 9,040,667 B2 · Antibody cocktail > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 9,040,667 B2 - Document ID: US9040667B2 - Status: Granted - Kind: B2 - Application number: 13/318,215 - Filed: 2010-04-27 - Published: 2012-04-05 - Granted: 2015-05-26 - Earliest claimed: 2009-05-01 - Assignees: Dako Denmark A/S - Applicants: Zhiming Liao; Jeanette Musser - Inventors: Zhiming Liao; Jeanette Musser - Web page: https://patentgrep.com/patent/US9040667B2 ## CPC - G01N 33/57555: of the prostate - G01N 2333/47: Assays involving proteins of known structure or function as defined in the subgroups - G01N 2333/4742: Keratin; Cytokeratin - G01N 2333/99: Isomerases (5.) - G01N 2800/52: Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis - G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q) ## Abstract The present invention relates to a composition comprising at least three primary antibodies or fragments thereof, wherein the at least three antibodies or fragments thereof binds specifically to at least three different proteins, and wherein the at least three different proteins are AMCAR, CK 5/6, and HMWC. Methods for using the composition in diagnosis, prognosis, and assessing efficacy of treatment is further included as well as kits comprising said composition, and optionally, instructions of its use. ## Claims ### Claim 1 A composition for detecting three different proteins, AMCAR, CK 5/6, and HMWCK, comprising three different primary antibodies or antigen-binding fragments thereof that bind specifically to the three different proteins, respectively, wherein the antibody recognizing AMCAR is an antibody produced by a rabbit clone 13H4 or an antigen-binding fragment thereof, wherein the antibody recognizing CK 5/6 is an antibody produced by a mouse clone D5/16 B4 or an antigen-binding fragment thereof, and wherein the antibody recognizing HMWCK is an antibody produced by a mouse clone 34βE12 or an antigen-binding fragment thereof, and wherein no additional primary antibodies or antigen-binding fragments thereof are present in the composition. ### Claim 2 (depends on 1) The composition according to claim 1, wherein at least one of the primary antibodies is a recombinant antibody. ### Claim 3 (depends on 1) The composition according to claim 1, further comprising a buffer. ### Claim 4 (depends on 1) A kit comprising: a. the composition of claim 1, and b. optionally, instructions for using the composition. ### Claim 5 (depends on 1) A method for in vitro detecting three different proteins in a biological sample, wherein the three different proteins are AMCAR, CK 5/6, and HMWCK, the method comprising the steps of a. contacting said sample with the composition of claim 1 for a sufficient time to form three different antigen-antibody complexes, and b. detecting said three different antigen-antibody complexes. ### Claim 6 (depends on 5) The method according to claim 5, further comprising a step of optionally scoring the amount of antigen-antibody complexes. ### Claim 7 (depends on 5) The method according to claim 5, further comprising step d) comparing the expression of said three proteins to at least one of a positive control and a negative control. ### Claim 8 (depends on 5) The method according to claim 5, which is performed on an automated staining device. ### Claim 9 (depends on 5) The method according to claim 5, wherein the detection is made manually. ### Claim 10 (depends on 5) The method according to claim 5, wherein the detection is made by image analysis. ### Claim 11 (depends on 5) The method according to claim 5, wherein the positive control comprises cells from a subject who is suffering from the prostate cancer, prostatic intraepithelial neoplasia (PIN), or benign mimics of prostate cancer. ### Claim 12 (depends on 5) The method according to claim 5, wherein the negative control comprises cells from a healthy subject who is not suffering from prostate cancer, prostatic intraepithelial neoplasia (PIN), or benign mimics of prostate cancer. ### Claim 13 (depends on 7) The method of claim 7, wherein the positive control comprises the proteins AMCAR, CK 5/6, and HMWCK. ### Claim 14 (depends on 7) The method of claim 7, wherein the negative control does not comprise the proteins AMCAR, CK 5/6, or HMWCK. ### Claim 15 (depends on 5) The method of claim 5, wherein the sample is obtained from a human prostate tissue sample. ### Claim 16 (depends on 15) The method of claim 15, wherein the prostate tissue sample is obtained from a subject that has, is suspected of having, or previously had prostate cancer, prostatic intraepithelial neoplasia (PIN), or benign mimics of prostate cancer. ### Claim 17 (depends on 1) A method for producing an antibody-labeled prostate sample, comprising: (i) providing a biological sample obtained from a sample of prostate tissue obtained from subject, and (ii) contacting the biological sample with the composition of claim 1; wherein the antibodies or antigen-binding fragments thereof bind to the sample to produce an antibody-labeled prostate sample. ### Claim 18 (depends on 17) The method of claim 17, further comprising detecting the bound antibodies or antigen-binding fragments thereof.